<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01698047</url>
  </required_header>
  <id_info>
    <org_study_id>CCF-12-001142</org_study_id>
    <secondary_id>CMCH 12-97088</secondary_id>
    <nct_id>NCT01698047</nct_id>
  </id_info>
  <brief_title>Building Resiliency and Increasing Community Hope</brief_title>
  <acronym>BRICH</acronym>
  <official_title>Building Resiliency and Increasing Community Hope</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to build a scientific evidence base for the training and&#xD;
      delivery of a depressive symptoms education program, developed by local community members,&#xD;
      called a Resiliency Class (RC). The RC has strong elements of Cognitive Behavioral Therapy&#xD;
      and is designed to be delivered as a psycho-educational class by non-professionals to improve&#xD;
      mood. Depressive symptoms are common, especially in low-income, minority communities.&#xD;
      Depressive symptoms that don't meet DSM-IV criteria for Major Depression still carry a&#xD;
      significant amount of disability. Interventions that address sub-threshold depressive&#xD;
      symptoms have been noted to result in a decreased likelihood of depression and diminished use&#xD;
      of mental health services. Few interventions using a health education / health promotion&#xD;
      focus are designed to be delivered by non-professionals to address individuals with mild to&#xD;
      moderate depressive symptoms in low income, minority communities. This project will take&#xD;
      place in the Centinela Valley, which roughly corresponds to Service Planning Area (SPA) 6 or&#xD;
      South Los Angeles (SLA). This single-blind, randomized trial will utilize a wait-list control&#xD;
      design where half of the participants enrolled in the study will be randomized to the&#xD;
      Resiliency Class (7 sessions) and half will go to a wait-list control condition where they&#xD;
      will receive 2 case management calls and referrals to social services. We propose to screen&#xD;
      1500 clients to detect about 450 participants with depressive symptoms (endorsed one item on&#xD;
      the PHQ-2). We plan to enroll 400 participants, 200 in the resiliency class and 200 in the&#xD;
      wait-list control condition. Primary outcomes measures will include depressive symptoms,&#xD;
      function, and measures of resiliency. We will assess these measures at baseline and at 3&#xD;
      months after completion of the Resiliency Class or wait-list condition. After the completion&#xD;
      of the first round of classes, we will conduct a preliminary analysis of the impact of the&#xD;
      resiliency classes versus the wait-list control case management calls on depressive symptoms.&#xD;
      If the resiliency classes improve depressive symptoms more than the wait-list control, we&#xD;
      will offer wait-list controls access to the resiliency classes and then disseminate the&#xD;
      resiliency class through trainings.&#xD;
&#xD;
      We hypothesize that the resiliency classes will lead to greater reductions in client&#xD;
      depressive symptoms than the wait-list case management calls in the randomized trial of this&#xD;
      project.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      B-RICH proposes to pilot and then conduct a randomized, single blind trial of a psychosocial&#xD;
      intervention called a &quot;Resiliency Class&quot; (RC), to provide depression education and health&#xD;
      promotion to individuals with depressive symptoms, by training non-professionals to offer&#xD;
      this class to clients receiving services within diverse community settings (e.g. health care&#xD;
      clinic, church, community advocacy organization, social services agency). This class is not&#xD;
      designed to be therapy, but rather is designed as a class that is informed on cognitive&#xD;
      behavioral therapy (CBT) principles used to address depressive symptoms, on how to improve&#xD;
      mood, and to enhance resiliency in the face of stress.&#xD;
&#xD;
      The Resiliency Class is a manualized, CBT informed, seven session, psycho-educational&#xD;
      intervention designed to be delivered by non-licensed teachers in both English and Spanish to&#xD;
      address depressive symptoms. Each session is designed to be between 90-120 minutes. Some of&#xD;
      the goals of the RC are: 1) to provide psycho-education on mood and depressive symptoms; 2)&#xD;
      to provide this education through teachers who are not health or mental healthcare&#xD;
      professionals in order to improve access to depression education and to offer approaches to&#xD;
      improve depressive symptoms; 3) to deliver this class in non-health care or mental health&#xD;
      care settings like churches or in trusted community locations (e.g. parks and recreation,&#xD;
      primary care, social services agencies, job retraining centers, senior centers) instead of as&#xD;
      &quot;therapy&quot; or in mental health settings so that individuals would not feel stigmatized; 4) to&#xD;
      design the manual so that it will be usable by class participants with low literacy levels in&#xD;
      both English and Spanish.&#xD;
&#xD;
      The specific aims for this study are to:&#xD;
&#xD;
        1. Pilot a revised resiliency class intervention led by non-professionals in 20 individuals&#xD;
           with depressive symptoms for acceptability;&#xD;
&#xD;
        2. Revise the resiliency class intervention based on therapist's experience from the pilot&#xD;
           based on feedback from both the instructors and the pilot class participants;&#xD;
&#xD;
        3. Conduct a randomized, single blind trial of the resiliency class (study group) versus&#xD;
           case management social services assessment and referrals (control group) to assess their&#xD;
           differential impact on depressive symptoms in 400 study participants (200 in each arm of&#xD;
           the study).&#xD;
&#xD;
      There will be several steps to the implementation of the B-RICH Study. Phase I&#xD;
&#xD;
        1. We will conduct a pilot of the Resiliency Class Manual with 2 instructors and 20&#xD;
           individuals divided in two classes in the fall of 2012. We will screen 100 clients at&#xD;
           Healthy African American Families II and the 1st African Presbyterian Church located in&#xD;
           South Los Angeles to detect approximately 70 potential participants with depressive&#xD;
           symptoms using the Patient Health Questionnaire 2 (PHQ-2). Participants who endorse one&#xD;
           item on the PHQ-2, are 18 years or older, can attend six 90-120 minute weekly Resiliency&#xD;
           Classes, and have a PHQ-8 score less than 15 (on the baseline interview) will be&#xD;
           eligible to enroll in the Resiliency Class. These classes will be delivered by a&#xD;
           non-licensed, individual who would be the equivalent of a community health worker. The&#xD;
           classes will be supervised by Bowen Chung and Jeanne Miranda. In this phase of the&#xD;
           study, we will pilot the participant screener, baseline interview, and follow-up&#xD;
           interview for feasibility and to assess the amount of time each instrument will require.&#xD;
&#xD;
        2. Based on the class instructor's feedback and focus groups with the pilot class study&#xD;
           participants, the PI, Co-PI, and project manager will then re-revise the manual for a&#xD;
           final version which will be utilized in the randomized trial of the resiliency class&#xD;
           (study group) versus 2 case management calls (control group) that will be started in&#xD;
           January 2013.&#xD;
&#xD;
      Phase II 4) We will conduct a randomized trial of the Resiliency Class (study group) compared&#xD;
      to telephone case management social services assessment (control group) and referrals,to&#xD;
      ascertain their differential impact on depressive symptoms between January 2013 and January&#xD;
      2014.&#xD;
&#xD;
      4a) We will screen 1000 clients at the partner agencies for potential study participation.&#xD;
      Entry criteria will include those individuals age 18 or older who endorse at least one item&#xD;
      on the Patient Health Questionnaire- 2 (PHQ-2), have a reliable way to contact them by phone,&#xD;
      and are able to attend our six, weekly sessions of the Resiliency Class. We estimate that&#xD;
      screening will take place between January 2013 and June 2013.&#xD;
&#xD;
      4b) We plan on enrolling 400 clients into the study. 4c) Enrolled participants will then be&#xD;
      offered a 45 minute baseline interview, that will collect data on income, housing, functional&#xD;
      status (short form health survey - 12 item or SF-12); medical conditions; mental health&#xD;
      conditions; alcohol and substance use; use of health and mental health services; knowledge,&#xD;
      attitudes, and beliefs about depression; housing; food insecurity; coping strategies;&#xD;
      medication use; satisfaction with services; and health insurance status. We will also collect&#xD;
      contact information as well as information about 3 people who will always know how to reach&#xD;
      the participant in case their direct contact information becomes invalid due to a&#xD;
      disconnected phone or a change in address. The baseline interview will be conducted at the&#xD;
      time of recruitment in the community at study agencies after determining study eligibility or&#xD;
      on the phone either on a laptop computer or using pencil and paper by a study research&#xD;
      assistant. We will exclude enrolled participants with a PHQ-8 score of 20 or greater (severe&#xD;
      depression) and refer them to local mental health agencies in the area.&#xD;
&#xD;
      4d) After being enrolled in the study and completing the baseline interview, participants&#xD;
      will either be randomized to the control group (two case management phone calls) or to the&#xD;
      study group (a seven session resiliency class).&#xD;
&#xD;
      4e) Participants randomized to the control group will receive two calls from a case manager&#xD;
      of the participating partner agencies within the first two months of their enrollment. These&#xD;
      phone calls will ask the study participants if they should need referrals in the local&#xD;
      community for healthcare, mental health care, substance use, job retraining, and social&#xD;
      services. If the participants are in need of referrals, they will be offered a phone number&#xD;
      and address for an agency that will meet their needs.&#xD;
&#xD;
      4f) Participants randomized to the study group will then be offered enrollment in a&#xD;
      Resiliency Class that will take place at the agency they were screened at.&#xD;
&#xD;
      4g) The study group will have staggered starting times that will depend on success of&#xD;
      participant enrollment. Each weekly, 90-120 minute class will have 10-12 study participants.&#xD;
      Each participant in the Resiliency Class will receive a copy of the study manual at the&#xD;
      initial class. In addition, the class instructor will provide light snacks and refreshments&#xD;
      to participants at each class. Class instructors will be a combination of study staff as well&#xD;
      as staff from partner agencies.&#xD;
&#xD;
      4h) Study Participants in both arms of the study will receive a 3-month, telephone follow-up&#xD;
      interview assessing measures on the baseline interview that should take about 45 minutes.&#xD;
&#xD;
      4i) Research staff interviewing participants in baseline and follow-up interviews will be&#xD;
      blinded as to the intervention status of the study participants.&#xD;
&#xD;
      5) We will conduct data analysis on the primary outcome measures, depressive symptoms as&#xD;
      assessed by the PHQ-8. If the Resiliency Class shows a greater impact on diminishing&#xD;
      depressive symptoms, the primary study outcome measure, than the case management phone calls,&#xD;
      we will contact all participants in the case management arm of the study and offer the&#xD;
      resiliency classes to those participants free of charge, as well as offer training to all&#xD;
      staff from agencies interested in implementing the resiliency class intervention.&#xD;
&#xD;
      Phase I: Resiliency Class Pilot Intervention The goal of this step of the study is to pilot&#xD;
      the Resiliency Class in order to assess for feasibility and to determine if the intervention&#xD;
      might need additional changes to improve delivery of the intervention from the perspective of&#xD;
      the class instructors.&#xD;
&#xD;
      Screening and Recruitment of Pilot Participants Study research assistants will use the&#xD;
      screening script in to recruit potential participants at the pilot sites: Healthy African&#xD;
      American Families II and the 1st African Presbyterian Church. A table with a sign promoting&#xD;
      the study will be set up at the recruitment site and a study brochure will be distributed to&#xD;
      individuals interested in the study. Research staff will then obtain oral consent and screen&#xD;
      potential participants one-on-one by telephone or in person to determine eligibility. The&#xD;
      screening instrument contains questions on race/ethnicity, age, gender, language, and&#xD;
      depressive symptoms. As part of the screener, we will use the PHQ-2 to assess probable&#xD;
      depression. It will take no more than 10 minutes to complete the entire screener. Screeners&#xD;
      that are administered in person will be done in a private room at the recruitment site. All&#xD;
      measures will be administered in a private room on a one-to-one basis at the recruitment&#xD;
      site. Potential study participants will be offered a monetary incentive for being screened&#xD;
      for the study as well as a resource guide that lists agencies that provide health care,&#xD;
      mental health, substance use, social services, child welfare services, and prison re-entry&#xD;
      programs in South Los Angeles.&#xD;
&#xD;
      B-RICH Phase I, Pilot Inclusion Criteria&#xD;
&#xD;
        1. Age 18 or older&#xD;
&#xD;
        2. Endorse one item on the PHQ-2&#xD;
&#xD;
        3. Able to be contacted by phone&#xD;
&#xD;
        4. Able to participate in the six, weekly 90-120 minute sessions of the Resiliency Classes&#xD;
&#xD;
        5. English or Spanish speaker&#xD;
&#xD;
      B-RICH, Phase I Pilot Exclusion Criteria&#xD;
&#xD;
        1. Under age 18 years&#xD;
&#xD;
        2. Endorse no items on PHQ-2 screener&#xD;
&#xD;
        3. PHQ-8 score of 15 or greater on the baseline interview&#xD;
&#xD;
      3) Unable to be contacted by phone 4) Unable to attend the weekly resiliency classes&#xD;
&#xD;
      Pilot Consenting Process If participants are eligible for the study, the UCLA research&#xD;
      assistant will offer the participant the IRB approved Pilot Non-Randomized consent form at&#xD;
      the time of screening and will explain the full study procedures to the potential study&#xD;
      participant. UCLA Research assistants will explain the IRB-approved consent and assure that&#xD;
      the participant will have enough time to read and review the consents before signing. The&#xD;
      potential participant will be informed verbally in the consent form, that the study involves&#xD;
      baseline and follow-up interviews, as well as a manualized class that will teach the&#xD;
      participant how to improve their mood, and that this class will be audio tape recorded for&#xD;
      review by Bowen Chung and / or Jeanne Miranda to assess the instructors' skill and to provide&#xD;
      feedback on how to improve teaching the class.&#xD;
&#xD;
      The research assistants will determine each potential participant's level of comprehension of&#xD;
      the material presented by asking the participants to summarize in their own words how they&#xD;
      understand the study procedures, what will be required of them, potential risks and benefits&#xD;
      of study participation, the voluntary nature of the study, and their right to withdraw at any&#xD;
      time. They will be encouraged to ask questions about the study, study procedures, as well as&#xD;
      interviews. Potential participants will be allowed to consent at the initial visit or they&#xD;
      will offered up to one week to consider their participation and to either mail or fax their&#xD;
      consent form back to the UCLA research assistant so that they will have an opportunity to&#xD;
      think about study participation and / or discuss potential study participation with family&#xD;
      members or friends. All study participants will understand that their acceptance or refusal&#xD;
      to participate in the study will in no way affect their ability to receive services or care&#xD;
      at the agency they were screened at or any other B-RICH partner agency. In addition, they&#xD;
      will be informed that they will be able to withdraw their consent and discontinue study&#xD;
      participation at any time without any adverse consequences. If the potential participant has&#xD;
      any questions, they can call and request to meet with the study investigators and the project&#xD;
      manager at any time.&#xD;
&#xD;
      Pilot Baseline Assessments If they agree to participate in the study, participants will be&#xD;
      asked to take part in the 45 minute baseline interview either in person when the consent has&#xD;
      been signed or over the phone at a later time and date. Baseline interview will be conducted&#xD;
      by a UCLA Research Assistant.&#xD;
&#xD;
      Pilot Resiliency Class After completion of the interview, the participant will be offered and&#xD;
      assigned a time and date to attend the classes at either Healthy African American Families II&#xD;
      or at the 1st African Presbyterian Church. In order to facilitate their participation in the&#xD;
      class, they will be offered bus tokens for transportation to attend the first three classes.&#xD;
      Each class will have up to 10 participants.&#xD;
&#xD;
      The instructors for the class will be a UCLA research study staff member and a staff member&#xD;
      from Healthy African American Families II or the 1st African Presbyterian Church.&#xD;
&#xD;
      Classes will be 90-120 minutes in duration and will be held weekly for six weeks. At the&#xD;
      classes, participants will be offered a copy of the Resiliency Class Manual. And at each&#xD;
      class, light snacks and refreshments will be offered.&#xD;
&#xD;
      Each class will be audio recorded on a digital audio recorder for review by Bowen Chung and /&#xD;
      or Jeanne Miranda to provide feedback on the class instructor's technique of delivering this&#xD;
      educational intervention. The audio tapes will be uploaded to a HIPAA compliant, password&#xD;
      protected website housed on a secure server at the UCLA Center for Health Services and&#xD;
      Society. After review of the audio taped sessions, the data for these sessions will be&#xD;
      destroyed. These audio recordings will not be used for research purposes, but merely to&#xD;
      assess the instructor's skill and to provide feedback on how to improve teaching the class.&#xD;
&#xD;
      The Pilot Resiliency Class manual covers the following topics:&#xD;
&#xD;
      Session 1 - &quot;What Affects Your Mood and Resilience&quot; Session 2 - &quot;Pleasant Activities Can Help&#xD;
      Improve Your Mood and Make You Resilient&quot; Session 3 - &quot;What Gets In The Way of Pleasant&#xD;
      Activities: Harmful Thoughts and How to Change Them&quot; Session 4 - &quot;How to Increase Your&#xD;
      Resilience Through Support from Others&quot; Session 5 - &quot;My Personal Resiliency Plan: Goal&#xD;
      Setting&quot; Session 6 - &quot;Celebrate Your Resiliency: Graduation&quot;&#xD;
&#xD;
      Pilot Post Class Assessment Focus Groups with pilot study participants We will invite all&#xD;
      pilot study participants to participate in one of two post pilot study focus groups of 90&#xD;
      minutes. Focus groups will be conducted by Bowen Chung. All focus groups will be held at&#xD;
      either 1st African Presbyterian Church or Healthy African American Families II and&#xD;
      audio-taped for later transcription and analysis. The goal of these focus groups will be to&#xD;
      see from the pilot participant's perspective: what the experience was like to participate in&#xD;
      the Resiliency Class; what about the class worked well; what aspects of the class needed&#xD;
      improvement; and how they would suggest the class be improved.&#xD;
&#xD;
      Pilot Two month follow-up interview: Two months after the completion of the class, the pilot&#xD;
      participants will be asked to take the follow-up interview mostly to assess the feasibility&#xD;
      and length of time it takes to administer the study instrument. The post-class assessment&#xD;
      will be administered over the phone or in person.&#xD;
&#xD;
      Revisions to Pilot Resiliency Class manual and to study instruments: During class&#xD;
      implementation and after the completion of the pilot, revisions will be made to the manual&#xD;
      and to the study instruments based on feedback from the instructors and the UCLA study&#xD;
      research staff.&#xD;
&#xD;
      Recruiting Additional Agencies for the randomized trial: During phase I, we will also recruit&#xD;
      3 additional agencies for the randomized trial phase of this study.&#xD;
&#xD;
      Phase II - Randomized trial of the Resiliency Class In the randomized trial phase, we expect&#xD;
      to screen 1000 adults for depressive symptoms using the PHQ-2 to obtain about 400 potential&#xD;
      participants for study entry. Our study plans on having between 200 and 300 eligible adults&#xD;
      to consent to participate in a randomized trial of our seven session resiliency class (study&#xD;
      group) versus two case management phone calls (control group). We will assess the resiliency&#xD;
      class's differential impact (versus the case management calls) on study participants'&#xD;
      depressive symptoms (primary outcome measure) as well as other study measures (e.g. SF-12,&#xD;
      substance use, use of health and mental health services, physical activity).&#xD;
&#xD;
      Screening and Recruitment of Randomized Trial Participants UCLA research assistants will&#xD;
      recruit potential participants from community-based agencies. A table with a sign (promoting&#xD;
      the study will be set up at the recruitment site and a study brochure will be distributed to&#xD;
      individuals interested in the study. Research staff will screen potential participants&#xD;
      one-on-one by telephone or in person to determine eligibility. The screening instrument&#xD;
      contains questions on race/ethnicity, age, gender, language, and depressive symptoms. As part&#xD;
      of the screener, we will use the Patient Health Questionnaire 8 (PHQ-8) to assess probable&#xD;
      depression. When the PHQ-8 is administered by phone, it will be done on a one-on-one basis.&#xD;
      It will take no more than 15 minutes to complete the entire screener. Screeners that are&#xD;
      administered in person will be done in a private room at the recruitment site. All measures&#xD;
      will be administered in a private room on a one-to-one basis at the recruitment site.&#xD;
      Potential study participants will be offered a monetary incentive for being screened for the&#xD;
      study as well as a resource guide that lists agencies that provide health care, mental&#xD;
      health, substance use, social services, child welfare services, senior center, and prison&#xD;
      re-entry programs in South Los Angeles.&#xD;
&#xD;
      B-RICH Phase II, Randomized Trial Inclusion Criteria&#xD;
&#xD;
        1. Age 18 or older&#xD;
&#xD;
        2. Endorse one of the first two items on the PHQ-8: &quot;In the past two weeks, how often have&#xD;
           you been bothered by 1) little interest or pleasure in doing things, 2) feeling down&#xD;
           depressed or hopeless.&quot;&#xD;
&#xD;
        3. Able to be contacted by phone (voice or text message), e-mail, or Facebook.&#xD;
&#xD;
        4. Able to participate in the seven, weekly 90-120 minute sessions of the Resiliency&#xD;
           Classes&#xD;
&#xD;
        5. English or Spanish speaker&#xD;
&#xD;
      If score is between 15-19, we will allow them to enroll in the study if they are in existing&#xD;
      treatment. If they are not, we will make a referral and measure their mood throughout the&#xD;
      intervention. If at the end of the class, anyone is still in the range of 15-19 we will&#xD;
      highly recommend that they get treatment and we will make a referral to a local mental health&#xD;
      agency.&#xD;
&#xD;
      Patient Engagement Approach: The class instructor will do some follow-up with participants&#xD;
      who enter the study with a PHQ-8 score of 15-19 to see if they went to the referral agency,&#xD;
      ask if they saw a provider, are they receiving treatment, if not what were their barriers.&#xD;
&#xD;
      The PHQ-8 will be administered during class 1, 4, and 7 and 3-month follow-up of the&#xD;
      intervention to track whether depressive symptoms are improving or worsening.&#xD;
&#xD;
      B-RICH Phase II, Randomized Trial Exclusion Criteria&#xD;
&#xD;
        1. Under age 18 years&#xD;
&#xD;
        2. PHQ-8 score of 20 or greater on the baseline interview&#xD;
&#xD;
        3. PHQ-8 score of 15 or greater and not currently in care and unwilling to get a referral&#xD;
           for care&#xD;
&#xD;
        4. Currently homeless&#xD;
&#xD;
        5. Has a prior diagnosis of Bipolar Disorder&#xD;
&#xD;
        6. Has a prior diagnosis of Schizophrenia&#xD;
&#xD;
        7. Current alcohol and substance abuse&#xD;
&#xD;
        8. Unable to attend the weekly resiliency classes&#xD;
&#xD;
        9. Does not currently have a phone, an email address, or a Facebook profile&#xD;
&#xD;
      Consenting Process: The same consenting process will be used as described in the pilot above.&#xD;
&#xD;
      Baseline Assessments If they agree to participate in the study at the time of screening,&#xD;
