跳至主要内容
临床试验/NCT00851669
NCT00851669
已完成
2 期

Behavioral Treatment for Alcohol Dependent Women With Co-occurring Depression

University of Rochester1 个研究点 分布在 1 个国家目标入组 91 人2009年4月

概览

阶段
2 期
干预措施
未指定
疾病 / 适应症
Alcohol Dependence
发起方
University of Rochester
入组人数
91
试验地点
1
主要终点
Timeline Follow-back Interview (percentage days abstinent, average drinks per drinking day)
状态
已完成
最后更新
12年前

概览

简要总结

The aim of this study is to evaluate an interpersonally-focused intervention (Interpersonal Psychotherapy) for women with co-occurring alcohol dependence and depression. A sub-protocol has been added to pilot the current study with men with co-occurring alcohol dependence and depression.

详细描述

Co-occurring alcohol dependence and major depression (AD-MD) is a serious and common public health problem, yet one that is largely unaddressed by conventional chemical dependency treatment. Among alcohol dependent patients, co-occurring depression is associated with poorer treatment outcomes, increased risk for relapse, worse long-term social and functional adjustment, and higher probability of dire outcomes such as suicide. Treatment research on AD-MD patients is needed to inform effective practice. This study provides an initial test of the applicability of Interpersonal Psychotherapy for alcohol dependent women with major depression (IPT-ADMD). The goal of the proposed research project is to refine and test a behavioral intervention that addresses women's co-occurring alcohol dependence and depression within a cohesive interpersonal frame. In Phase 1 of the project, IPT-ADMD will be piloted with 15 AD-MD women enrolled in a MICA (mentally-ill chemical abusers) group treatment program. Findings from Phase 1 will be used to refine the treatment, assessment, and therapist training procedures. In Phase 2, a randomized controlled trial with 60 AD-MD women will be conducted 1) to determine IPT-ADMD's feasibility and acceptability as an adjunct to standard MICA group treatment, and 2) to assess the comparative effects of IPT-ADMD to treatment-as-usual individual therapy (TAU-IT). Compared to TAU-IT, IPT-ADMD is hypothesized to lead to greater reductions in women's drinking frequency, drinking intensity, and depressive symptoms, and to improved interpersonal functioning. In addition to the current intervention study comparing IPT-ADMD with TAU-IT, we are piloting IPT-ADMD with men in a sub-protocol of the main study. The target population of the Bridge Program will be men with alcohol dependence and co-occurring major depression. We hypothesize that IPT will be feasible and acceptable and will improve drinking frequency and intensity; depressive symptoms; and interpersonal functioning. The proposed sub-protocol will allow us to determine if future clinical trials of IPT should include both male and female patients with co-occurring alcohol dependence and depression.

注册库
clinicaltrials.gov
开始日期
2009年4月
结束日期
2013年7月
最后更新
12年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Stephanie Gamble

Assistant Professor Department of Psychiatry

University of Rochester

入排标准

入选标准

  • Current Alcohol Dependence and Major Depression

排除标准

  • Bipolar Disorder
  • Psychosis or schizophrenia

结局指标

主要结局

Timeline Follow-back Interview (percentage days abstinent, average drinks per drinking day)

时间窗: Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men

次要结局

  • Beck Depression Inventory(Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men)
  • Hamilton Rating Scale for Depression(Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men)

研究点 (1)

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