Body-oriented Therapy for Women in SUD Treatment
|ClinicalTrials.gov Identifier: NCT01960036|
Recruitment Status : Active, not recruiting
First Posted : October 10, 2013
Last Update Posted : October 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Substance Use Disorder||Behavioral: Mindful Awareness in Body-oriented Therapy Behavioral: Womens Health Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||219 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Body-oriented Therapy for Womens Substance Use Disorder Treatment|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||September 15, 2017|
|Estimated Study Completion Date :||June 2018|
No Intervention: Treatment as usual (TAU)
Usual intensive outpatient treatment for substance use disorders
Experimental: Mindful Awareness in Body-oriented Therapy (MABT)
A mind-body intervention to teach interoceptive skills for self-care.
|Behavioral: Mindful Awareness in Body-oriented Therapy|
Active Comparator: Womens Health Education
A comparative arm to control for time and attention that involves education about the human body relevant to women's health.
|Behavioral: Womens Health Education|
- Timeline Follow-back Interview (TLFB) [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960036
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Cynthia J Price, PhD, MA||University of Washington|