Clinical Trials Directory

Trials / Completed

CompletedNCT01960036

Body-oriented Therapy for Women in SUD Treatment

Body-oriented Therapy for Womens Substance Use Disorder Treatment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
217 (actual)
Sponsor
University of Washington · Academic / Other
Sex
Female
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMindful Awareness in Body-oriented Therapy
BEHAVIORALWomens Health Education

Timeline

Start date
2014-01-01
Primary completion
2017-09-15
Completion
2018-06-30
First posted
2013-10-10
Last updated
2018-10-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01960036. Inclusion in this directory is not an endorsement.