Hybrid Effectiveness-Implementation Trial to Evaluate a Scalable, Peer-Delivered Intervention for Depression Among People With Substance Use Disorder in a Certified Community Behavioral Health Clinic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Change in Hamilton Depression Rating Scale
研究概览
简要总结
Low-income individuals have limited access to evidence-based interventions for mental health. Peer recovery specialists, individuals in recovery from mental health and/or substance use problems, have the potential to increase access to evidence-based interventions for individuals from low-resource communities, particularly when trained and supervised in models that are acceptable and feasible in these communities. This study will examine the effectiveness and implementation potential of a peer-delivered evidence-based intervention (Behavioral Activation) among individuals receiving services from a community-based treatment setting providing integrated physical and behavioral healthcare.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years old or older
- •Report clinically-significant symptoms of depression, as indexed by a score of 8+ on the PHQ-9.
排除标准
- •Active, under treated psychotic symptoms or mania that would interfere with participation in study procedures
- •Inability to provide informed consent and/or complete procedures in English
研究组 & 干预措施
Behavioral Activation
Peer Activate is an adapted behavioral activation (BA) intervention, developed for delivery by peer recovery specialists to reduce rates of depressive symptoms and substance use. BA focuses on increasing positive reinforcement through engaging in adaptive, valued behaviors. BA has been found to be effective in improving substance use outcomes and decreasing depressive symptoms among low-income individuals with SUD. Peer Activate includes 6 weekly sessions with up to 6 additional booster sessions.
干预措施: Peer Activate (Behavioral)
Enhanced Treatment as Usual
Enhanced treatment as usual (ETAU) involves peer-delivered non-directive support, including facilitated linkages to care and non evidence-based intervention approaches typically used by peer recovery specialists.
干预措施: Peer-delivered non-specific services (Behavioral)
结局指标
主要结局
Change in Hamilton Depression Rating Scale
时间窗: Baseline, post-intervention (approximately 3 months after baseline), 6- and 12-month follow-up
The Hamilton Depression Rating Scale (HAM-D) is a structured interview regarding patients' symptoms of depression and functional impairment. The HAM-D will be administered by research assistants under the supervision of the MPI (Felton) at baseline, post-intervention, 6- and 12-month follow-up. The measure is widely used in depression and substance use treatment studies and has excellent psychometric properties. Nine items are scored 0-4 and 8 items are scored 0-2, with higher scores reflecting greater levels of depressive symptoms. A total score will be calculated by summing each other items. Summed total scores can range from 0-52, with higher values reflecting greater depression.
次要结局
- Change in Patient Health Questionnaire-9(Baseline, post-intervention (approximately 3 months after baseline), 6- and 12-month follow-up)
- Change in Short Inventory of Problems(Baseline, post-intervention (approximately 3 months after baseline), 6- and 12-month follow-up)
研究者
Julia Felton
Associate Professor
Wayne State University