Building Resiliency and Increasing Community Hope

NCT01698047 | Completed DMC

• 2 other identifiers: CCF-12-001142CMCH 12-97088
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to build a scientific evidence base for the training and delivery of a depressive symptoms education program, developed by local community members, called a Resiliency Class (RC). The RC has strong elements of Cognitive Behavioral Therapy and is designed to be delivered as a psycho-educational class by non-professionals to improve mood. Depressive symptoms are common, especially in low-income, minority communities. Depressive symptoms that don't meet DSM-IV criteria for Major Depression still carry a significant amount of disability. Interventions that address sub-threshold depressive symptoms have been noted to result in a decreased likelihood of depression and diminished use of mental health services. Few interventions using a health education / health promotion focus are designed to be delivered by non-professionals to address individuals with mild to moderate depressive symptoms in low income, minority communities. This project will take place in the Centinela Valley, which roughly corresponds to Service Planning Area (SPA) 6 or South Los Angeles (SLA). This single-blind, randomized trial will utilize a wait-list control design where half of the participants enrolled in the study will be randomized to the Resiliency Class (7 sessions) and half will go to a wait-list control condition where they will receive 2 case management calls and referrals to social services. We propose to screen 1500 clients to detect about 450 participants with depressive symptoms (endorsed one item on the PHQ-2). We plan to enroll 400 participants, 200 in the resiliency class and 200 in the wait-list control condition. Primary outcomes measures will include depressive symptoms, function, and measures of resiliency. We will assess these measures at baseline and at 3 months after completion of the Resiliency Class or wait-list condition. After the completion of the first round of classes, we will conduct a preliminary analysis of the impact of the resiliency classes versus the wait-list control case management calls on depressive symptoms. If the resiliency classes improve depressive symptoms more than the wait-list control, we will offer wait-list controls access to the resiliency classes and then disseminate the resiliency class through trainings. We hypothesize that the resiliency classes will lead to greater reductions in client depressive symptoms than the wait-list case management calls in the randomized trial of this project.

Conditions

Depressive Symptoms

Keywords

Depressive symptoms; sub-threshold depression; resiliency; Health Promotion; minority health

Outcome Measures

Primary Outcomes (1)

• 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 in Depressive Symptoms at 3 months

Secondary Outcomes (1)

• mental health related quality of life (MCS-12) from the Short Form 12 item - Health Survey

  Baseline, 3 months

Other Outcomes (12)

• Client Use of Services

  Baseline, 3 month

• Current Medication Use

  Baseline, 3 month

• Satisfaction with Community Services

  Baseline, 3 month

Study Arms (2)

Resiliency Class

EXPERIMENTAL

Resiliency Classes (study group) Study participant randomized to the Resiliency classes will be offered and assigned a time and date to attend the classes. Each class will have up to 10 participants. Classes will be 90-120 minutes in duration and will be held weekly for six weeks. At the classes, participants will be offered a copy of the Resiliency Class Manual. And at each class, light snacks and refreshments will be offered. The Resiliency Class manual covers the following topics: Session 1 - "What Affects Your Mood and Resilience;" Session 2 - "Pleasant Activities Can Help Improve Your Mood and Make You Resilient;" Session 3 - "What Gets In The Way of Pleasant Activities: Harmful Thoughts and How to Change Them;" Session 4 - "How to Increase Your Resilience Through Support from Others;" Session 5 - "My Personal Resiliency Plan: Goal Setting;" Session 6 - "Celebrate Your Resiliency: Graduation"

Behavioral: Resiliency Class

Case Management

ACTIVE COMPARATOR

Case management phone calls (control group) Study participants randomized to the case management phone calls will be told that they will receive two calls over two months by study staff to offer them referrals based on their perceived need for services to local health care, mental health, substance use, social services, child welfare, housing, and food. In addition, study participants in this arm of the study will be told that if the study determines that the resiliency classes are better at improving mood than the case management calls, they will receive a call to invite them to participate in resiliency classes for free at the B-RICH partner agencies.

Other: Case Management

Interventions

Resiliency Class BEHAVIORAL

See Arm Description

Resiliency Class

Case Management OTHER

See Case Management description

Case Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Endorse one item on the PHQ-2
• Able to be contacted by phone
• Able to participate in the six, weekly 90-120 minute sessions of the Resiliency Classes
• English or Spanish speaker

You may not qualify if:

• Under age 18 years
• Endorse no items on PHQ-2 screener
• PHQ-8 score of 15 or greater on the baseline interview
• \) Unable to be contacted by phone 4) Unable to attend the weekly resiliency classes
• Age 18 or older
• Endorse one of the first two items on the PHQ-8: "In the past two weeks, how often have you been bothered by 1) little interest or pleasure in doing things, 2) feeling down depressed or hopeless."
• Able to be contacted by phone (voice or text message), e-mail, or Facebook.
• Able to participate in the seven, weekly 90-120 minute sessions of the Resiliency Classes
• English or Spanish speaker
• Under age 18 years
• PHQ-8 score of 20 or greater on the baseline interview
• PHQ-8 score of 15 or greater and not currently in care and unwilling to get a referral for care
• Currently homeless
• Has a prior diagnosis of Bipolar Disorder
• Has a prior diagnosis of Schizophrenia

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator

Study Sites (3)

Healthy African American Families

Los Angeles, California, 90008, United States

Location

1st African Presbyterian Church

Los Angeles, California, 90047, United States

Location

Los Angeles Biomedical Research Institute

Torrance, California, 90509, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Case Management

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Bowen Chung, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-in-Residence

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 2, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)