Community-Partnered Participatory Development of Mobile Interventions

NCT ID: NCT02986945

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2017-03-28

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.

Conditions

Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Resiliency App

Intervention Type: BEHAVIORAL

Delayed

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

Group Type: OTHER

Resiliency App

Intervention Type: BEHAVIORAL

Interventions

Resiliency App

Intervention Type: BEHAVIORAL

Other Intervention Names

B-RESILIENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

RAND

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer O'Hora, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Healthy African American Families

Los Angeles, California, United States

Countries

United States

Other Identifiers

RHINO 2013-0834

Identifier Type: -

Identifier Source: org_study_id