<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/NCT02986126</url>
  </required_header>
  <id_info>
    <org_study_id>PPRND-1507-32173</org_study_id>
    <nct_id>NCT02986126</nct_id>
  </id_info>
  <brief_title>Resilience Against Depression Disparities (Also Known as Resilience Education to Reduce Depression Disparities)</brief_title>
  <acronym>RADD</acronym>
  <official_title>Resilience Against Depression Disparities (Also Known as Resilience Education to Reduce Depression Disparities)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bowen Chung, MD, MSHS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Louisiana State University Health Sciences Center in New Orleans</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tulane University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Healthy African American Families II</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Arming Minorities Against Addiction &amp; Disease</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Louisiana Community Health Outreach Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depressive symptoms and disorders are among the most common adult health conditions with a&#xD;
      lifetime prevalence of 15-20% and are a leading cause of disability /morbidity worldwide.&#xD;
      Although evidence-based approaches such as cognitive behavioral therapy (CBT), antidepressant&#xD;
      medications, and depression collaborative care and quality improvement (QI) programs&#xD;
      integrating depression care into primary health care can improve depression outcomes and&#xD;
      disparities, racial / ethnic disparities continue to persist. Concurrently, according to a&#xD;
      2011 Institute of Medicine (IOM) report, little information exists on how to address the high&#xD;
      rates of depression among sexual and gender minorities.&#xD;
&#xD;
      Our study randomizes depressed, LGBTQ (lesbian, gay, bisexual, transgendered, queer), racial&#xD;
      / ethnic minority adults to an evidence-based agency-level, depression quality improvement&#xD;
      (QI) training [Resources for Services (RS)] and technical support alone or to a resiliency&#xD;
      class (RC+), a 7-session resiliency, cognitive behavioral therapy class to enhance mood +&#xD;
      automated mobile text reminders about basic reminders and care follow-up impact on improving&#xD;
      adult patients' depressive symptoms. Depression QI (RS) training will be offered to three&#xD;
      clusters of four to five LGBTQ-focused programs: two clusters in LA (Hollywood and South LA)&#xD;
      and one cluster in NO. Clusters are comprised of one primary care, one mental health, and two&#xD;
      to three community agencies (e.g., faith-based, social services/support, advocacy). All&#xD;
      programs will receive depression QI training. Enrolled adult depressed patients (n=320) will&#xD;
      be randomized individually to RC+ or RS (depression QI) alone to assess effects on primary&#xD;
      outcomes: depressive symptoms [8-item patient health questionnaire (PHQ-8) score and&#xD;
      secondary outcomes: mental health quality of life [12-item mental composite score (MCS-12) ≤&#xD;
      40], Resilience (Brief Resilience Scale), mental wellness, and physical health quality of&#xD;
      life [12-item physical composite (PCS-12)score] at 6- and 12-month follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depressive symptoms and disorders are among the most common adult health conditions and are a&#xD;
      leading cause of disability /morbidity worldwide. Although evidence-based approaches such as&#xD;
      cognitive behavioral therapy (CBT), antidepressant medications, and depression collaborative&#xD;
      care and quality improvement (QI) programs integrating depression care into primary health&#xD;
      care can improve depression outcomes and disparities, racial / ethnic disparities continue to&#xD;
      persist. Concurrently, according to a 2011 Institute of Medicine (IOM) report notes little&#xD;
      information exists on how to address the high rates of depression among sexual and gender&#xD;
      minorities, largely composed of lesbian, gay, and bisexual (LGBTQ) individuals. Limited&#xD;
      comparative effectiveness data exists to know what treatments and services options improve&#xD;
      health disparities due to patient characteristics such as race / ethnicity, and sexual&#xD;
      orientation.&#xD;
&#xD;
      &quot;Resilience Against Depression Disparities (RADD)&quot; randomizes enrolled depressed, LGBTQ,&#xD;
      racial / ethnic minority adults (n=320) to an agency-level, evidence-based depression quality&#xD;
      improvement (QI) intervention [Resources for Services (RS)] training and technical support&#xD;
      and then randomizes individuals to Resources for Services alone or to Resiliency Class+, a&#xD;
      7-session resiliency, depression cognitive behavioral therapy class + automated mobile text&#xD;
      reminders about basic reminders and care follow-up impact on improving adult patients'&#xD;
      depressive symptoms over 6- and 12-months. RS training will be offered to three clusters of&#xD;
      four to five LGBTQ-focused programs: two clusters in LA (Hollywood and South LA) and one&#xD;
      cluster in NO. Clusters are comprised of one primary care, one mental health, and two to&#xD;
      three community agencies (e.g., faith-based, social services/support, advocacy). All programs&#xD;
      will receive RS (depression QI training). All enrolled adult depressed patients will be&#xD;
      within programs participating in RS (depression QI) trainings. Half of enrolled participants&#xD;
      will be randomized to the Resilience Class +.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 4, 2017</start_date>
  <completion_date type="Anticipated">November 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2019</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 at 6- and 12-month follow-up</time_frame>
    <description>The 8-item Patient Health Questionnaire (PHQ-8) is a standard measure of depressive symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Poor Mental Health-Related Quality of Life</measure>
    <time_frame>6- and 12-month follow-up</time_frame>
    <description>12-item mental composite score (MCS-12) ≤ 40</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilience</measure>
    <time_frame>6- and 12-month follow-up</time_frame>
    <description>Brief Resilience Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical health-related quality of life</measure>
    <time_frame>6- and 12-month follow-up</time_frame>
    <description>12-item physical composite score (PCS-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Wellness</measure>
    <time_frame>6- and 12-month follow-up</time_frame>
    <description>3 items in last 4 weeks: some feeling of being calm or peaceful, having energy or being happy (from 36-item Short Form Health Survey)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">265</enrollment>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>Resources for Services</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Resources for Services (RS) is an evidence-based depression QI toolkit developed for primary care, but adapted for health- and community-based programs. Protocols support training licensed providers in clinical assessment, medication management, and CBT; all staff in team management; and non-clinical staff in addressing patient safety, screening, behavioral management skills (behavioral activation, problem solving) to enable education, coordination, and referral. RS is offered as an initial 1-day / 8-hour training with follow-up through 12 webinars, 3 each on team management, medication management, psychotherapy, and case management. Programs will be invited to have a staff lead per training component, with no limit on number of staff at trainings. Training experts include a psychiatrist, psychologist/CBT trainer, case manager, support staff, and patient / community advocate liaison. All enrolled study participants will be nested within programs participating in RS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resiliency Class +</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Resiliency Classes (RC) are a manualized, 7-session, CBT, psychoeducation class, lead by community health workers, that teaches skills to enhance mood. The RC manual covers: 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; Each RC will be 90-120 minutes in duration; once a week in community settings with up to 10 participants. RC will be supplemented with automated mobile text reminders about basic concepts and follow-up for care. Half of enrolled participants will be randomized to the Resiliency Class +. As of July 12, 2018, we will be offering bus tokens and $5 for completion of a satisfaction survey.</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>Resource for Services (RS)</intervention_name>
    <description>See Resource for Services (RS) Description</description>
    <arm_group_label>Resiliency Class +</arm_group_label>
    <arm_group_label>Resources for Services</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 or older&#xD;
&#xD;
          2. moderately to severely depressed (PHQ-8≥10)&#xD;
&#xD;
          3. Able to be contacted by phone (voice or text message), e-mail, or Facebook.&#xD;
&#xD;
          4. English or Spanish speaker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Under age 18 years&#xD;
&#xD;
          2. Not moderately to severely depressed (PHQ-8≤10)&#xD;
&#xD;
          3. 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, MSHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>R.O.A.D.S. Clinic</name>
      <address>
        <city>Compton</city>
        <state>California</state>
        <zip>90221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The ADAM Project - YMSM Program</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The LGBTQ Center - Long Beach</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMAAD</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AIDS Health Foundation Healthcare Center - Downtown Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AIDS Health Foundation Healthcare Center - Hollywood</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AIDS Health Foundation Public Health Division</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metropolitan Community Church</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OASIS Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90059</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Transmasculine Alliance</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans Musicians Clinic</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Anna's Church</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crescent Care - The Community Awareness Network (CAN Office)</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crescent City Sanctuary</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metropolitan Community Church of New Orleans</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NOAGE</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brotherhood</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crescent Care - The Movement</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crescent Care</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odyssey Home</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sisters of Perpetual Indulgence - The Big Easy Sisters</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women with a Vision</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.pcori.org/research-results/2016/resiliency-education-reduce-depression-disparities</url>
    <description>Patient-Centered Outcomes Research Institute Project Summary</description>
  </link>
  <results_reference>
    <citation>Moussavi S, Chatterji S, Verdes E, Tandon A, Patel V, Ustun B. Depression, chronic diseases, and decrements in health: results from the World Health Surveys. Lancet. 2007 Sep 8;370(9590):851-8. doi: 10.1016/S0140-6736(07)61415-9.</citation>
    <PMID>17826170</PMID>
  </results_reference>
  <results_reference>
    <citation>Miranda J, Chung JY, Green BL, Krupnick J, Siddique J, Revicki DA, Belin T. Treating depression in predominantly low-income young minority women: a randomized controlled trial. JAMA. 2003 Jul 2;290(1):57-65. doi: 10.1001/jama.290.1.57.</citation>
    <PMID>12837712</PMID>
  </results_reference>
  <results_reference>
    <citation>Wells KB, Sherbourne C, Schoenbaum M, Duan N, Meredith L, Unutzer J, Miranda J, Carney MF, Rubenstein LV. Impact of disseminating quality improvement programs for depression in managed primary care: a randomized controlled trial. JAMA. 2000 Jan 12;283(2):212-20. doi: 10.1001/jama.283.2.212. Erratum In: JAMA 2000 Jun 28;283(24):3204.</citation>
    <PMID>10634337</PMID>
  </results_reference>
  <results_reference>
    <citation>Wells KB, Tang L, Miranda J, Benjamin B, Duan N, Sherbourne CD. The effects of quality improvement for depression in primary care at nine years: results from a randomized, controlled group-level trial. Health Serv Res. 2008 Dec;43(6):1952-74. doi: 10.1111/j.1475-6773.2008.00871.x. Epub 2008 Jun 3.</citation>
    <PMID>18522664</PMID>
  </results_reference>
  <results_reference>
    <citation>Gilbody S, Bower P, Fletcher J, Richards D, Sutton AJ. Collaborative care for depression: a cumulative meta-analysis and review of longer-term outcomes. Arch Intern Med. 2006 Nov 27;166(21):2314-21. doi: 10.1001/archinte.166.21.2314.</citation>
    <PMID>17130383</PMID>
  </results_reference>
  <results_reference>
    <citation>Miranda J, Duan N, Sherbourne C, Schoenbaum M, Lagomasino I, Jackson-Triche M, Wells KB. Improving care for minorities: can quality improvement interventions improve care and outcomes for depressed minorities? Results of a randomized, controlled trial. Health Serv Res. 2003 Apr;38(2):613-30. doi: 10.1111/1475-6773.00136.</citation>
    <PMID>12785564</PMID>
  </results_reference>
  <results_reference>
    <citation>Institute of Medicine (US) Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK64806/</citation>
    <PMID>22013611</PMID>
  </results_reference>
  <results_reference>
    <citation>Springgate BF, Wennerstrom A, Meyers D, Allen CE 3rd, Vannoy SD, Bentham W, Wells KB. Building community resilience through mental health infrastructure and training in post-Katrina New Orleans. Ethn Dis. 2011 Summer;21(3 Suppl 1):S1-20-9.</citation>
    <PMID>22352077</PMID>
  </results_reference>
  <results_reference>
    <citation>Wells KB, Jones L, Chung B, Dixon EL, Tang L, Gilmore J, Sherbourne C, Ngo VK, Ong MK, Stockdale S, Ramos E, Belin TR, Miranda J. Community-partnered cluster-randomized comparative effectiveness trial of community engagement and planning or resources for services to address depression disparities. J Gen Intern Med. 2013 Oct;28(10):1268-78. doi: 10.1007/s11606-013-2484-3. Epub 2013 May 7. Erratum In: J Gen Intern Med. 2013 Nov;28(11):1534.</citation>
    <PMID>23649787</PMID>
  </results_reference>
  <results_reference>
    <citation>Chung B, Ong M, Ettner SL, Jones F, Gilmore J, McCreary M, Sherbourne C, Ngo V, Koegel P, Tang L, Dixon E, Miranda J, Belin TR, Wells KB. 12-month outcomes of community engagement versus technical assistance to implement depression collaborative care: a partnered, cluster, randomized, comparative effectiveness trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S23-34. doi: 10.7326/M13-3011.</citation>
    <PMID>25402400</PMID>
  </results_reference>
  <results_reference>
    <citation>Chung B, Ngo VK, Ong MK, Pulido E, Jones F, Gilmore J, Stoker-Mtume N, Johnson M, Tang L, Wells KB, Sherbourne C, Miranda J. Participation in Training for Depression Care Quality Improvement: A Randomized Trial of Community Engagement or Technical Support. Psychiatr Serv. 2015 Aug 1;66(8):831-9. doi: 10.1176/appi.ps.201400099. Epub 2015 May 1.</citation>
    <PMID>25930037</PMID>
  </results_reference>
  <results_reference>
    <citation>Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.</citation>
    <PMID>21190455</PMID>
  </results_reference>
  <results_reference>
    <citation>U.S. Department of Health and Human Services. Advancing LGBT Health &amp; Well-Being: 2014 Report. 2014; http://www.hhs.gov/programs/topic-sites/lgbt/index.html.</citation>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>August 13, 2018</last_update_submitted>
  <last_update_submitted_qc>August 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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>Depression</keyword>
  <keyword>Resilience</keyword>
  <keyword>Minority health</keyword>
  <keyword>Community-based participatory research</keyword>
  <keyword>Lesbian, gay, bisexual, transgender, and intersex (LGBTI) health</keyword>
  <keyword>Racial / ethnic health disparities</keyword>
  <keyword>Patient-centered outcomes research</keyword>
  <keyword>Comparative-effectiveness research</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We will work with the Patient-Centered Outcomes Research Institute (PCORI) staff as the findings emerge to determine the potential value of some or all of the dataset being made publicly available, which would require additional funding from PCORI to complete. In general PCORI works with investigators to make a complete, cleaned, de-identified final data set with detailed descriptions contained within the study protocol available to PCORI for use as a publicly available dataset after study completion.</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/NCT02986126
org study id: PPRND-1507-32173
nct id: NCT02986126
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Depressive symptoms and disorders are among the most common adult health conditions with a
      lifetime prevalence of 15-20% and are a leading cause of disability /morbidity worldwide.
      Although evidence-based approaches such as cognitive behavioral therapy (CBT), antidepressant
      medications, and depression collaborative care and quality improvement (QI) programs
      integrating depression care into primary health care can improve depression outcomes and
      disparities, racial / ethnic disparities continue to persist. Concurrently, according to a
      2011 Institute of Medicine (IOM) report, little information exists on how to address the high
      rates of depression among sexual and gender minorities.

      Our study randomizes depressed, LGBTQ (lesbian, gay, bisexual, transgendered, queer), racial
      / ethnic minority adults to an evidence-based agency-level, depression quality improvement
      (QI) training [Resources for Services (RS)] and technical support alone or to a resiliency
      class (RC+), a 7-session resiliency, cognitive behavioral therapy class to enhance mood +
      automated mobile text reminders about basic reminders and care follow-up impact on improving
      adult patients' depressive symptoms. Depression QI (RS) training will be offered to three
      clusters of four to five LGBTQ-focused programs: two clusters in LA (Hollywood and South LA)
      and one cluster in NO. Clusters are comprised of one primary care, one mental health, and two
      to three community agencies (e.g., faith-based, social services/support, advocacy). All
      programs will receive depression QI training. Enrolled adult depressed patients (n=320) will
      be randomized individually to RC+ or RS (depression QI) alone to assess effects on primary
      outcomes: depressive symptoms [8-item patient health questionnaire (PHQ-8) score and
      secondary outcomes: mental health quality of life [12-item mental composite score (MCS-12) ≤
      40], Resilience (Brief Resilience Scale), mental wellness, and physical health quality of
      life [12-item physical composite (PCS-12)score] at 6- and 12-month follow-up.
Depressive symptoms and disorders are among the most common adult health conditions and are a
      leading cause of disability /morbidity worldwide. Although evidence-based approaches such as
      cognitive behavioral therapy (CBT), antidepressant medications, and depression collaborative
      care and quality improvement (QI) programs integrating depression care into primary health
      care can improve depression outcomes and disparities, racial / ethnic disparities continue to
      persist. Concurrently, according to a 2011 Institute of Medicine (IOM) report notes little
      information exists on how to address the high rates of depression among sexual and gender
      minorities, largely composed of lesbian, gay, and bisexual (LGBTQ) individuals. Limited
      comparative effectiveness data exists to know what treatments and services options improve
      health disparities due to patient characteristics such as race / ethnicity, and sexual
      orientation.

      "Resilience Against Depression Disparities (RADD)" randomizes enrolled depressed, LGBTQ,
      racial / ethnic minority adults (n=320) to an agency-level, evidence-based depression quality
      improvement (QI) intervention [Resources for Services (RS)] training and technical support
      and then randomizes individuals to Resources for Services alone or to Resiliency Class+, a
      7-session resiliency, depression cognitive behavioral therapy class + automated mobile text
      reminders about basic reminders and care follow-up impact on improving adult patients'
      depressive symptoms over 6- and 12-months. RS training will be offered to three clusters of
      four to five LGBTQ-focused programs: two clusters in LA (Hollywood and South LA) and one
      cluster in NO. Clusters are comprised of one primary care, one mental health, and two to
      three community agencies (e.g., faith-based, social services/support, advocacy). All programs
      will receive RS (depression QI training). All enrolled adult depressed patients will be
      within programs participating in RS (depression QI) trainings. Half of enrolled participants
      will be randomized to the Resilience Class +.
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 at 6- and 12-month follow-up
description: The 8-item Patient Health Questionnaire (PHQ-8) is a standard measure of depressive symptoms.
measure: Poor Mental Health-Related Quality of Life
time frame: 6- and 12-month follow-up
description: 12-item mental composite score (MCS-12) ≤ 40
measure: Resilience
time frame: 6- and 12-month follow-up
description: Brief Resilience Scale
measure: Physical health-related quality of life
time frame: 6- and 12-month follow-up
description: 12-item physical composite score (PCS-12)
measure: Mental Wellness
time frame: 6- and 12-month follow-up
description: 3 items in last 4 weeks: some feeling of being calm or peaceful, having energy or being happy (from 36-item Short Form Health Survey)
arm group label: Resources for Services
arm group type: Active Comparator
description: Resources for Services (RS) is an evidence-based depression QI toolkit developed for primary care, but adapted for health- and community-based programs. Protocols support training licensed providers in clinical assessment, medication management, and CBT; all staff in team management; and non-clinical staff in addressing patient safety, screening, behavioral management skills (behavioral activation, problem solving) to enable education, coordination, and referral. RS is offered as an initial 1-day / 8-hour training with follow-up through 12 webinars, 3 each on team management, medication management, psychotherapy, and case management. Programs will be invited to have a staff lead per training component, with no limit on number of staff at trainings. Training experts include a psychiatrist, psychologist/CBT trainer, case manager, support staff, and patient / community advocate liaison. All enrolled study participants will be nested within programs participating in RS.
arm group label: Resiliency Class +
arm group type: Active Comparator
description: Resiliency Classes (RC) are a manualized, 7-session, CBT, psychoeducation class, lead by community health workers, that teaches skills to enhance mood. The RC manual covers: 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" Each RC will be 90-120 minutes in duration; once a week in community settings with up to 10 participants. RC will be supplemented with automated mobile text reminders about basic concepts and follow-up for care. Half of enrolled participants will be randomized to the Resiliency Class +. As of July 12, 2018, we will be offering bus tokens and $5 for completion of a satisfaction survey.
intervention type: Behavioral
intervention name: Resiliency Class
description: See Arm Description
arm group label: Resiliency Class +
intervention type: Other
intervention name: Resource for Services (RS)
description: See Resource for Services (RS) Description
arm group label: Resiliency Class +
arm group label: Resources for Services
other name: Active Comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bowen Chung, MD, MSHS
role: Principal Investigator
affiliation: University of California, Los Angeles
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country: United States
url: http://www.pcori.org/research-results/2016/resiliency-education-reduce-depression-disparities
description: Patient-Centered Outcomes Research Institute Project Summary
citation: Moussavi S, Chatterji S, Verdes E, Tandon A, Patel V, Ustun B. Depression, chronic diseases, and decrements in health: results from the World Health Surveys. Lancet. 2007 Sep 8;370(9590):851-8. doi: 10.1016/S0140-6736(07)61415-9.
PMID: 17826170
citation: Miranda J, Chung JY, Green BL, Krupnick J, Siddique J, Revicki DA, Belin T. Treating depression in predominantly low-income young minority women: a randomized controlled trial. JAMA. 2003 Jul 2;290(1):57-65. doi: 10.1001/jama.290.1.57.
PMID: 12837712
citation: Wells KB, Sherbourne C, Schoenbaum M, Duan N, Meredith L, Unutzer J, Miranda J, Carney MF, Rubenstein LV. Impact of disseminating quality improvement programs for depression in managed primary care: a randomized controlled trial. JAMA. 2000 Jan 12;283(2):212-20. doi: 10.1001/jama.283.2.212. Erratum In: JAMA 2000 Jun 28;283(24):3204.
PMID: 10634337
citation: Wells KB, Tang L, Miranda J, Benjamin B, Duan N, Sherbourne CD. The effects of quality improvement for depression in primary care at nine years: results from a randomized, controlled group-level trial. Health Serv Res. 2008 Dec;43(6):1952-74. doi: 10.1111/j.1475-6773.2008.00871.x. Epub 2008 Jun 3.
PMID: 18522664
citation: Gilbody S, Bower P, Fletcher J, Richards D, Sutton AJ. Collaborative care for depression: a cumulative meta-analysis and review of longer-term outcomes. Arch Intern Med. 2006 Nov 27;166(21):2314-21. doi: 10.1001/archinte.166.21.2314.
PMID: 17130383
citation: Miranda J, Duan N, Sherbourne C, Schoenbaum M, Lagomasino I, Jackson-Triche M, Wells KB. Improving care for minorities: can quality improvement interventions improve care and outcomes for depressed minorities? Results of a randomized, controlled trial. Health Serv Res. 2003 Apr;38(2):613-30. doi: 10.1111/1475-6773.00136.
PMID: 12785564
citation: Institute of Medicine (US) Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK64806/
PMID: 22013611
citation: Springgate BF, Wennerstrom A, Meyers D, Allen CE 3rd, Vannoy SD, Bentham W, Wells KB. Building community resilience through mental health infrastructure and training in post-Katrina New Orleans. Ethn Dis. 2011 Summer;21(3 Suppl 1):S1-20-9.
PMID: 22352077
citation: Wells KB, Jones L, Chung B, Dixon EL, Tang L, Gilmore J, Sherbourne C, Ngo VK, Ong MK, Stockdale S, Ramos E, Belin TR, Miranda J. Community-partnered cluster-randomized comparative effectiveness trial of community engagement and planning or resources for services to address depression disparities. J Gen Intern Med. 2013 Oct;28(10):1268-78. doi: 10.1007/s11606-013-2484-3. Epub 2013 May 7. Erratum In: J Gen Intern Med. 2013 Nov;28(11):1534.
PMID: 23649787
citation: Chung B, Ong M, Ettner SL, Jones F, Gilmore J, McCreary M, Sherbourne C, Ngo V, Koegel P, Tang L, Dixon E, Miranda J, Belin TR, Wells KB. 12-month outcomes of community engagement versus technical assistance to implement depression collaborative care: a partnered, cluster, randomized, comparative effectiveness trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S23-34. doi: 10.7326/M13-3011.
PMID: 25402400
citation: Chung B, Ngo VK, Ong MK, Pulido E, Jones F, Gilmore J, Stoker-Mtume N, Johnson M, Tang L, Wells KB, Sherbourne C, Miranda J. Participation in Training for Depression Care Quality Improvement: A Randomized Trial of Community Engagement or Technical Support. Psychiatr Serv. 2015 Aug 1;66(8):831-9. doi: 10.1176/appi.ps.201400099. Epub 2015 May 1.
PMID: 25930037
citation: Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.
PMID: 21190455
citation: U.S. Department of Health and Human Services. Advancing LGBT Health & Well-Being: 2014 Report. 2014; http://www.hhs.gov/programs/topic-sites/lgbt/index.html.
responsible party type: Sponsor-Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Bowen Chung, MD, MSHS
investigator title: Associate Professor-in-Residence
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Undecided
ipd description: We will work with the Patient-Centered Outcomes Research Institute (PCORI) staff as the findings emerge to determine the potential value of some or all of the dataset being made publicly available, which would require additional funding from PCORI to complete. In general PCORI works with investigators to make a complete, cleaned, de-identified final data set with detailed descriptions contained within the study protocol available to PCORI for use as a publicly available dataset after study completion.