      participants will be asked to take part in the 45 minute baseline interview either in person&#xD;
      when the consent has been signed or over the phone at a later time and date. For those who do&#xD;
      not consent at the time of screening but within a week of being screened, the baseline&#xD;
      interview will be administered over the phone. Baseline interview) will be conducted by a&#xD;
      UCLA Research Assistant. Each participant will be offered a monetary incentive for completion&#xD;
      of the baseline interview. Payment will offered in person to those who elect to take the&#xD;
      baseline interview in person. Participants who elect to take the interview over the phone&#xD;
      will have the choice of picking up their incentive payment at the UCLA Center for Health&#xD;
      Services and Society or mailed to them at an address of their choice.&#xD;
&#xD;
      Randomization As part of the Study Recruitment packet, there will be a sealed envelope that&#xD;
      will indicate whether the study participant has been randomized to either the resiliency&#xD;
      class or the case management phone calls. If the enrollment and baseline survey are completed&#xD;
      in person, the study staff that consents and completes the baseline interview with the study&#xD;
      participant will open the envelope to determine which condition the study participant has&#xD;
      been assigned: control or study group. If the baseline interview is conducted over the phone,&#xD;
      the envelope assigning the study participant will be opened by research staff and inform them&#xD;
      of their assignment over the phone.&#xD;
&#xD;
      In order to assure that that research staff are unaware of the intervention condition at&#xD;
      follow-up, we will re-assign study participants to different research staff person to conduct&#xD;
      the 3 month follow-up interview.&#xD;
&#xD;
      Case management social services assessment and referrals (control group) Study participants&#xD;
      randomized to the case management phone calls will be told that they will receive two calls&#xD;
      over two months by study staff to offer them referrals based on their perceived need for&#xD;
      services to local health care, mental health, substance use, social services, child welfare,&#xD;
      housing, and food. In addition, study participants in this arm of the study will be told that&#xD;
      if the study determines that the resiliency classes are better at improving mood than the&#xD;
      case management calls, they will receive a call to invite them to participate in resiliency&#xD;
      classes for free at the B-RICH partner agencies.&#xD;
&#xD;
      Resiliency Classes (study group) Study participant randomized to the Resiliency classes will&#xD;
      be offered and assigned a time and date to attend the classes at Healthy African American&#xD;
      Families II, 1st African Presbyterian Church, Los Angeles Biomedical Research Institute, and&#xD;
      at the additional partner agencies that will be recruited. In order to facilitate their&#xD;
      participation in the class, they will be offered bus tokens for transportation to attend the&#xD;
      first three classes. Each class will have up to 10-12 participants.&#xD;
&#xD;
      The instructors for the class will be a UCLA research study staff member and a staff member&#xD;
      from Healthy African American Families II or the 1st African Presbyterian Church.&#xD;
&#xD;
      Classes will be 90-120 minutes in duration and will be held weekly for seven weeks. At the&#xD;
      classes, participants will be offered a copy of the Resiliency Class Manual. And at each&#xD;
      class, light snacks and refreshments will be offered.&#xD;
&#xD;
      Each class will be audio recorded on a digital audio recorder for review by Bowen Chung and /&#xD;
      or Jeanne Miranda to provide feedback on the instructor's class technique of delivering this&#xD;
      educational intervention. The audio tapes will be uploaded to a HIPAA compliant, password&#xD;
      protected website housed on a secure server at the UCLA Center for Health Services and&#xD;
      Society. After review of the audio taped sessions, the data for these sessions will be&#xD;
      destroyed. These audio recordings will not be used for research purposes, but merely to&#xD;
      assess the instructors' skill and to provide feedback on how to improve teaching the class.&#xD;
&#xD;
      The Resiliency Class manual covers same topics described above.&#xD;
&#xD;
      3 month follow-up interview Participants will be asked to participate by phone in a 45 minute&#xD;
      follow-up interview 3 months after being enrolled in the study.&#xD;
&#xD;
      Data Analysis&#xD;
&#xD;
      Phase I Quantitative analysis: Descriptive analysis will be conducted using our screener&#xD;
      measures. Univariate distributions will be examined to identify outliers and assess their&#xD;
      influence on the analyses. Issues to be considered include errors in data input, scoring or&#xD;
      other sources of invalidity in the measurements. The data will be carefully inspected to&#xD;
      determine the need for scale transformations and to identify missing data, outliers, or other&#xD;
      unusual features. Assumptions of normality will also be evaluated. Change scores in&#xD;
      depressive symptoms from baseline to post-class interviews will be assessed by 95% confidence&#xD;
      intervals. Due to small sample size (n=20) in this pilot phase, no formal testing hypotheses&#xD;
      will be conducted.&#xD;
&#xD;
      Qualitative / Focus Group data: Qualitative materials will be transcribed by a confidential&#xD;
      transcriber and de-identified by a confidential research assistant. The research assistant&#xD;
      will transform field code identifiers into analytic code identifiers and maintain the code&#xD;
      list in a secure file. Each dataset - discussion notes, recorded feedback, and interview&#xD;
      responses - will be entered into a file in the project Dedoose file (www.dedoose.com), a&#xD;
      password-protected online site, using the UCLA Dedoose program (www.dedoose.com), software&#xD;
      designed specifically to facilitate mixed-methods analysis. We will then use constructive&#xD;
      grounded theory analysis to develop coding categories based on the themes embedded in the&#xD;
      datasets that fall within domains of interest. (12) In particular, we will be examining the&#xD;
      qualitative data for themes describing: 1) what their experiences were like with the&#xD;
      resiliency class; 2) what aspects of the resiliency class worked to improve their mood; 3)&#xD;
      what aspects of the resiliency class did not improve their mood; 4) what they felt needed to&#xD;
      be improved about the resiliency class and the manual; 5) how they suggest improving the&#xD;
      resiliency class and manual.&#xD;
&#xD;
      Phase II Analysis of Baseline and 3 month follow-up interview data The main analyses will be&#xD;
      intent-to-treat comparing main effects of CBT intervention versus case management calls&#xD;
      control. We hypothesizes that CBT class will have a greater impact on reducing depressive&#xD;
      symptoms (PHQ-8) than control. We will also examine the intervention effects on other study&#xD;
      measures (e.g. MCS-12, PCS12, substance use, use of health and mental health services). We&#xD;
      will use an ANCOVA model that specifies the outcome measure observed at the 3 months as the&#xD;
      dependent variable (e.g. PHQ-8), treatment group as the independent variable, controlled for&#xD;
      the baseline measure for the same outcome as the covariate. For binary outcomes (e.g.&#xD;
      substance use or prior use of antidepressant medication) we will fit a logistic regression&#xD;
      model.&#xD;
&#xD;
      General Analytic Strategies Univariate distributions will be examined to identify outliers&#xD;
      and assess their influence on the analyses. Issues to be considered include errors in data&#xD;
      input, scoring or other sources of invalidity in the measurements. The data will be carefully&#xD;
      inspected to determine the need for scale transformations and to identify missing data,&#xD;
      outliers, or other unusual features. To improve the precision of the estimated intervention&#xD;
      effect, we will conduct a series of bivariate analyses to identify the potential covariates&#xD;
      to be considered for a multiple regression model. Confounding will be assessed by comparing&#xD;
      the unadjusted coefficient for treatment condition with the adjusted coefficient. Assumptions&#xD;
      of normality will also be evaluated. For example, we will explore various transformations&#xD;
      (e.g., log) for number of visits due to the often skewed distribution of event counts.&#xD;
      Smearing estimates will be used, if necessary, for retransformation, applying separate&#xD;
      factors for each intervention group to ensure consistent estimates (13) In general, we leave&#xD;
      open the possibility of transforming variables with non-normal distributions (14) In certain&#xD;
      cases, the outcome of interest will have a skewed distribution, either because there will be&#xD;
      many zeros (e.g. days of work missed due to illness) and/or because the distribution of&#xD;
      observed values has a very long tail (e.g. services utilization). In such cases, we will draw&#xD;
      upon statistical models developed for these type of data, in particular a two-part model to&#xD;
      separately handle zero values and a skewed distribution among non-zeros (13). Tobit-type&#xD;
      sample selection models (15); split-sample techniques to distinguish between different&#xD;
      functional forms and to avoid overfitting (13); and dynamic models, such as episodes of care&#xD;
      analytic models, duration analysis, and count models (16).&#xD;
&#xD;
      To improve the precision of the estimated intervention effect, we will conduct a series of&#xD;
      bivariate analyses to identify the potential covariates to be considered for a multiple&#xD;
      regression model. Confounding will be assessed by comparing the unadjusted coefficient for&#xD;
      treatment condition with the adjusted coefficient. We will consider multiple imputation to&#xD;
      account for unit level non-response (17) We will inspect patterns of missing data. If&#xD;
      non-response appears to be non-ignorable we will employ statistical techniques such as&#xD;
      pattern mixture models and related methods ; and otherwise imputation strategies will assume&#xD;
      that non-response is ignorable (i.e. missing at random). (13, 17-19)&#xD;
&#xD;
      Description of measures B-RICH PARTICIPANT STUDY SCREENER Age PHQ-2 Whether they know&#xD;
      provider or staff member they see at agency&#xD;
&#xD;
      BASELINE INTERVIEW Health status Gender Marital status Children under age 18 living at home&#xD;
      Health Insurance coverage Education Employment Born in the U.S. Ethnicity Housing PHQ-8&#xD;
      Function: SF-12 Fordyce Emotions Questionnaire Brief Resiliency Scale Use of Services&#xD;
      (health, mental health, substance use, social services, religious, parks and recreation)&#xD;
      Current Medication Use Satisfaction with Services Beliefs about people with depression&#xD;
      Beliefs about treating depression Chronic Conditions (medical, smoking, weight, height,&#xD;
      physical activity) Current and Past Use of Alcohol / Drugs Life Difficulties in Past 6 months&#xD;
      Coping Strategies Social Supports Employment, work missed for those employed Income Income,&#xD;
      income from governmental sources Food security&#xD;
&#xD;
      3 MONTH FOLLOW-UP INTERVIEW Demographics Date of birth Marital status Housing PHQ-8 Function:&#xD;
      SF-12 Fordyce Emotions Questionnaire Brief Resiliency Scale Use of Services (health, mental&#xD;
      health, substance use, social services, religious, parks and recreation) Current Use&#xD;
      Medications Beliefs about people with depression Beliefs about treating depression Chronic&#xD;
      Conditions (medical, smoking, weight, height, physical activity) Current and Past Use of&#xD;
      Alcohol / Drugs Life Difficulties in Past 6 months Coping Strategies Social Supports&#xD;
      Employment, work missed for those employed Income, income from governmental sources Food&#xD;
      security&#xD;
&#xD;
      Phase II RCT:&#xD;
&#xD;
      All data collection was completed in 2014. Study participants were screened (n=310) and&#xD;
      enrolled (n=168) from community-based organizations located in South Los Angeles including a&#xD;
      Women, Infants, and Children (WIC) program; a senior center; a church; a faith-based,&#xD;
      low-income senior housing facility; a health advocacy organization, a YMCA, and a federally&#xD;
      qualified health center. 84 participants were randomized into the case management assessment&#xD;
      and referral arm and 84 into the resiliency class intervention.&#xD;
&#xD;
      Data analyses are currently under way and we are preparing a manuscript with the findings for&#xD;
