Building Resiliency and Increasing Community Hope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 3
- 主要终点
- Depressive symptom count as measured by the Patient Health Questionnaire 8
研究概览
简要总结
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.
详细描述
B-RICH proposes to pilot and then conduct a randomized, single blind trial of a psychosocial intervention called a "Resiliency Class" (RC), to provide depression education and health promotion to individuals with depressive symptoms, by training non-professionals to offer this class to clients receiving services within diverse community settings (e.g. health care clinic, church, community advocacy organization, social services agency). This class is not designed to be therapy, but rather is designed as a class that is informed on cognitive behavioral therapy (CBT) principles used to address depressive symptoms, on how to improve mood, and to enhance resiliency in the face of stress.
The Resiliency Class is a manualized, CBT informed, seven session, psycho-educational intervention designed to be delivered by non-licensed teachers in both English and Spanish to address depressive symptoms. Each session is designed to be between 90-120 minutes. Some of the goals of the RC are: 1) to provide psycho-education on mood and depressive symptoms; 2) to provide this education through teachers who are not health or mental healthcare professionals in order to improve access to depression education and to offer approaches to improve depressive symptoms; 3) to deliver this class in non-health care or mental health care settings like churches or in trusted community locations (e.g. parks and recreation, primary care, social services agencies, job retraining centers, senior centers) instead of as "therapy" or in mental health settings so that individuals would not feel stigmatized; 4) to design the manual so that it will be usable by class participants with low literacy levels in both English and Spanish.
The specific aims for this study are to:
- Pilot a revised resiliency class intervention led by non-professionals in 20 individuals with depressive symptoms for acceptability;
- Revise the resiliency class intervention based on therapist's experience from the pilot based on feedback from both the instructors and the pilot class participants;
- Conduct a randomized, single blind trial of the resiliency class (study group) versus case management social services assessment and referrals (control group) to assess their differential impact on depressive symptoms in 400 study participants (200 in each arm of the study).
There will be several steps to the implementation of the B-RICH Study. Phase I
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •B-RICH Phase I, Pilot Inclusion Criteria
- •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
- •B-RICH, Phase I Pilot
排除标准
- •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
- •B-RICH Phase II, Randomized Trial Inclusion Criteria
- •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
- •B-RICH Phase II, Randomized Trial Exclusion Criteria
- •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
- •Current alcohol and substance abuse
- •Unable to attend the weekly resiliency classes
- •Does not currently have a phone, an email address, or a Facebook profile
研究组 & 干预措施
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"
干预措施: Resiliency Class (Behavioral)
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.
干预措施: Case Management (Other)
结局指标
主要结局
Depressive symptom count as measured by the Patient Health Questionnaire 8
时间窗: Change from Baseline in Depressive Symptoms at 3 months
The Patient Health Questionnaire (PHQ) 8 is a standard measure of depressive symptoms.
次要结局
- mental health related quality of life (MCS-12) from the Short Form 12 item - Health Survey(Baseline, 3 months)
研究者
Bowen Chung, MD, MSHS
Associate Professor-in-Residence
University of California, Los Angeles