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临床试验/NCT01960036
NCT01960036已完成不适用

Body-oriented Therapy for Womens Substance Use Disorder Treatment

University of Washington2 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2014年1月最近更新:
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
217
试验地点
2
主要终点
Timeline Follow-back Interview (TLFB)

研究概览

简要总结

The long-term objective of this study is to improve women's substance use disorder (SUD) treatment. The immediate project goal is to test the efficacy of an innovative mind-body intervention, Mindful Awareness in Body-Oriented Therapy (MABT) to reduce substance use relapse among women in SUD treatment.

A novel mind-body approach, MABT combines a hands-on (manual) approach with mind-body psycho-education approaches of interoceptive training and mindfulness to develop somatically-based self-care skills and to facilitate emotion regulation. A three-group, randomized clinical trial using repeated measures, this project will enroll and randomize 225 women to one of three groups, MABT + Treatment-as-usual (TAU) (n=75), TAU only (n=75), and Women's Health Education (WHE) + TAU (to control for time and attention) (n=75). Study conditions will be compared at baseline, post-intervention, and at 6 and 12 month follow-up.

The primary aim is to test the hypothesis that MABT will result in reduced substance use and related health outcomes compared to TAU and to WHE+ TAU at 12 month follow-up. The second aim is to examine hypothesized underlying mechanisms of MABT. Female outpatients in two diverse community treatment facilities, serving racially diverse patients, will be recruited for study participation. This study builds on promising preliminary evidence of MABT feasibility and acceptability in substance use disorder treatment for women, and addresses the need for more clinical research aimed at improving SUD treatment outcomes for women.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female, 2) enrolled in intensive outpatient (IOP) with at least 8 weeks remaining in planned SUD treatment program, 3) agrees to forgo (non-study) manual therapies (e.g.,massage) and mind-body therapies (e.g., mindfulness meditation) for 3 months (baseline to post-test); 4) willing to sign release for access of electronic medical records; 5) fluent in English; and 6) can attend MABT and WHE sessions when offered.

排除标准

  • ) untreated psychotic diagnosis or symptoms, using modules from the MINI International Neuropsychiatric Interview; 2) unwilling or unable to remain in treatment for the duration of the trial (includes planned relocation, pending incarceration, planned surgical procedures, etc.); 3) cognitive impairment, to be assessed with an informed consent quiz, followed by the Mini-Mental Status Exam (MMSE), a common screening tool in SUD treatment studies, if there is demonstrated difficulty comprehending the consent; or 4) currently pregnant.

研究组 & 干预措施

Treatment as usual (TAU)

No Intervention

Usual intensive outpatient treatment for substance use disorders

Mindful Awareness in Body-oriented Therapy (MABT)

Experimental

A mind-body intervention to teach interoceptive skills for self-care.

干预措施: Mindful Awareness in Body-oriented Therapy (Behavioral)

Womens Health Education

Active Comparator

A comparative arm to control for time and attention that involves education about the human body relevant to women's health.

干预措施: Womens Health Education (Behavioral)

结局指标

主要结局

Timeline Follow-back Interview (TLFB)

时间窗: Change from baseline in TLFB assessed at different time points (3,6 and 12 months)

Collects self-report substance use information using a calendar method

次要结局

未报告次要终点

研究者

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

Cynthia Price

Research Associate Professor

University of Washington

研究点 (2)

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