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Cognitive-Motivational Behavior Therapy for Pathological Gamblers

2017年1月12日 更新者:New York State Psychiatric Institute

Gambling Addiction: Treatment Mediators and Moderators

In the proposed two-arm randomized controlled trial, 200 patients meeting DSM-IV criteria for PG will be randomized to 12 sessions of Cognitive-Motivational Behavior Therapy (CMBT) or to Cognitive Behavior Therapy (CBT).

研究概览

地位

完全的

条件

详细说明

CMBT has been developed by our team over the last five years, and has shown very promising results in a small, NIMH-funded randomized pilot trial (R21 MH 064568). We will assess patients biweekly during the active treatment phase and follow them for 12 months after the end of treatment to obtain data on long-term treatment outcome. We hypothesize that CMBT will show higher efficacy and retention than CBT in the treatment phase, and that gains will be maintained at a higher rate during follow-up.

A second major purpose of the proposed study is to elucidate the presumed mechanisms of change by examining potential mediators (readiness to change, irrational beliefs about gambling, coping skills, therapeutic alliance) and moderators (psychiatric comorbidity with Axis I and II disorders, family history of PG, impulsivity, and baseline motivation to change) of treatment response. A better understanding of how the proposed interventions work will help advance the science and treatment of PG and will be helpful in the future refinement and adaptation of CMBT. Identifying patient subgroups for which the intervention is particularly effective is essential for rational treatment selection. Thus, the immediate goal of the project is to compare CBMT versus CBT for the treatment of PG. A long-term goal of the proposed research is to establish effective treatment procedures that reduce the considerable individual and social costs of PG.

研究类型

介入性

注册 (实际的)

170

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10032
        • New York Psychiatric Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • pathological gambling
  • be able to read, understand and sign an informed consent form prior to any procedure and must be willing to comply with all study procedures and timelines

Exclusion Criteria:

  • to meet DSM-IV criteria for comorbid substance use disorders in the last six months
  • current comorbid psychiatric conditions which require treatment and are not clearly secondary to pathological gambling
  • psychotropic medication

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:CBT
The CBT treatment developed by Ladouceur (Consultant) will serve as control condition (outline of published treatment manual by Ladouceur & Lachance, 2006. This treatment served as a model for the cognitive-behavioral component in CMBT and has received empirical support in two studies from Ladouceur's lab (Sylvain et al., 1997; Ladouceur et al., 2004). It places strong emphasis on cognitive correction of erroneous beliefs about gambling and also focuses on coping skills training and relapse prevention. CBT also lasts 12 weekly sessions.
The CBT treatment developed by Ladouceur (Consultant) will serve as control condition (outline of published treatment manual by Ladouceur & Lachance, 2006. This treatment served as a model for the cognitive-behavioral component in CMBT and has received empirical support in two studies from Ladouceur's lab (Sylvain et al., 1997; Ladouceur et al., 2004). It places strong emphasis on cognitive correction of erroneous beliefs about gambling and also focuses on coping skills training and relapse prevention. CBT also lasts 12 weekly sessions.
实验性的:CMBT
We used the NIMH-funded R21 mechanism to develop and test the CMBT intervention (Wulfert et al., 2003, 2005; 2006). Treatment will be implemented in 12 weekly sessions (3 motivational enhancement sessions, 8 sessions of cognitive-behavioral treatment, 1 session of relapse prevention)
We used the NIMH-funded R21 mechanism to develop and test the CMBT intervention (Wulfert et al., 2003, 2005; 2006). Treatment will be implemented in 12 weekly sessions (3 motivational enhancement sessions, 8 sessions of cognitive-behavioral treatment, 1 session of relapse prevention)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
patient retention
大体时间:60 weeks
Retention will be measured by the number of treatment sessions attended
60 weeks

次要结果测量

结果测量
措施说明
大体时间
gambling behavior
大体时间:60 weeks
Our primary measure will be money lost gambling. Secondary measures will include days gambled; scores on the PG-YBOCS, proportion of patients meeting diagnosis of PG and of those having achieved abstinence.
60 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Carlos Blanco, M.D.、New York Psychiatric Institute

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年8月1日

初级完成 (实际的)

2016年6月1日

研究完成 (实际的)

2016年6月1日

研究注册日期

首次提交

2010年6月1日

首先提交符合 QC 标准的

2010年6月1日

首次发布 (估计)

2010年6月2日

研究记录更新

最后更新发布 (实际的)

2017年3月24日

上次提交的符合 QC 标准的更新

2017年1月12日

最后验证

2017年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • #5946/6970R
  • 1R01MH082773-01A1 (美国 NIH 拨款/合同)
  • 1R01MH082733-01A1 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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