Building Resiliency and Increasing Community Hope (BRICH)

This study has been completed.
Sponsor:
Collaborator:
Los Angeles Biomedical Research Institute
Information provided by (Responsible Party):
Bowen Chung, MD, MSHS, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01698047
First received: September 26, 2012
Last updated: June 1, 2014
Last verified: June 2014
  Purpose

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 (6 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 6 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.


Condition Intervention
Depressive Symptoms
Behavioral: Resiliency Class
Other: Case Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Building Resiliency and Increasing Community Hope

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Depressive symptom count as measured by the Patient Health Questionnaire 8 [ Time Frame: Change from Baseline in Depressive Symptoms at 3 months ] [ Designated as safety issue: No ]
    The Patient Health Questionnaire (PHQ) 8 is a standard measure of depressive symptoms.


Secondary Outcome Measures:
  • mental health related quality of life (MCS-12) from the Short Form 12 item - Health Survey [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
    Mental health related quality of life from the mental component of the Short Form 12-item Health Survey (SF-12). The SF-12 is a multipurpose short-form (SF) generic measure of health status. The 12 items in the SF-12 are a subset of those in the SF-36. SF-12 includes on or items from each of the eight health concepts. Therefore, the SF-12 measures eight concepts of health status: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well being). The first four health concepts indicate physical health status and the others indicate mental health status.


Other Outcome Measures:
  • Client Use of Services [ Time Frame: Baseline, 3 month ] [ Designated as safety issue: No ]
    The client use of services Scale is a 49 item measure that assesses access to and use of general health services in the community. This includes hospitalizations, ER visits, Mental Health Services, Substance Abuse Services, Social and Community-based Services, and other trusted locations.

  • Current Medication Use [ Time Frame: Baseline, 3 month ] [ Designated as safety issue: No ]
    The current medication use is a measure with 3 items created to identify any prescribed medications being consumed for mental or emotional problems such as depression, anxiety, or nerves.

  • Satisfaction with Community Services [ Time Frame: Baseline, 3 month ] [ Designated as safety issue: No ]
    The satisfaction with community services is a measure with 5 items (1-very dissatisfied to 5- very satisfied) used to assess the satisfaction of the availability of health and social services in community.

  • Chronic Conditions [ Time Frame: Baseline, 3 month ] [ Designated as safety issue: No ]
    The chronic condition is a standard measure of health problems some people may have (medical, smoking, weight, height, physical activity). There are 23 items in this measure.

  • Current and Past Use of Alcohol / Drugs [ Time Frame: Baseline, 3 month ] [ Designated as safety issue: No ]
    The current and past use of alcohol or drugs is a measure with 13 items created to assess the use of illicit drugs or alcohol abuse.

  • Life Difficulties in Past 3 months [ Time Frame: Baseline, 3 month ] [ Designated as safety issue: No ]
    The life difficulties during the past six months is a 15 item measure created to identify life stress events.

  • Coping Strategies [ Time Frame: Baseline, 3 month ] [ Designated as safety issue: No ]
    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.

  • Social Supports [ Time Frame: Baseline, 3 month ] [ Designated as safety issue: No ]
    The social support survey is a 10 item measure created to help assess various dimensions of social support (emotional, affectionate, and positive social interaction).

  • Employment, work missed for those employed [ Time Frame: Baseline, 3 month ] [ Designated as safety issue: No ]
    The employment questionnaire has 18 items that assesses the employment situation of participants. There are 4 additional items reporting any days missed of work.

  • Income [ Time Frame: Baseline, 3 month ] [ Designated as safety issue: No ]
    The income survey is a 16 item measure created to evaluate the level of income within each household and whether families received income from any government programs.

  • Food Security [ Time Frame: Baseline, 3 month ] [ Designated as safety issue: No ]
    The food security is a 2 item measure created to determine household food security .

  • Fordyce Emotions Questionnaire [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 200
Study Start Date: October 2012
Study Completion Date: June 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resiliency Class

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
See Arm Description
Active Comparator: Case Management
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
See Case Management description

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

B-RICH Phase I, Pilot Inclusion Criteria

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

B-RICH, Phase I Pilot 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

3) Unable to be contacted by phone 4) Unable to attend the weekly resiliency classes

B-RICH Phase II, Randomized Trial Inclusion Criteria

  1. Age 18 or older
  2. 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."
  3. Able to be contacted by phone (voice or text message), e-mail, or Facebook.
  4. Able to participate in the seven, weekly 90-120 minute sessions of the Resiliency Classes
  5. English or Spanish speaker

B-RICH Phase II, Randomized Trial Exclusion Criteria

  1. Under age 18 years
  2. PHQ-8 score of 20 or greater on the baseline interview
  3. PHQ-8 score of 15 or greater and not currently in care and unwilling to get a referral for care
  4. Currently homeless
  5. Has a prior diagnosis of Bipolar Disorder
  6. Has a prior diagnosis of Schizophrenia
  7. Current alcohol and substance abuse
  8. Unable to attend the weekly resiliency classes
  9. Does not currently have a phone, an email address, or a Facebook profile
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698047

Locations
United States, California
Healthy African American Families
Los Angeles, California, United States, 90008
1st African Presbyterian Church
Los Angeles, California, United States, 90047
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90509
Sponsors and Collaborators
University of California, Los Angeles
Los Angeles Biomedical Research Institute
Investigators
Principal Investigator: Bowen Chung, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Bowen Chung, MD, MSHS, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01698047     History of Changes
Other Study ID Numbers: CCF-12-001142, CMCH 12-97088
Study First Received: September 26, 2012
Last Updated: June 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Depressive symptoms
sub-threshold depression
resiliency
Health Promotion
minority health

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 24, 2014