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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02986945
Other study ID # RHINO 2013-0834
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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