      publication in the next several months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive symptom count as measured by the Patient Health Questionnaire 8</measure>
    <time_frame>Change from Baseline in Depressive Symptoms at 3 months</time_frame>
    <description>The Patient Health Questionnaire (PHQ) 8 is a standard measure of depressive symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mental health related quality of life (MCS-12) from the Short Form 12 item - Health Survey</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Mental health related quality of life from the mental component of the Short Form 12-item Health Survey (SF-12). The SF-12 is a multipurpose short-form (SF) generic measure of health status. The 12 items in the SF-12 are a subset of those in the SF-36. SF-12 includes on or items from each of the eight health concepts. Therefore, the SF-12 measures eight concepts of health status: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well being). The first four health concepts indicate physical health status and the others indicate mental health status.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Client Use of Services</measure>
    <time_frame>Baseline, 3 month</time_frame>
    <description>The client use of services Scale is a 49 item measure that assesses access to and use of general health services in the community. This includes hospitalizations, ER visits, Mental Health Services, Substance Abuse Services, Social and Community-based Services, and other trusted locations.</description>
  </other_outcome>
  <other_outcome>
    <measure>Current Medication Use</measure>
    <time_frame>Baseline, 3 month</time_frame>
    <description>The current medication use is a measure with 3 items created to identify any prescribed medications being consumed for mental or emotional problems such as depression, anxiety, or nerves.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction with Community Services</measure>
    <time_frame>Baseline, 3 month</time_frame>
    <description>The satisfaction with community services is a measure with 5 items (1-very dissatisfied to 5- very satisfied) used to assess the satisfaction of the availability of health and social services in community.</description>
  </other_outcome>
  <other_outcome>
    <measure>Chronic Conditions</measure>
    <time_frame>Baseline, 3 month</time_frame>
    <description>The chronic condition is a standard measure of health problems some people may have (medical, smoking, weight, height, physical activity). There are 23 items in this measure.</description>
  </other_outcome>
  <other_outcome>
    <measure>Current and Past Use of Alcohol / Drugs</measure>
    <time_frame>Baseline, 3 month</time_frame>
    <description>The current and past use of alcohol or drugs is a measure with 13 items created to assess the use of illicit drugs or alcohol abuse.</description>
  </other_outcome>
  <other_outcome>
    <measure>Life Difficulties in Past 3 months</measure>
    <time_frame>Baseline, 3 month</time_frame>
    <description>The life difficulties during the past six months is a 15 item measure created to identify life stress events.</description>
  </other_outcome>
  <other_outcome>
    <measure>Coping Strategies</measure>
    <time_frame>Baseline, 3 month</time_frame>
    <description>The coping strategies questionnaire is a 4 item measure used to determine any use of avoidant and/or active coping strategies to stressful situations or problems.</description>
  </other_outcome>
  <other_outcome>
    <measure>Social Supports</measure>
    <time_frame>Baseline, 3 month</time_frame>
    <description>The social support survey is a 10 item measure created to help assess various dimensions of social support (emotional, affectionate, and positive social interaction).</description>
  </other_outcome>
  <other_outcome>
    <measure>Employment, work missed for those employed</measure>
    <time_frame>Baseline, 3 month</time_frame>
    <description>The employment questionnaire has 18 items that assesses the employment situation of participants. There are 4 additional items reporting any days missed of work.</description>
  </other_outcome>
  <other_outcome>
    <measure>Income</measure>
    <time_frame>Baseline, 3 month</time_frame>
    <description>The income survey is a 16 item measure created to evaluate the level of income within each household and whether families received income from any government programs.</description>
  </other_outcome>
  <other_outcome>
    <measure>Food Security</measure>
    <time_frame>Baseline, 3 month</time_frame>
    <description>The food security is a 2 item measure created to determine household food security .</description>
  </other_outcome>
  <other_outcome>
    <measure>Fordyce Emotions Questionnaire</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>This questionnaire assesses current happiness with four questions. The first question assesses current happiness on a scale of 0 (extremely unhappy) to 10 (extremely happy). Questions 2 through 4 asks the percent of time the respondent feels happy; percent of time unhappy; and percent of time neutral.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>Resiliency Class</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resiliency Classes (study group) Study participant randomized to the Resiliency classes will be offered and assigned a time and date to attend the classes. Each class will have up to 10 participants. Classes will be 90-120 minutes in duration and will be held weekly for six weeks. At the classes, participants will be offered a copy of the Resiliency Class Manual. And at each class, light snacks and refreshments will be offered.&#xD;
The Resiliency Class manual covers the following topics:&#xD;
Session 1 - &quot;What Affects Your Mood and Resilience;&quot; Session 2 - &quot;Pleasant Activities Can Help Improve Your Mood and Make You Resilient;&quot; Session 3 - &quot;What Gets In The Way of Pleasant Activities: Harmful Thoughts and How to Change Them;&quot; Session 4 - &quot;How to Increase Your Resilience Through Support from Others;&quot; Session 5 - &quot;My Personal Resiliency Plan: Goal Setting;&quot; Session 6 - &quot;Celebrate Your Resiliency: Graduation&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Case Management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Case management phone calls (control group) Study participants randomized to the case management phone calls will be told that they will receive two calls over two months by study staff to offer them referrals based on their perceived need for services to local health care, mental health, substance use, social services, child welfare, housing, and food. In addition, study participants in this arm of the study will be told that if the study determines that the resiliency classes are better at improving mood than the case management calls, they will receive a call to invite them to participate in resiliency classes for free at the B-RICH partner agencies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resiliency Class</intervention_name>
    <description>See Arm Description</description>
    <arm_group_label>Resiliency Class</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Case Management</intervention_name>
    <description>See Case Management description</description>
    <arm_group_label>Case Management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        B-RICH Phase I, Pilot Inclusion Criteria&#xD;
&#xD;
          1. Age 18 or older&#xD;
&#xD;
          2. Endorse one item on the PHQ-2&#xD;
&#xD;
          3. Able to be contacted by phone&#xD;
&#xD;
          4. Able to participate in the six, weekly 90-120 minute sessions of the Resiliency&#xD;
             Classes&#xD;
&#xD;
          5. English or Spanish speaker&#xD;
&#xD;
        B-RICH, Phase I Pilot Exclusion Criteria&#xD;
&#xD;
          1. Under age 18 years&#xD;
&#xD;
          2. Endorse no items on PHQ-2 screener&#xD;
&#xD;
          3. PHQ-8 score of 15 or greater on the baseline interview&#xD;
&#xD;
        3) Unable to be contacted by phone 4) Unable to attend the weekly resiliency classes&#xD;
&#xD;
        B-RICH Phase II, Randomized Trial Inclusion Criteria&#xD;
&#xD;
          1. Age 18 or older&#xD;
&#xD;
          2. Endorse one of the first two items on the PHQ-8: &quot;In the past two weeks, how often&#xD;
             have you been bothered by 1) little interest or pleasure in doing things, 2) feeling&#xD;
             down depressed or hopeless.&quot;&#xD;
&#xD;
          3. Able to be contacted by phone (voice or text message), e-mail, or Facebook.&#xD;
&#xD;
          4. Able to participate in the seven, weekly 90-120 minute sessions of the Resiliency&#xD;
             Classes&#xD;
&#xD;
          5. English or Spanish speaker&#xD;
&#xD;
        B-RICH Phase II, Randomized Trial Exclusion Criteria&#xD;
&#xD;
          1. Under age 18 years&#xD;
&#xD;
          2. PHQ-8 score of 20 or greater on the baseline interview&#xD;
&#xD;
          3. PHQ-8 score of 15 or greater and not currently in care and unwilling to get a referral&#xD;
             for care&#xD;
&#xD;
          4. Currently homeless&#xD;
&#xD;
          5. Has a prior diagnosis of Bipolar Disorder&#xD;
&#xD;
          6. Has a prior diagnosis of Schizophrenia&#xD;
&#xD;
          7. Current alcohol and substance abuse&#xD;
&#xD;
          8. Unable to attend the weekly resiliency classes&#xD;
&#xD;
          9. Does not currently have a phone, an email address, or a Facebook profile&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bowen Chung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Healthy African American Families</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1st African Presbyterian Church</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles Biomedical Research Institute</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>May 4, 2017</last_update_submitted>
  <last_update_submitted_qc>May 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Bowen Chung, MD, MSHS</investigator_full_name>
    <investigator_title>Associate Professor-in-Residence</investigator_title>
  </responsible_party>
  <keyword>Depressive symptoms</keyword>
  <keyword>sub-threshold depression</keyword>
  <keyword>resiliency</keyword>
  <keyword>Health Promotion</keyword>
  <keyword>minority health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There are no current plans to share a de-identified, individual participant data as a publicly available dataset due to the original funding not including resources to support this activity; however on a case-by-case basis, the PI would consider additional analyses of the data by other investigators.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01698047
org study id: CCF-12-001142
secondary id: CMCH 12-97088
nct id: NCT01698047
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to build a scientific evidence base for the training and
      delivery of a depressive symptoms education program, developed by local community members,
      called a Resiliency Class (RC). The RC has strong elements of Cognitive Behavioral Therapy
      and is designed to be delivered as a psycho-educational class by non-professionals to improve
      mood. Depressive symptoms are common, especially in low-income, minority communities.
      Depressive symptoms that don't meet DSM-IV criteria for Major Depression still carry a
      significant amount of disability. Interventions that address sub-threshold depressive
      symptoms have been noted to result in a decreased likelihood of depression and diminished use
      of mental health services. Few interventions using a health education / health promotion
      focus are designed to be delivered by non-professionals to address individuals with mild to
      moderate depressive symptoms in low income, minority communities. This project will take
      place in the Centinela Valley, which roughly corresponds to Service Planning Area (SPA) 6 or
      South Los Angeles (SLA). This single-blind, randomized trial will utilize a wait-list control
      design where half of the participants enrolled in the study will be randomized to the
      Resiliency Class (7 sessions) and half will go to a wait-list control condition where they
      will receive 2 case management calls and referrals to social services. We propose to screen
      1500 clients to detect about 450 participants with depressive symptoms (endorsed one item on
      the PHQ-2). We plan to enroll 400 participants, 200 in the resiliency class and 200 in the
      wait-list control condition. Primary outcomes measures will include depressive symptoms,
      function, and measures of resiliency. We will assess these measures at baseline and at 3
      months after completion of the Resiliency Class or wait-list condition. After the completion
      of the first round of classes, we will conduct a preliminary analysis of the impact of the
      resiliency classes versus the wait-list control case management calls on depressive symptoms.
      If the resiliency classes improve depressive symptoms more than the wait-list control, we
      will offer wait-list controls access to the resiliency classes and then disseminate the
      resiliency class through trainings.

      We hypothesize that the resiliency classes will lead to greater reductions in client
      depressive symptoms than the wait-list case management calls in the randomized trial of this
      project.
B-RICH proposes to pilot and then conduct a randomized, single blind trial of a psychosocial
      intervention called a "Resiliency Class" (RC), to provide depression education and health
      promotion to individuals with depressive symptoms, by training non-professionals to offer
      this class to clients receiving services within diverse community settings (e.g. health care
      clinic, church, community advocacy organization, social services agency). This class is not
      designed to be therapy, but rather is designed as a class that is informed on cognitive
      behavioral therapy (CBT) principles used to address depressive symptoms, on how to improve
      mood, and to enhance resiliency in the face of stress.

      The Resiliency Class is a manualized, CBT informed, seven session, psycho-educational
      intervention designed to be delivered by non-licensed teachers in both English and Spanish to
      address depressive symptoms. Each session is designed to be between 90-120 minutes. Some of
      the goals of the RC are: 1) to provide psycho-education on mood and depressive symptoms; 2)
      to provide this education through teachers who are not health or mental healthcare
      professionals in order to improve access to depression education and to offer approaches to
      improve depressive symptoms; 3) to deliver this class in non-health care or mental health
      care settings like churches or in trusted community locations (e.g. parks and recreation,
      primary care, social services agencies, job retraining centers, senior centers) instead of as
      "therapy" or in mental health settings so that individuals would not feel stigmatized; 4) to
      design the manual so that it will be usable by class participants with low literacy levels in
      both English and Spanish.

