Behavioral Treatment for Substance Abuse
2016年12月1日 更新者：Yoshio Nakamura、University of Utah
A Pilot Study of Two Group-based Intervention Programs for Patients With Substance Abuse Problems
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
38
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
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Utah
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Salt Lake City、Utah、美国、84102
- House of Hope
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Salt Lake City、Utah、美国、84112
- Pain Research Center, Anesthesiology, University of Utah
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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 55年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Psychosis
- Suicide risk
- Dementia
- Significant withdrawal risk
- Severe, unstable depression
- Requires intensive mental health treatment
- Cognitive impairment
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Substance Abuse Education (SED)
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.
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10 weeks of usual care for substance abuse.
其他名称：
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实验性的：Mind-body Bridging (MBB)
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.
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Two sessions per week for 10 weeks, besides usual care treatment for substance abuse.
其他名称：
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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 |
|---|---|---|
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Change from baseline in the measure of the Penn Alcohol and Craving Scale
大体时间：Week 5 and Week 11
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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
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Week 5 and Week 11
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Change from baseline in Alcohol and Drug Use Consequences Scale
大体时间：Week 5 and Week 11
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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
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Week 5 and Week 11
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Subjective distress
大体时间：Pre (Baseline) Mid (Week 5), Post (Week 11)
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Impact of Events Scale - Revised (IES-R) is a 22-item self-report measure that assesses subjective distress caused by traumatic events.
The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Depression
大体时间：Pre (Baseline) Mid (Week 5), Post (Week 11)
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The Center for Epidemiologic Studies Depression Scale is one of the most common screening tests to determine an individual's depression quotient.
The test measures depressive feelings and behaviors during the past week.
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Sleep
大体时间：Pre (Baseline) Mid (Week 5), Post (Week 11)
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The Medical Outcomes Study Sleep Scale (MOS-SS) provides an index of sleep problems and incorporates six sleep scale scores: 1) sleep disturbance, 2) sleep adequacy, 3) daytime somnolence, 4) snoring, 5) waking up short of breath with a headache, and 6) quantity of sleep.
The MOS-SS is similar to the Pittsburgh Sleep Quality Index (PSQI) developed at the same time, which includes more questions about sleep disturbance with seven more items overall.
The 1-week assessment is adapted from the normal 4-week retrospective assessment.
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Mindfulness
大体时间：Pre (Baseline) Mid (Week 5), Post (Week 11)
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The Five-facet Mindfulness Questionnaire (FFMQ) comprises five clear, interpretable facets of mindfulness: acting with awareness, observing, describing, non-judging, non-reacting.
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Self-Compassion
大体时间：Pre (Baseline) Mid (Week 5), Post (Week 11)
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Self compassion is measured by the Self-Compassion Scale that comprises 26 items.
Self-compassion is an emotionally positive self-attitude that should protect against the negative consequences of self-judgment, isolation, and rumination (such as depression).
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Well-being
大体时间：Weekly for 11 weeks
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The Well-Being Index (WBI)is a 5-item scale developed and validated by the World Health Organization Collaborating Centre in Mental Health.
The WBI will be used to assess whether participants show any changes in general well-being.
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Weekly for 11 weeks
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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：Yoshi Nakamura, Ph.D.、University of Utah
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
2011年8月1日
初级完成 (实际的)
2012年8月1日
研究完成 (实际的)
2012年8月1日
研究注册日期
首次提交
2011年9月16日
首先提交符合 QC 标准的
2011年9月20日
首次发布 (估计)
2011年9月22日
研究记录更新
最后更新发布 (估计)
2016年12月2日
上次提交的符合 QC 标准的更新
2016年12月1日
最后验证
2016年12月1日
更多信息
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.