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临床试验/NCT01189552
NCT01189552已完成不适用

Depression Treatment for Urban Low Income Minority Substance Users

University of North Carolina, Chapel Hill4 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2010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
263
试验地点
4
主要终点
Substance Use

研究概览

简要总结

The objective of the current study is to evaluate the effects of a brief, behavioral activation treatment (the Life Enhancement Treatment for Substance Use; LET'S ACT) on long term outcomes of substance use, HIV risk behaviors and mechanisms of treatment response (depressive symptoms, environmental reward, behavioral activation).

详细描述

Approximately 22% of substance users suffer from elevated depressive symptoms, which is associated with higher rates of substance abuse treatment dropout, relapse to substance use, and HIV risk behavior. Few interventions targeting reinforcement principles have been developed to meet the specific needs of treatment seeking substance users. One approach that may be especially appropriate in this regard is behavioral activation (BA), which aims to increase individuals' engagement in pleasant events, thereby increasing contact with positive reinforcement and decreasing the frequency of aversive events. BA has been shown to be efficacious in the treatment of depression, and this uncomplicated and straightforward approach may be especially appropriate for the specific needs of an inner city low income substance abusing sample. Further, BA compliments standard substance abuse treatment in several key practical and theoretical ways as it is more easily adopted by staff in these settings, more time efficient (e.g., fewer and shorter sessions, group format), more easily understood by patients who suffer from cognitive limitations due to low education level and chronic drug use, and can incorporate aspects of sobriety into its treatment components. In an initial Stage 1 development project, a version of BA, the Life Enhancement Treatment for Substance Use (LETS ACT), was developed and specifically tailored for inner-city low income minority substance users with elevated depressive symptoms. Results demonstrated that LETS ACT led to a significantly greater reduction in self-reported depressive symptoms and a significant increase in enjoyment and reward value of activities as compared to the TAU control group (Daughters et al., 2008). While preliminary findings prove promising, many questions remain unanswered and several extensions of this work are necessary, including an assessment of post treatment substance use and HIV risk behavior, a contact-matched control, and a larger sample size to allow for more complex analyses of the mechanisms underlying these outcomes. Thus, the objective of the present proposal is to follow-up on our previous Stage 1 treatment development efforts and small scale randomized control trial (RCT) with a fully-powered Stage 2 RCT comparing LETS ACT to nondirective therapy (NDT) among a sample of 263 low income depressed substance users currently receiving residential substance abuse treatment in inner-city Washington, DC.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • between 18 and 65 years of age
  • beginning their last month of residential treatment

排除标准

  • limited mental competency [Mini Mental State Examination score < 23]
  • psychosis
  • the use of psychotropic medication for < 3 months
  • the inability to give informed, voluntary, written consent to participate

结局指标

主要结局

Substance Use

时间窗: baseline to a 12-month post treatment follow up period

Urine Screen and Timeline Followback

Beck Depression Inventory (BDI-II; Beck et al., 1996)

时间窗: BDI-II will be evaluated from baseline to a 12-month follow up period

The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms.

次要结局

  • Reward Probability Index (RPI)(baseline to a 12-month post treatment follow up period)
  • Behavioral Activation for Depression Scale (BADS)(baseline to a 12-month post treatment follow up period)

研究者

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

Stacey Daughters, PhD

Associate Professor

University of North Carolina, Chapel Hill

研究点 (4)

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