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临床试验/NCT01698047
NCT01698047已完成不适用

Building Resiliency and Increasing Community Hope

University of California, Los Angeles6 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
6
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:

  1. Pilot a revised resiliency class intervention led by non-professionals in 20 individuals with depressive symptoms for acceptability;
  2. 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;
  3. 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

入选标准

  • 未提供

排除标准

  • 未提供

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bowen Chung, MD, MSHS

Associate Professor-in-Residence

University of California, Los Angeles

研究点 (6)

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