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Community-Partnered Participatory Development of Mobile Interventions

Primary Purpose

Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resiliency App
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depressive Symptoms focused on measuring Depressive symptoms, resiliency, Health Promotion, minority health, text-messaging app, participatory technology development

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 or older
  2. Speak English
  3. Endorse one item on the PHQ-2
  4. Are able to be contacted by phone or email, and have a cell phone that receives text messages
  5. Have internet access

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
  4. No cell phone and internet access
  5. Currently homeless
  6. Has a prior diagnosis of schizophrenia, psychosis, bipolar disorder
  7. Current alcohol and substance abuse

Sites / Locations

  • Healthy African American Families

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate

Delayed

Arm 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.

Resiliency App: The Delayed arm will receive the intervention after the Immediate Arm completes its use of the intervention.

Outcomes

Primary Outcome Measures

Depressive symptom count as measured by the Patient Health Questionnaire 8
The Patient Health Questionnaire (PHQ) 8 is a standard measure of depressive symptoms.

Secondary Outcome Measures

Full Information

First Posted
December 1, 2016
Last Updated
April 15, 2019
Sponsor
RAND
Collaborators
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02986945
Brief Title
Community-Partnered Participatory Development of Mobile Interventions
Official Title
Community-Partnered Participatory Development of Mobile Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
March 28, 2017 (Actual)
Study Completion Date
March 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
Depressive symptoms, resiliency, Health Promotion, minority health, text-messaging app, participatory technology development

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate
Arm Type
Experimental
Arm 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 Title
Delayed
Arm Type
Other
Arm 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(s)
Resiliency App
Other Intervention Name(s)
B-RESILIENT
Primary Outcome Measure Information:
Title
Depressive symptom count as measured by the Patient Health Questionnaire 8
Description
The Patient Health Questionnaire (PHQ) 8 is a standard measure of depressive symptoms.
Time Frame
Change from baseline at 1 month
Other Pre-specified Outcome Measures:
Title
Fordyce Emotions Questionnaire
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.
Time Frame
Change from baseline at 1 month
Title
Brief Resilience Scale
Description
A 6 item measure of the ability to bounce back or recover from stress.
Time Frame
Change from baseline at 1 month
Title
Coping Strategies
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.
Time Frame
Change from baseline at 1 month
Title
Social Supports
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).
Time Frame
Change from baseline at 1 month
Title
Employment, work missed for those employed
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.
Time Frame
Change from baseline at 1 month
Title
Income
Description
The income survey is a 1 item measure created to evaluate the level of income within each household.
Time Frame
Change from baseline at 1 month
Title
Client Use of Services
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.
Time Frame
Change from baseline at 1 month
Title
Current Medication Use
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.
Time Frame
Change from baseline at 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older Speak English Endorse one item on the PHQ-2 Are able to be contacted by phone or email, and have a cell phone that receives text messages Have internet access Exclusion Criteria: Under age 18 years Endorse no items on PHQ-2 screener PHQ-8 score of 15 or greater on the baseline interview No cell phone and internet access Currently homeless Has a prior diagnosis of schizophrenia, psychosis, bipolar disorder Current alcohol and substance abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer O'Hora, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthy African American Families
City
Los Angeles
State/Province
California
ZIP/Postal Code
90008
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Community-Partnered Participatory Development of Mobile Interventions

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