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临床试验/NCT00350649
NCT00350649已完成2 期

Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management

Yale University1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2004年12月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
205
试验地点
1
主要终点
Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens

研究概览

简要总结

Cognitive-behavioral coping skills therapy (CBT) is a widely used and recognized treatment that has been empirically validated for a range of substance use disorders, often with emergent effects and continuing improvement even after treatment ends. Treatment retention and compliance are associated with enhanced treatment outcomes in CBT. Contingency management (CM) also has very strong support and is associated with rapid, robust effects on targeted outcomes. Despite their many strengths, neither CBT nor CM is universally effective. It is now essential to seek strategies to maximize and extend the effectiveness of these two approaches and to better understand how these treatments exert their effects.

详细描述

The investigators propose to evaluate targeted strategies to maximize the effectiveness of CBT and CM, respectively. To maximize the effectiveness of CBT, the investigators will evaluate the benefit of adding CM, with reinforcement for session attendance and homework completion, to standard individual CBT for outpatient marijuana abusers, in order to expose participants to more skill training and opportunities for practice of skills. To maximize the effectiveness and durability of CM, we will evaluate the benefit of integrating it with skills training, specifically designed to reduce drop off effects, in order to extend CM's benefits beyond the active treatment period. We propose to conduct a Stage II trial which will: (1) Evaluate the efficacy of four conditions for 160 marijuana dependent outpatients: (a) Standard CBT, (b) CBT with CM reinforcement for attendance and completing homework (CBT+CM/adherence), (c) CM for abstinence alone (CM/abstinence), (d) CM for abstinence integrated with CBT (CM/abstinence+CBT), and (2) Evaluate the longer-term durability and / or delayed emergence of treatment effects after termination of the study treatments through a one-year follow-up. Secondary aims will be to conduct (a) detailed process studies to evaluate whether the proposed enhancements affect proximal and distal outcomes as hypothesized and (b) economic analyses. Study treatments will last 12 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

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
否

入选标准

  • •18-65 year old marijuana dependent
  • •willing to sign consent
  • •no use of prescribed psychotropic drugs
  • •willing to give three individuals as contacts
  • •willing to accept randomization
  • •read and write English (third grade level)

排除标准

  • •unable to commit to 1 year follow up

研究组 & 干预措施

1

Experimental

manualized delivery of CBT by trained clinicians

干预措施: Standard CBT (Behavioral)

2

Active Comparator

CBT with Contingency Management reinforcement for attendance and completing homework (CBT+CM/adherence)

干预措施: CBT+CM/adherence (Behavioral)

3

Experimental

Contingency Management for abstinence alone (CM/abstinence)

干预措施: CM/abstinence (Behavioral)

4

Active Comparator

Contingency Management integrated with CBT (CM/abstinence+CBT)

干预措施: CM/abstinence+CBT (Behavioral)

结局指标

主要结局

Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens

时间窗: 12 weeks

次要结局

  • Economic analysis with use of PACC-SAT(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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