Study Results
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Basic Information
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COMPLETED
NA
217 participants
INTERVENTIONAL
2014-01-31
2018-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment as usual (TAU)
Usual intensive outpatient treatment for substance use disorders
No interventions assigned to this group
Mindful Awareness in Body-oriented Therapy (MABT)
A mind-body intervention to teach interoceptive skills for self-care.
Mindful Awareness in Body-oriented Therapy
Womens Health Education
A comparative arm to control for time and attention that involves education about the human body relevant to women's health.
Womens Health Education
Interventions
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Mindful Awareness in Body-oriented Therapy
Womens Health Education
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
FEMALE
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Washington
OTHER
Responsible Party
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Cynthia Price
Research Associate Professor
Principal Investigators
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Cynthia J Price, PhD, MA
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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References
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Price CJ, Wells EA, Donovan DM, Rue T. Mindful awareness in body-oriented therapy as an adjunct to women's substance use disorder treatment: a pilot feasibility study. J Subst Abuse Treat. 2012 Jul;43(1):94-107. doi: 10.1016/j.jsat.2011.09.016. Epub 2011 Nov 25.
Price CJ, Wells EA, Donovan DM, Brooks M. Implementation and acceptability of Mindful Awareness in Body-oriented Therapy in women's substance use disorder treatment. J Altern Complement Med. 2012 May;18(5):454-62. doi: 10.1089/acm.2011.0126. Epub 2012 Apr 23.
Price CJ, Crowell SE. Respiratory sinus arrhythmia as a potential measure in substance use treatment--outcome studies. Addiction. 2016 Apr;111(4):615-25. doi: 10.1111/add.13232. Epub 2016 Jan 5.
Other Identifiers
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46102-J
Identifier Type: -
Identifier Source: org_study_id
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