<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/NCT02986945</url>
  </required_header>
  <id_info>
    <org_study_id>RHINO 2013-0834</org_study_id>
    <nct_id>NCT02986945</nct_id>
  </id_info>
  <brief_title>Community-Partnered Participatory Development of Mobile Interventions</brief_title>
  <official_title>Community-Partnered Participatory Development of Mobile Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RAND</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RAND</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to test an experimental method, a text-messaging app called&#xD;
      B-RESILIENT, for improving participants' mood. B-RESILIENT is a text messaging app adaptation&#xD;
      of a Resiliency Course, developed by community members known as Building Resiliency and&#xD;
      Community Hope.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In phase 1, the investigators held a series of in-person and virtual workshops with the&#xD;
      Partnered Research Center for Quality Care (PRC) community partners to co-develop mobile&#xD;
      interventions to address community priorities. The goal of the workshops was to develop novel&#xD;
      mobile interventions based on stakeholder input. The specific intervention to be developed&#xD;
      was determined based on stakeholder input regarding community priorities during the&#xD;
      workshops. Workshops were audio and/or video recorded to document the process. One of the&#xD;
      tools used in this process was the Chorus Participatory Mobile Framework created at the&#xD;
      Center for Health Services and Society at UCLA. Chorus is a web application that allows users&#xD;
      to easily create mobile (text messaging and interactive voice) applications in real-time&#xD;
      without requiring any server programming. The investigators used this framework during the&#xD;
      workshops to develop and test the application in real-time. Participants were also given&#xD;
      phone numbers to call or text in to the intervention that they co-developed for the purpose&#xD;
      of testing, providing feedback, and guiding future development.&#xD;
&#xD;
      In phase 2, the investigators will conduct a pilot randomized control trial of the&#xD;
      B-RESILIENT tool developed during the workgroup phase 1. Investigators will enroll 30 adults&#xD;
      in South Los Angeles to participate in a randomized, wait-list trial. The study group will&#xD;
      receive the intervention for 4 weeks, followed by the wait-list group for another 4 weeks.&#xD;
      Investigators will conduct baseline and follow-up surveys, as well as in-person or telephone&#xD;
      workgroups, to assess the tool's usability and feasibility for supporting management of mood&#xD;
      and depressive symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">March 28, 2017</completion_date>
  <primary_completion_date type="Actual">March 28, 2017</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>None (Open Label)</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 1 month</time_frame>
    <description>The Patient Health Questionnaire (PHQ) 8 is a standard measure of depressive symptoms.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Fordyce Emotions Questionnaire</measure>
    <time_frame>Change from baseline at 1 month</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>
  <other_outcome>
    <measure>Brief Resilience Scale</measure>
    <time_frame>Change from baseline at 1 month</time_frame>
    <description>A 6 item measure of the ability to bounce back or recover from stress.</description>
  </other_outcome>
  <other_outcome>
    <measure>Coping Strategies</measure>
    <time_frame>Change from baseline at 1 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>Change from baseline at 1 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>Change from baseline at 1 month</time_frame>
    <description>The employment questionnaire has 1 item 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>Change from baseline at 1 month</time_frame>
    <description>The income survey is a 1 item measure created to evaluate the level of income within each household.</description>
  </other_outcome>
  <other_outcome>
    <measure>Client Use of Services</measure>
    <time_frame>Change from baseline at 1 month</time_frame>
    <description>The client use of services Scale is an 6 item measure that assesses access to and use of general health services in the community. This includes hospitalizations, ER visits, Mental Health Services, Social and Community-based Services, and other trusted locations.</description>
  </other_outcome>
  <other_outcome>
    <measure>Current Medication Use</measure>
    <time_frame>Change from baseline at 1 month</time_frame>
    <description>The current medication use is a measure with 2 items created to identify any prescribed medications being consumed for mental or emotional problems such as depression, anxiety, or nerves.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>Immediate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resiliency App: Study participants randomized to the Immediate group will receive the text-messaging app, B-RESILIENT-an adaptation of a Resiliency Course for improving mood in individuals with depressive symptoms--for 4 weeks.&#xD;
Wk 1: BOOST - manage unhealthy thoughts. Wk 2: BREAK - doing pleasant activities. Wk 3: BUDDY - effective communication for social support. Wk 4: Review of first 3 weeks. Each day, users will receive a daily affirmation text message, a series of approximately 5-10 text messages on the topic of the day, and a daily goal corresponding to the day's content (e.g. do a pleasant activity). At the end of the day, users will receive text messages asking them to report whether they completed the daily goal, followed by a daily mood measure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Resiliency App: The Delayed arm will receive the intervention after the Immediate Arm completes its use of the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resiliency App</intervention_name>
    <arm_group_label>Delayed</arm_group_label>
    <arm_group_label>Immediate</arm_group_label>
    <other_name>B-RESILIENT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 or older&#xD;
&#xD;
          2. Speak English&#xD;
&#xD;
          3. Endorse one item on the PHQ-2&#xD;
&#xD;
          4. Are able to be contacted by phone or email, and have a cell phone that receives text&#xD;
             messages&#xD;
&#xD;
          5. Have internet access&#xD;
&#xD;
        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;
          4. No cell phone and internet access&#xD;
&#xD;
          5. Currently homeless&#xD;
&#xD;
          6. Has a prior diagnosis of schizophrenia, psychosis, bipolar disorder&#xD;
&#xD;
          7. Current alcohol and substance abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer O'Hora, PhD</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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 1, 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>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depressive symptoms</keyword>
  <keyword>resiliency</keyword>
  <keyword>Health Promotion</keyword>
  <keyword>minority health</keyword>
  <keyword>text-messaging app</keyword>
  <keyword>participatory technology development</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>
  </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/NCT02986945
org study id: RHINO 2013-0834
nct id: NCT02986945
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to test an experimental method, a text-messaging app called
      B-RESILIENT, for improving participants' mood. B-RESILIENT is a text messaging app adaptation
      of a Resiliency Course, developed by community members known as Building Resiliency and
      Community Hope.
