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临床试验/NCT01438346
NCT01438346已完成不适用

A Pilot Study of Two Group-based Intervention Programs for Patients With Substance Abuse Problems

University of Utah2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2011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
38
试验地点
2
主要终点
Change from baseline in the measure of the Penn Alcohol and Craving Scale

研究概览

简要总结

This pilot project will evaluate a new mind-body intervention called Mind-Body Bridging (MBB) for reducing substance abuse problems in women who are undergoing a substance abuse treatment program. The main hypothesis is that MBB will be more effective than the control (standard) intervention program in helping people reduce their craving for illicit substances and/or alcohol.

详细描述

This is a randomized clinical pilot study in which MBB will be compared with a standard treatment program for substance abuse. Both groups will run concurrently over the course of a 10-week period, twice per week.

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 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Substance abuse or dependence
  • Resident/day client in the House of Hope substance abuse treatment program
  • Minimum stay in treatment at House of Hope for 3.5 months
  • Fluent in English

排除标准

  • Psychosis
  • Suicide risk
  • Significant withdrawal risk
  • Severe, unstable depression
  • Requires intensive mental health treatment
  • Cognitive impairment

研究组 & 干预措施

Mind-body Bridging (MBB)

Experimental

Participants in the experimental Mind-Body Bridging (MBB) group, in addition to their usual treatment for substance abuse, will additionally receive instruction on the basics of MBB, and will learn MBB techniques to help deal with their cravings and comorbid psychological conditions. A workbook will be incorporated into the curriculum to provide MBB participants with daily exercises and activities to help facilitate adherence to the MBB program.

干预措施: Mind-body Bridging (Behavioral)

Substance Abuse Education (SED)

Active Comparator

The Substance Abuse Education (SED) group will serve as the control intervention in which participants will receive instruction on a variety of topics included in the substance abuse treatment program curriculum. These will include, but are not limited to, information about anger management, smoking cessation, women's issues, and stress management, and approaches to help reduce cravings. Each week the TAU group will meet and a House of Hope (HOH) clinical staff member will discuss the above and related issues and how these may help individuals deal with their substance abuse and related psychological issues.

干预措施: Substance Abuse Education (Behavioral)

结局指标

主要结局

Change from baseline in the measure of the Penn Alcohol and Craving Scale

时间窗: Week 5 and Week 11

Change from baseline in the extent of drug and alcohol craving at Week 5 and Week 11, as measured by a modified version of the Penn Alcohol and Craving Scale

Change from baseline in Alcohol and Drug Use Consequences Scale

时间窗: Week 5 and Week 11

Change from baseline in the measure of alcohol and drug consequences at Week 5 and Week 11, as measured by Alcohol and Drug Use Consequences Scale

次要结局

  • Depression(Pre (Baseline) Mid (Week 5), Post (Week 11))
  • Mindfulness(Pre (Baseline) Mid (Week 5), Post (Week 11))
  • Sleep(Pre (Baseline) Mid (Week 5), Post (Week 11))
  • Well-being(Weekly for 11 weeks)
  • Self-Compassion(Pre (Baseline) Mid (Week 5), Post (Week 11))
  • Subjective distress(Pre (Baseline) Mid (Week 5), Post (Week 11))

研究者

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

Yoshio Nakamura

Research Assistant Professor

University of Utah

研究点 (2)

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