      The specific aims for this study are to:

        1. Pilot a revised resiliency class intervention led by non-professionals in 20 individuals
           with depressive symptoms for acceptability;

        2. Revise the resiliency class intervention based on therapist's experience from the pilot
           based on feedback from both the instructors and the pilot class participants;

        3. Conduct a randomized, single blind trial of the resiliency class (study group) versus
           case management social services assessment and referrals (control group) to assess their
           differential impact on depressive symptoms in 400 study participants (200 in each arm of
           the study).

      There will be several steps to the implementation of the B-RICH Study. Phase I

        1. We will conduct a pilot of the Resiliency Class Manual with 2 instructors and 20
           individuals divided in two classes in the fall of 2012. We will screen 100 clients at
           Healthy African American Families II and the 1st African Presbyterian Church located in
           South Los Angeles to detect approximately 70 potential participants with depressive
           symptoms using the Patient Health Questionnaire 2 (PHQ-2). Participants who endorse one
           item on the PHQ-2, are 18 years or older, can attend six 90-120 minute weekly Resiliency
           Classes, and have a PHQ-8 score less than 15 (on the baseline interview) will be
           eligible to enroll in the Resiliency Class. These classes will be delivered by a
           non-licensed, individual who would be the equivalent of a community health worker. The
           classes will be supervised by Bowen Chung and Jeanne Miranda. In this phase of the
           study, we will pilot the participant screener, baseline interview, and follow-up
           interview for feasibility and to assess the amount of time each instrument will require.

        2. Based on the class instructor's feedback and focus groups with the pilot class study
           participants, the PI, Co-PI, and project manager will then re-revise the manual for a
           final version which will be utilized in the randomized trial of the resiliency class
           (study group) versus 2 case management calls (control group) that will be started in
           January 2013.

      Phase II 4) We will conduct a randomized trial of the Resiliency Class (study group) compared
      to telephone case management social services assessment (control group) and referrals,to
      ascertain their differential impact on depressive symptoms between January 2013 and January
      2014.

      4a) We will screen 1000 clients at the partner agencies for potential study participation.
      Entry criteria will include those individuals age 18 or older who endorse at least one item
      on the Patient Health Questionnaire- 2 (PHQ-2), have a reliable way to contact them by phone,
      and are able to attend our six, weekly sessions of the Resiliency Class. We estimate that
      screening will take place between January 2013 and June 2013.

      4b) We plan on enrolling 400 clients into the study. 4c) Enrolled participants will then be
      offered a 45 minute baseline interview, that will collect data on income, housing, functional
      status (short form health survey - 12 item or SF-12); medical conditions; mental health
      conditions; alcohol and substance use; use of health and mental health services; knowledge,
      attitudes, and beliefs about depression; housing; food insecurity; coping strategies;
      medication use; satisfaction with services; and health insurance status. We will also collect
      contact information as well as information about 3 people who will always know how to reach
      the participant in case their direct contact information becomes invalid due to a
      disconnected phone or a change in address. The baseline interview will be conducted at the
      time of recruitment in the community at study agencies after determining study eligibility or
      on the phone either on a laptop computer or using pencil and paper by a study research
      assistant. We will exclude enrolled participants with a PHQ-8 score of 20 or greater (severe
      depression) and refer them to local mental health agencies in the area.

      4d) After being enrolled in the study and completing the baseline interview, participants
      will either be randomized to the control group (two case management phone calls) or to the
      study group (a seven session resiliency class).

      4e) Participants randomized to the control group will receive two calls from a case manager
      of the participating partner agencies within the first two months of their enrollment. These
      phone calls will ask the study participants if they should need referrals in the local
      community for healthcare, mental health care, substance use, job retraining, and social
      services. If the participants are in need of referrals, they will be offered a phone number
      and address for an agency that will meet their needs.

      4f) Participants randomized to the study group will then be offered enrollment in a
      Resiliency Class that will take place at the agency they were screened at.

      4g) The study group will have staggered starting times that will depend on success of
      participant enrollment. Each weekly, 90-120 minute class will have 10-12 study participants.
      Each participant in the Resiliency Class will receive a copy of the study manual at the
      initial class. In addition, the class instructor will provide light snacks and refreshments
      to participants at each class. Class instructors will be a combination of study staff as well
      as staff from partner agencies.

      4h) Study Participants in both arms of the study will receive a 3-month, telephone follow-up
      interview assessing measures on the baseline interview that should take about 45 minutes.

      4i) Research staff interviewing participants in baseline and follow-up interviews will be
      blinded as to the intervention status of the study participants.

      5) We will conduct data analysis on the primary outcome measures, depressive symptoms as
      assessed by the PHQ-8. If the Resiliency Class shows a greater impact on diminishing
      depressive symptoms, the primary study outcome measure, than the case management phone calls,
      we will contact all participants in the case management arm of the study and offer the
      resiliency classes to those participants free of charge, as well as offer training to all
      staff from agencies interested in implementing the resiliency class intervention.

      Phase I: Resiliency Class Pilot Intervention The goal of this step of the study is to pilot
      the Resiliency Class in order to assess for feasibility and to determine if the intervention
      might need additional changes to improve delivery of the intervention from the perspective of
      the class instructors.

      Screening and Recruitment of Pilot Participants Study research assistants will use the
      screening script in to recruit potential participants at the pilot sites: Healthy African
      American Families II and the 1st African Presbyterian Church. A table with a sign promoting
      the study will be set up at the recruitment site and a study brochure will be distributed to
      individuals interested in the study. Research staff will then obtain oral consent and screen
      potential participants one-on-one by telephone or in person to determine eligibility. The
      screening instrument contains questions on race/ethnicity, age, gender, language, and
      depressive symptoms. As part of the screener, we will use the PHQ-2 to assess probable
      depression. It will take no more than 10 minutes to complete the entire screener. Screeners
      that are administered in person will be done in a private room at the recruitment site. All
      measures will be administered in a private room on a one-to-one basis at the recruitment
      site. Potential study participants will be offered a monetary incentive for being screened
      for the study as well as a resource guide that lists agencies that provide health care,
      mental health, substance use, social services, child welfare services, and prison re-entry
      programs in South Los Angeles.

      B-RICH Phase I, Pilot Inclusion Criteria

        1. Age 18 or older

        2. Endorse one item on the PHQ-2

        3. Able to be contacted by phone

        4. Able to participate in the six, weekly 90-120 minute sessions of the Resiliency Classes

        5. English or Spanish speaker

      B-RICH, Phase I Pilot Exclusion Criteria

        1. Under age 18 years

        2. Endorse no items on PHQ-2 screener

        3. PHQ-8 score of 15 or greater on the baseline interview

      3) Unable to be contacted by phone 4) Unable to attend the weekly resiliency classes

      Pilot Consenting Process If participants are eligible for the study, the UCLA research
      assistant will offer the participant the IRB approved Pilot Non-Randomized consent form at
      the time of screening and will explain the full study procedures to the potential study
      participant. UCLA Research assistants will explain the IRB-approved consent and assure that
      the participant will have enough time to read and review the consents before signing. The
      potential participant will be informed verbally in the consent form, that the study involves
      baseline and follow-up interviews, as well as a manualized class that will teach the
      participant how to improve their mood, and that this class will be audio tape recorded for
      review by Bowen Chung and / or Jeanne Miranda to assess the instructors' skill and to provide
      feedback on how to improve teaching the class.

      The research assistants will determine each potential participant's level of comprehension of
      the material presented by asking the participants to summarize in their own words how they
      understand the study procedures, what will be required of them, potential risks and benefits
      of study participation, the voluntary nature of the study, and their right to withdraw at any
      time. They will be encouraged to ask questions about the study, study procedures, as well as
      interviews. Potential participants will be allowed to consent at the initial visit or they
      will offered up to one week to consider their participation and to either mail or fax their
      consent form back to the UCLA research assistant so that they will have an opportunity to
      think about study participation and / or discuss potential study participation with family
      members or friends. All study participants will understand that their acceptance or refusal
      to participate in the study will in no way affect their ability to receive services or care
      at the agency they were screened at or any other B-RICH partner agency. In addition, they
      will be informed that they will be able to withdraw their consent and discontinue study
      participation at any time without any adverse consequences. If the potential participant has
      any questions, they can call and request to meet with the study investigators and the project
      manager at any time.

      Pilot Baseline Assessments If they agree to participate in the study, participants will be
      asked to take part in the 45 minute baseline interview either in person when the consent has
      been signed or over the phone at a later time and date. Baseline interview will be conducted
      by a UCLA Research Assistant.

      Pilot Resiliency Class After completion of the interview, the participant will be offered and
      assigned a time and date to attend the classes at either Healthy African American Families II
      or at the 1st African Presbyterian Church. In order to facilitate their participation in the
      class, they will be offered bus tokens for transportation to attend the first three classes.
      Each class will have up to 10 participants.

      The instructors for the class will be a UCLA research study staff member and a staff member
      from Healthy African American Families II or the 1st African Presbyterian Church.

      Classes will be 90-120 minutes in duration and will be held weekly for six weeks. At the
      classes, participants will be offered a copy of the Resiliency Class Manual. And at each
      class, light snacks and refreshments will be offered.

      Each class will be audio recorded on a digital audio recorder for review by Bowen Chung and /
      or Jeanne Miranda to provide feedback on the class instructor's technique of delivering this
      educational intervention. The audio tapes will be uploaded to a HIPAA compliant, password
      protected website housed on a secure server at the UCLA Center for Health Services and
      Society. After review of the audio taped sessions, the data for these sessions will be
      destroyed. These audio recordings will not be used for research purposes, but merely to
      assess the instructor's skill and to provide feedback on how to improve teaching the class.

      The Pilot Resiliency Class manual covers the following topics:

      Session 1 - "What Affects Your Mood and Resilience" Session 2 - "Pleasant Activities Can Help
      Improve Your Mood and Make You Resilient" Session 3 - "What Gets In The Way of Pleasant
      Activities: Harmful Thoughts and How to Change Them" Session 4 - "How to Increase Your
      Resilience Through Support from Others" Session 5 - "My Personal Resiliency Plan: Goal
      Setting" Session 6 - "Celebrate Your Resiliency: Graduation"

      Pilot Post Class Assessment Focus Groups with pilot study participants We will invite all
      pilot study participants to participate in one of two post pilot study focus groups of 90
      minutes. Focus groups will be conducted by Bowen Chung. All focus groups will be held at
      either 1st African Presbyterian Church or Healthy African American Families II and
      audio-taped for later transcription and analysis. The goal of these focus groups will be to
      see from the pilot participant's perspective: what the experience was like to participate in
      the Resiliency Class; what about the class worked well; what aspects of the class needed
      improvement; and how they would suggest the class be improved.