In phase 1, the investigators held a series of in-person and virtual workshops with the
      Partnered Research Center for Quality Care (PRC) community partners to co-develop mobile
      interventions to address community priorities. The goal of the workshops was to develop novel
      mobile interventions based on stakeholder input. The specific intervention to be developed
      was determined based on stakeholder input regarding community priorities during the
      workshops. Workshops were audio and/or video recorded to document the process. One of the
      tools used in this process was the Chorus Participatory Mobile Framework created at the
      Center for Health Services and Society at UCLA. Chorus is a web application that allows users
      to easily create mobile (text messaging and interactive voice) applications in real-time
      without requiring any server programming. The investigators used this framework during the
      workshops to develop and test the application in real-time. Participants were also given
      phone numbers to call or text in to the intervention that they co-developed for the purpose
      of testing, providing feedback, and guiding future development.

      In phase 2, the investigators will conduct a pilot randomized control trial of the
      B-RESILIENT tool developed during the workgroup phase 1. Investigators will enroll 30 adults
      in South Los Angeles to participate in a randomized, wait-list trial. The study group will
      receive the intervention for 4 weeks, followed by the wait-list group for another 4 weeks.
      Investigators will conduct baseline and follow-up surveys, as well as in-person or telephone
      workgroups, to assess the tool's usability and feasibility for supporting management of mood
      and depressive symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Depressive symptom count as measured by the Patient Health Questionnaire 8
time frame: Change from baseline at 1 month
description: The Patient Health Questionnaire (PHQ) 8 is a standard measure of depressive symptoms.
measure: Fordyce Emotions Questionnaire
time frame: Change from baseline at 1 month
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.
measure: Brief Resilience Scale
time frame: Change from baseline at 1 month
description: A 6 item measure of the ability to bounce back or recover from stress.
measure: Coping Strategies
time frame: Change from baseline at 1 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: Change from baseline at 1 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: Change from baseline at 1 month
description: The employment questionnaire has 1 item that assesses the employment situation of participants. There are 4 additional items reporting any days missed of work.
measure: Income
time frame: Change from baseline at 1 month
description: The income survey is a 1 item measure created to evaluate the level of income within each household.
measure: Client Use of Services
time frame: Change from baseline at 1 month
description: The client use of services Scale is an 6 item measure that assesses access to and use of general health services in the community. This includes hospitalizations, ER visits, Mental Health Services, Social and Community-based Services, and other trusted locations.
measure: Current Medication Use
time frame: Change from baseline at 1 month
description: The current medication use is a measure with 2 items created to identify any prescribed medications being consumed for mental or emotional problems such as depression, anxiety, or nerves.
arm group label: Immediate
arm group type: Experimental
description: Resiliency App: Study participants randomized to the Immediate group will receive the text-messaging app, B-RESILIENT-an adaptation of a Resiliency Course for improving mood in individuals with depressive symptoms--for 4 weeks.
Wk 1: BOOST - manage unhealthy thoughts. Wk 2: BREAK - doing pleasant activities. Wk 3: BUDDY - effective communication for social support. Wk 4: Review of first 3 weeks. Each day, users will receive a daily affirmation text message, a series of approximately 5-10 text messages on the topic of the day, and a daily goal corresponding to the day's content (e.g. do a pleasant activity). At the end of the day, users will receive text messages asking them to report whether they completed the daily goal, followed by a daily mood measure.
arm group label: Delayed
arm group type: Other
description: Resiliency App: The Delayed arm will receive the intervention after the Immediate Arm completes its use of the intervention.
intervention type: Behavioral
intervention name: Resiliency App
arm group label: Delayed
arm group label: Immediate
other name: B-RESILIENT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer O'Hora, PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No