Body-oriented Therapy for Women in SUD Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01960036
Recruitment Status : Active, not recruiting
First Posted : October 10, 2013
Last Update Posted : May 1, 2018
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Cynthia Price, 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.

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 : 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
Study Start Date : January 2014
Actual Primary Completion Date : September 15, 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Women's Health

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01960036

United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)
Principal Investigator: Cynthia J Price, PhD, MA University of Washington

Responsible Party: Cynthia Price, Research Associate Professor, University of Washington Identifier: NCT01960036     History of Changes
Other Study ID Numbers: 46102-J
R01DA033324 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by Cynthia Price, University of Washington:
Substance Use Disorders
Complementary Therapies
Mind-Body Therapies
Behavior and Behavior Mechanisms

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders