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临床试验/NCT01135264
NCT01135264已完成不适用

Gambling Addiction: Treatment Mediators and Moderators

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2009年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
1
主要终点
patient retention

研究概览

简要总结

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).

详细描述

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, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

CBT

Active Comparator

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.

干预措施: CBT (Behavioral)

CMBT

Experimental

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)

干预措施: CMBT (Behavioral)

结局指标

主要结局

patient retention

时间窗: 60 weeks

Retention will be measured by the number of treatment sessions attended

次要结局

  • gambling behavior(60 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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