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临床试验/NCT01189799
NCT01189799已完成不适用

Motivational Therapy for Substance Users With Depression

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2007年9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
36
试验地点
2
主要终点
Change in Substance Use

研究概览

简要总结

The primary objective of the study is to test the incremental efficacy and outcomes of an aftercare program of Cognitive Behavioral Therapy combined with motivational therapy (CBT-MT) relative to treatment as usual (TAU) in improving depression, substance use, and healthcare outcomes in a population with drug dependence and comorbid major depressive disorder (MDD). The investigators expect that among drug-dependent patients with comorbid MDD, CBT-MT will yield better clinical outcomes relative to TAU in reducing depressive symptoms and substance use and improving healthcare outcomes during treatment.

Secondary Objectives:

  1. Test efficacy and outcomes of CBT-MT and TAU
  2. Evaluate the differential effect of CBT-MT versus TAU on HIV-risk behavior of participants,
  3. To evaluate the impact of cognitive functioning on treatment retention and outcomes, and
  4. To explore additional psychosocial, demographic, and diagnostic factors (e.g., age, gender, education level, motivation for change, social support) that may be associated with treatment outcome and retention in this high need population.

详细描述

This study will include approximately 80 participants randomized to either 12 weeks of motivational therapy or treatment as usual. Both treatments will meet once weekly for 60 minutes. Participants will be recruited from the Adult Partial Hospitalization program at University of California, Los Angeles. During the active treatment phase, participants will attend clinic weekly for collection of data and urine specimens.

  1. For those randomly assigned to CBT-MT, they will meet with a therapist in a group format for 60-minute sessions once weekly.

a. Each CBT-MT session will begin with 20 minutes of motivational therapy (MT), followed by 40 minutes of CBT content. 2. Those randomly assigned to TAU, they will attend a weekly 60-minute Dual Recovery Anonymous self-help group.

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
None

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

  • Age 18 or over
  • DSM-IV diagnosis of Substance Dependence (cannabis, stimulant, opioid, or prescription drug) or DSM-IV diagnosis of Alcohol Dependence and abuse of cannabis, stimulant, opioid, or prescription drug
  • Diagnostic and Statistical Manual -IV diagnosis of lifetime Major Depressive Disorder (MDD)
  • BDI-II score of 13 or greater

排除标准

  • Presence of life threatening or unstable medical illness
  • Lack of proficiency in English
  • Current homelessness (unless residing in a recovery home for which contact information can be provided)
  • Psychiatric symptoms warranting safety concerns or inpatient treatment, including acute suicide risk
  • Present diagnosis of Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder.

结局指标

主要结局

Change in Substance Use

时间窗: weekly during active phase and through study completion, up to 6 months

* Participants will provide a sample for a urine drug screen (UDS). * Participants will also self report substance use.

Change in Depression symptoms

时间窗: weekly during intervention and through study completion, up to 6 months

-Participants will complete the Beck's Depression Inventory (BDI) to measure changes in depression symptoms over time.

Change in Healthcare utilization

时间窗: weekly and at follow up, up to 6 months

-Participants will self report use of ancillary treatment and healthcare services including ER visits and hospitalizations.

次要结局

  • Efficacy and outcomes of CBT-MT and TAU(Baseline, end of treatment, and at follow up, up to 6 months)
  • HIV-risk behavior of participants(Baseline, end of treatment and follow up, up to 6 months)
  • Cognitive functioning(Baseline and end of treatment at 3 months post treatment)

研究者

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

Suzette Glasner-Edwards

Principal Investigator

University of California, Los Angeles

研究点 (2)

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