Community-Partnered Participatory Development of Mobile Interventions

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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms
• Intervention / Treatment: Behavioral: Resiliency App

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90008
      • Healthy African American Families

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate; 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.	Behavioral: Resiliency App; Other Names: B-RESILIENT
Other: Delayed; Resiliency App: The Delayed arm will receive the intervention after the Immediate Arm completes its use of the intervention.	Behavioral: Resiliency App; Other Names: B-RESILIENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptom count as measured by the Patient Health Questionnaire 8	The Patient Health Questionnaire (PHQ) 8 is a standard measure of depressive symptoms.	Change from baseline at 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fordyce Emotions Questionnaire	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.	Change from baseline at 1 month
Brief Resilience Scale	A 6 item measure of the ability to bounce back or recover from stress.	Change from baseline at 1 month
Coping Strategies	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.	Change from baseline at 1 month
Social Supports	The social support survey is a 10 item measure created to help assess various dimensions of social support (emotional, affectionate, and positive social interaction).	Change from baseline at 1 month
Employment, work missed for those employed	The employment questionnaire has 1 item that assesses the employment situation of participants. There are 4 additional items reporting any days missed of work.	Change from baseline at 1 month
Income	The income survey is a 1 item measure created to evaluate the level of income within each household.	Change from baseline at 1 month
Client Use of Services	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.	Change from baseline at 1 month
Current Medication Use	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.	Change from baseline at 1 month

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: University of California, Los Angeles
• Investigators: Principal Investigator: Jennifer O'Hora, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): March 28, 2017
• Study Completion (Actual): March 28, 2017

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 5, 2016
• First Posted (Estimate): December 8, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Health Promotion; Depressive symptoms; minority health; resiliency; text-messaging app; participatory technology development
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: RHINO 2013-0834

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO