Body-oriented Therapy for Women in SUD Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cynthia Price, University of Washington
ClinicalTrials.gov Identifier:
NCT01960036
First received: October 8, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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 Intervention
Substance Use Disorder
Behavioral: Mindful Awareness in Body-oriented Therapy
Behavioral: Womens Health Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Body-oriented Therapy for Womens Substance Use Disorder Treatment

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Timeline Follow-back Interview (TLFB) [ Time Frame: Change from baseline in TLFB assessed at different time points (3,6 and 12 months) ] [ Designated as safety issue: No ]
    Collects self-report substance use information using a calendar method


Estimated Enrollment: 225
Study Start Date: January 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960036

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: cynthia Price, PhD    206-685-4739    cynthiap@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Cynthia J Price, PhD, MA University of Washington
  More Information

Publications:
Responsible Party: Cynthia Price, Research Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01960036     History of Changes
Other Study ID Numbers: R01DA033324
Study First Received: October 8, 2013
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 31, 2014