Body-oriented Therapy for Women in SUD Treatment

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT01960036

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

217

Enrollment

Location

Arms

53.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorder	Behavioral: Mindful Awareness in Body-oriented Therapy Behavioral: Womens Health Education	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

217 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Body-oriented Therapy for Womens Substance Use Disorder Treatment

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Sep 15, 2017

Actual Study Completion Date :

Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

1. 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.

Exclusion Criteria:

) 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.