Building Resiliency and Increasing Community Hope (BRICH)
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.
|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|
- 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.
- 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.
- 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.
|Study Start Date:||October 2012|
|Study Completion Date:||June 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698047
|United States, California|
|1st African Presbyterian Church|
|Los Angeles, California, United States, 90047|
|Healthy African American Families|
|Los Angeles, California, United States, 90008|
|Los Angeles Biomedical Research Institute|
|Torrance, California, United States, 90509|
|Principal Investigator:||Bowen Chung, MD||University of California, Los Angeles|