Community-Partnered Participatory Development of Mobile Interventions

Depressive Symptoms Clinical Trial

Official title:

Community-Partnered Participatory Development of Mobile Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986945
• Other study ID #: RHINO 2013-0834
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: March 28, 2017

Study information

• Verified date: April 2019
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 28, 2017
• Est. primary completion date: March 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Resiliency App

Locations

Country	Name	City	State
United States	Healthy African American Families	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
RAND	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Brief Resilience Scale	A 6 item measure of the ability to bounce back or recover from stress.	Change from baseline at 1 month
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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