      Pilot Two month follow-up interview: Two months after the completion of the class, the pilot
      participants will be asked to take the follow-up interview mostly to assess the feasibility
      and length of time it takes to administer the study instrument. The post-class assessment
      will be administered over the phone or in person.

      Revisions to Pilot Resiliency Class manual and to study instruments: During class
      implementation and after the completion of the pilot, revisions will be made to the manual
      and to the study instruments based on feedback from the instructors and the UCLA study
      research staff.

      Recruiting Additional Agencies for the randomized trial: During phase I, we will also recruit
      3 additional agencies for the randomized trial phase of this study.

      Phase II - Randomized trial of the Resiliency Class In the randomized trial phase, we expect
      to screen 1000 adults for depressive symptoms using the PHQ-2 to obtain about 400 potential
      participants for study entry. Our study plans on having between 200 and 300 eligible adults
      to consent to participate in a randomized trial of our seven session resiliency class (study
      group) versus two case management phone calls (control group). We will assess the resiliency
      class's differential impact (versus the case management calls) on study participants'
      depressive symptoms (primary outcome measure) as well as other study measures (e.g. SF-12,
      substance use, use of health and mental health services, physical activity).

      Screening and Recruitment of Randomized Trial Participants UCLA research assistants will
      recruit potential participants from community-based agencies. A table with a sign (promoting
      the study will be set up at the recruitment site and a study brochure will be distributed to
      individuals interested in the study. Research staff will screen potential participants
      one-on-one by telephone or in person to determine eligibility. The screening instrument
      contains questions on race/ethnicity, age, gender, language, and depressive symptoms. As part
      of the screener, we will use the Patient Health Questionnaire 8 (PHQ-8) to assess probable
      depression. When the PHQ-8 is administered by phone, it will be done on a one-on-one basis.
      It will take no more than 15 minutes to complete the entire screener. Screeners that are
      administered in person will be done in a private room at the recruitment site. All measures
      will be administered in a private room on a one-to-one basis at the recruitment site.
      Potential study participants will be offered a monetary incentive for being screened for the
      study as well as a resource guide that lists agencies that provide health care, mental
      health, substance use, social services, child welfare services, senior center, and prison
      re-entry programs in South Los Angeles.

      B-RICH Phase II, Randomized Trial Inclusion Criteria

        1. Age 18 or older

        2. Endorse one of the first two items on the PHQ-8: "In the past two weeks, how often have
           you been bothered by 1) little interest or pleasure in doing things, 2) feeling down
           depressed or hopeless."

        3. Able to be contacted by phone (voice or text message), e-mail, or Facebook.

        4. Able to participate in the seven, weekly 90-120 minute sessions of the Resiliency
           Classes

        5. English or Spanish speaker

      If score is between 15-19, we will allow them to enroll in the study if they are in existing
      treatment. If they are not, we will make a referral and measure their mood throughout the
      intervention. If at the end of the class, anyone is still in the range of 15-19 we will
      highly recommend that they get treatment and we will make a referral to a local mental health
      agency.

      Patient Engagement Approach: The class instructor will do some follow-up with participants
      who enter the study with a PHQ-8 score of 15-19 to see if they went to the referral agency,
      ask if they saw a provider, are they receiving treatment, if not what were their barriers.

      The PHQ-8 will be administered during class 1, 4, and 7 and 3-month follow-up of the
      intervention to track whether depressive symptoms are improving or worsening.

      B-RICH Phase II, Randomized Trial Exclusion Criteria

        1. Under age 18 years

        2. PHQ-8 score of 20 or greater on the baseline interview

        3. PHQ-8 score of 15 or greater and not currently in care and unwilling to get a referral
           for care

        4. Currently homeless

        5. Has a prior diagnosis of Bipolar Disorder

        6. Has a prior diagnosis of Schizophrenia

        7. Current alcohol and substance abuse

        8. Unable to attend the weekly resiliency classes

        9. Does not currently have a phone, an email address, or a Facebook profile

      Consenting Process: The same consenting process will be used as described in the pilot above.

      Baseline Assessments If they agree to participate in the study at the time of screening,
      participants will be asked to take part in the 45 minute baseline interview either in person
      when the consent has been signed or over the phone at a later time and date. For those who do
      not consent at the time of screening but within a week of being screened, the baseline
      interview will be administered over the phone. Baseline interview) will be conducted by a
      UCLA Research Assistant. Each participant will be offered a monetary incentive for completion
      of the baseline interview. Payment will offered in person to those who elect to take the
      baseline interview in person. Participants who elect to take the interview over the phone
      will have the choice of picking up their incentive payment at the UCLA Center for Health
      Services and Society or mailed to them at an address of their choice.

      Randomization As part of the Study Recruitment packet, there will be a sealed envelope that
      will indicate whether the study participant has been randomized to either the resiliency
      class or the case management phone calls. If the enrollment and baseline survey are completed
      in person, the study staff that consents and completes the baseline interview with the study
      participant will open the envelope to determine which condition the study participant has
      been assigned: control or study group. If the baseline interview is conducted over the phone,
      the envelope assigning the study participant will be opened by research staff and inform them
      of their assignment over the phone.

      In order to assure that that research staff are unaware of the intervention condition at
      follow-up, we will re-assign study participants to different research staff person to conduct
      the 3 month follow-up interview.

      Case management social services assessment and referrals (control group) Study participants
      randomized to the case management phone calls will be told that they will receive two calls
      over two months by study staff to offer them referrals based on their perceived need for
      services to local health care, mental health, substance use, social services, child welfare,
      housing, and food. In addition, study participants in this arm of the study will be told that
      if the study determines that the resiliency classes are better at improving mood than the
      case management calls, they will receive a call to invite them to participate in resiliency
      classes for free at the B-RICH partner agencies.

      Resiliency Classes (study group) Study participant randomized to the Resiliency classes will
      be offered and assigned a time and date to attend the classes at Healthy African American
      Families II, 1st African Presbyterian Church, Los Angeles Biomedical Research Institute, and
      at the additional partner agencies that will be recruited. In order to facilitate their
      participation in the class, they will be offered bus tokens for transportation to attend the
      first three classes. Each class will have up to 10-12 participants.

      The instructors for the class will be a UCLA research study staff member and a staff member
      from Healthy African American Families II or the 1st African Presbyterian Church.

      Classes will be 90-120 minutes in duration and will be held weekly for seven weeks. At the
      classes, participants will be offered a copy of the Resiliency Class Manual. And at each
      class, light snacks and refreshments will be offered.

      Each class will be audio recorded on a digital audio recorder for review by Bowen Chung and /
      or Jeanne Miranda to provide feedback on the instructor's class technique of delivering this
      educational intervention. The audio tapes will be uploaded to a HIPAA compliant, password
      protected website housed on a secure server at the UCLA Center for Health Services and
      Society. After review of the audio taped sessions, the data for these sessions will be
      destroyed. These audio recordings will not be used for research purposes, but merely to
      assess the instructors' skill and to provide feedback on how to improve teaching the class.

      The Resiliency Class manual covers same topics described above.

      3 month follow-up interview Participants will be asked to participate by phone in a 45 minute
      follow-up interview 3 months after being enrolled in the study.

      Data Analysis

      Phase I Quantitative analysis: Descriptive analysis will be conducted using our screener
      measures. Univariate distributions will be examined to identify outliers and assess their
      influence on the analyses. Issues to be considered include errors in data input, scoring or
      other sources of invalidity in the measurements. The data will be carefully inspected to
      determine the need for scale transformations and to identify missing data, outliers, or other
      unusual features. Assumptions of normality will also be evaluated. Change scores in
      depressive symptoms from baseline to post-class interviews will be assessed by 95% confidence
      intervals. Due to small sample size (n=20) in this pilot phase, no formal testing hypotheses
      will be conducted.

      Qualitative / Focus Group data: Qualitative materials will be transcribed by a confidential
      transcriber and de-identified by a confidential research assistant. The research assistant
      will transform field code identifiers into analytic code identifiers and maintain the code
      list in a secure file. Each dataset - discussion notes, recorded feedback, and interview
      responses - will be entered into a file in the project Dedoose file (www.dedoose.com), a
      password-protected online site, using the UCLA Dedoose program (www.dedoose.com), software
      designed specifically to facilitate mixed-methods analysis. We will then use constructive
      grounded theory analysis to develop coding categories based on the themes embedded in the
      datasets that fall within domains of interest. (12) In particular, we will be examining the
      qualitative data for themes describing: 1) what their experiences were like with the
      resiliency class; 2) what aspects of the resiliency class worked to improve their mood; 3)
      what aspects of the resiliency class did not improve their mood; 4) what they felt needed to
      be improved about the resiliency class and the manual; 5) how they suggest improving the
      resiliency class and manual.

      Phase II Analysis of Baseline and 3 month follow-up interview data The main analyses will be
      intent-to-treat comparing main effects of CBT intervention versus case management calls
      control. We hypothesizes that CBT class will have a greater impact on reducing depressive
      symptoms (PHQ-8) than control. We will also examine the intervention effects on other study
      measures (e.g. MCS-12, PCS12, substance use, use of health and mental health services). We
      will use an ANCOVA model that specifies the outcome measure observed at the 3 months as the
      dependent variable (e.g. PHQ-8), treatment group as the independent variable, controlled for
      the baseline measure for the same outcome as the covariate. For binary outcomes (e.g.
      substance use or prior use of antidepressant medication) we will fit a logistic regression
      model.

      General Analytic Strategies Univariate distributions will be examined to identify outliers
      and assess their influence on the analyses. Issues to be considered include errors in data
      input, scoring or other sources of invalidity in the measurements. The data will be carefully
      inspected to determine the need for scale transformations and to identify missing data,
      outliers, or other unusual features. To improve the precision of the estimated intervention
      effect, we will conduct a series of bivariate analyses to identify the potential covariates
      to be considered for a multiple regression model. Confounding will be assessed by comparing
      the unadjusted coefficient for treatment condition with the adjusted coefficient. Assumptions
      of normality will also be evaluated. For example, we will explore various transformations
      (e.g., log) for number of visits due to the often skewed distribution of event counts.
      Smearing estimates will be used, if necessary, for retransformation, applying separate
      factors for each intervention group to ensure consistent estimates (13) In general, we leave
      open the possibility of transforming variables with non-normal distributions (14) In certain
      cases, the outcome of interest will have a skewed distribution, either because there will be
      many zeros (e.g. days of work missed due to illness) and/or because the distribution of
      observed values has a very long tail (e.g. services utilization). In such cases, we will draw
      upon statistical models developed for these type of data, in particular a two-part model to
      separately handle zero values and a skewed distribution among non-zeros (13). Tobit-type
      sample selection models (15); split-sample techniques to distinguish between different
      functional forms and to avoid overfitting (13); and dynamic models, such as episodes of care
      analytic models, duration analysis, and count models (16).

      To improve the precision of the estimated intervention effect, we will conduct a series of
      bivariate analyses to identify the potential covariates to be considered for a multiple
      regression model. Confounding will be assessed by comparing the unadjusted coefficient for
      treatment condition with the adjusted coefficient. We will consider multiple imputation to
      account for unit level non-response (17) We will inspect patterns of missing data. If
      non-response appears to be non-ignorable we will employ statistical techniques such as
      pattern mixture models and related methods ; and otherwise imputation strategies will assume
      that non-response is ignorable (i.e. missing at random). (13, 17-19)

      Description of measures B-RICH PARTICIPANT STUDY SCREENER Age PHQ-2 Whether they know
      provider or staff member they see at agency

      BASELINE INTERVIEW Health status Gender Marital status Children under age 18 living at home
      Health Insurance coverage Education Employment Born in the U.S. Ethnicity Housing PHQ-8
      Function: SF-12 Fordyce Emotions Questionnaire Brief Resiliency Scale Use of Services
      (health, mental health, substance use, social services, religious, parks and recreation)
      Current Medication Use Satisfaction with Services Beliefs about people with depression
      Beliefs about treating depression Chronic Conditions (medical, smoking, weight, height,
      physical activity) Current and Past Use of Alcohol / Drugs Life Difficulties in Past 6 months
      Coping Strategies Social Supports Employment, work missed for those employed Income Income,
      income from governmental sources Food security

      3 MONTH FOLLOW-UP INTERVIEW Demographics Date of birth Marital status Housing PHQ-8 Function:
      SF-12 Fordyce Emotions Questionnaire Brief Resiliency Scale Use of Services (health, mental
      health, substance use, social services, religious, parks and recreation) Current Use
      Medications Beliefs about people with depression Beliefs about treating depression Chronic
      Conditions (medical, smoking, weight, height, physical activity) Current and Past Use of
      Alcohol / Drugs Life Difficulties in Past 6 months Coping Strategies Social Supports
      Employment, work missed for those employed Income, income from governmental sources Food
      security

      Phase II RCT:

      All data collection was completed in 2014. Study participants were screened (n=310) and
      enrolled (n=168) from community-based organizations located in South Los Angeles including a
      Women, Infants, and Children (WIC) program; a senior center; a church; a faith-based,
      low-income senior housing facility; a health advocacy organization, a YMCA, and a federally
      qualified health center. 84 participants were randomized into the case management assessment
      and referral arm and 84 into the resiliency class intervention.

      Data analyses are currently under way and we are preparing a manuscript with the findings for
      publication in the next several months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Depressive symptom count as measured by the Patient Health Questionnaire 8
time frame: Change from Baseline in Depressive Symptoms at 3 months
description: The Patient Health Questionnaire (PHQ) 8 is a standard measure of depressive symptoms.
measure: mental health related quality of life (MCS-12) from the Short Form 12 item - Health Survey
time frame: Baseline, 3 months
description: Mental health related quality of life from the mental component of the Short Form 12-item Health Survey (SF-12). The SF-12 is a multipurpose short-form (SF) generic measure of health status. The 12 items in the SF-12 are a subset of those in the SF-36. SF-12 includes on or items from each of the eight health concepts. Therefore, the SF-12 measures eight concepts of health status: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well being). The first four health concepts indicate physical health status and the others indicate mental health status.
measure: Client Use of Services
time frame: Baseline, 3 month
description: The client use of services Scale is a 49 item measure that assesses access to and use of general health services in the community. This includes hospitalizations, ER visits, Mental Health Services, Substance Abuse Services, Social and Community-based Services, and other trusted locations.
measure: Current Medication Use
time frame: Baseline, 3 month
description: The current medication use is a measure with 3 items created to identify any prescribed medications being consumed for mental or emotional problems such as depression, anxiety, or nerves.
measure: Satisfaction with Community Services
time frame: Baseline, 3 month
description: The satisfaction with community services is a measure with 5 items (1-very dissatisfied to 5- very satisfied) used to assess the satisfaction of the availability of health and social services in community.
measure: Chronic Conditions
time frame: Baseline, 3 month
description: The chronic condition is a standard measure of health problems some people may have (medical, smoking, weight, height, physical activity). There are 23 items in this measure.
measure: Current and Past Use of Alcohol / Drugs
time frame: Baseline, 3 month
description: The current and past use of alcohol or drugs is a measure with 13 items created to assess the use of illicit drugs or alcohol abuse.
measure: Life Difficulties in Past 3 months
time frame: Baseline, 3 month
description: The life difficulties during the past six months is a 15 item measure created to identify life stress events.
measure: Coping Strategies
time frame: Baseline, 3 month
description: The coping strategies questionnaire is a 4 item measure used to determine any use of avoidant and/or active coping strategies to stressful situations or problems.
measure: Social Supports
time frame: Baseline, 3 month
description: The social support survey is a 10 item measure created to help assess various dimensions of social support (emotional, affectionate, and positive social interaction).
measure: Employment, work missed for those employed
time frame: Baseline, 3 month
description: The employment questionnaire has 18 items that assesses the employment situation of participants. There are 4 additional items reporting any days missed of work.
measure: Income
time frame: Baseline, 3 month
description: The income survey is a 16 item measure created to evaluate the level of income within each household and whether families received income from any government programs.
measure: Food Security
time frame: Baseline, 3 month
description: The food security is a 2 item measure created to determine household food security .
measure: Fordyce Emotions Questionnaire
time frame: baseline, 3 months
description: This questionnaire assesses current happiness with four questions. The first question assesses current happiness on a scale of 0 (extremely unhappy) to 10 (extremely happy). Questions 2 through 4 asks the percent of time the respondent feels happy; percent of time unhappy; and percent of time neutral.
arm group label: Resiliency Class
arm group type: Experimental
description: Resiliency Classes (study group) Study participant randomized to the Resiliency classes will be offered and assigned a time and date to attend the classes. Each class will have up to 10 participants. Classes will be 90-120 minutes in duration and will be held weekly for six weeks. At the classes, participants will be offered a copy of the Resiliency Class Manual. And at each class, light snacks and refreshments will be offered.
The Resiliency Class manual covers the following topics:
Session 1 - "What Affects Your Mood and Resilience;" Session 2 - "Pleasant Activities Can Help Improve Your Mood and Make You Resilient;" Session 3 - "What Gets In The Way of Pleasant Activities: Harmful Thoughts and How to Change Them;" Session 4 - "How to Increase Your Resilience Through Support from Others;" Session 5 - "My Personal Resiliency Plan: Goal Setting;" Session 6 - "Celebrate Your Resiliency: Graduation"
arm group label: Case Management
arm group type: Active Comparator
description: Case management phone calls (control group) Study participants randomized to the case management phone calls will be told that they will receive two calls over two months by study staff to offer them referrals based on their perceived need for services to local health care, mental health, substance use, social services, child welfare, housing, and food. In addition, study participants in this arm of the study will be told that if the study determines that the resiliency classes are better at improving mood than the case management calls, they will receive a call to invite them to participate in resiliency classes for free at the B-RICH partner agencies.
intervention type: Behavioral
intervention name: Resiliency Class
description: See Arm Description
arm group label: Resiliency Class
intervention type: Other
intervention name: Case Management
description: See Case Management description
arm group label: Case Management
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bowen Chung, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Bowen Chung, MD, MSHS
investigator title: Associate Professor-in-Residence
mesh term: Depression
sharing ipd: No
ipd description: There are no current plans to share a de-identified, individual participant data as a publicly available dataset due to the original funding not including resources to support this activity; however on a case-by-case basis, the PI would consider additional analyses of the data by other investigators.