Body-oriented Therapy for Women in SUD Treatment
- Conditions
- Substance Use Disorder
- Interventions
- Behavioral: Mindful Awareness in Body-oriented TherapyBehavioral: Womens Health Education
- Registration Number
- NCT01960036
- Lead Sponsor
- University of Washington
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 217
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- 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.
- ) 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindful Awareness in Body-oriented Therapy (MABT) Mindful Awareness in Body-oriented Therapy A mind-body intervention to teach interoceptive skills for self-care. Womens Health Education Womens Health Education A comparative arm to control for time and attention that involves education about the human body relevant to women's health.
- Primary Outcome Measures
Name Time Method Timeline Follow-back Interview (TLFB) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Washington
🇺🇸Seattle, Washington, United States