Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse 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: NCT01280916
Recruitment Status : Completed
First Posted : January 21, 2011
Last Update Posted : September 14, 2012
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Washington

Brief Summary:

The primary purpose of this exploratory and developmental study is to evaluate a mind-body intervention for relapse prevention for women in addiction treatment. The proposed intervention, Mindful Awareness in Body-Oriented Therapy (MABT), is a novel mind-body intervention designed to enhance embodiment and to facilitate mindfulness through the combination of massage, body awareness exercises and the acquisition of mindfulness skills. The treatment goals of MABT include reduction of avoidant coping responses, increase of emotional-regulation, and decrease of trauma symptoms through access to and acceptance (vs. avoidance) of sensory and emotional experience. These are thought to be important for relapse prevention given the positive association between stress, negative affect and relapse; and risk of relapse associated with PTSD symptoms. Mind-body interventions in relapse prevention are of increased clinical and scientific interest, particularly for the potential to overcome automatic response patterns that are associated with lapse and relapse in substance use treatment. This proposal falls within the current NIDA research portfolio focus on the development of interventions that will help people better cope with stress, negative affect, and trauma.

Specific Aims:

  • Aim 1: To examine feasibility of recruitment to and retention in MABT as an adjunct to substance abuse treatment. Specifically, to describe a) study enrollment and barriers to recruitment, b) sample characteristics, c) response to randomization, d) session attendance, and e) loss to follow-up.
  • Aim 2: To describe MABT acceptability to study participants and substance abuse treatment staff.
  • Aim 3: To compare the effect of body-oriented therapy plus treatment-as-usual vs. treatment-as-usual only on reported days abstinent for overall substance use and primary drug use among women receiving substance abuse treatment, in order to estimate the effect size. Secondary analyses will examine for intervention effects on related outcomes including days abstinence on biochemical screens for substance use, body connection indicators, avoidant coping, stress reactivity, co-morbid psychological distress, and physical well-being.

Condition or disease Intervention/treatment Phase
Substance Use Disorder Behavioral: Mindful Awareness in Body-oriented Therapy Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment
Study Start Date : October 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: Mind-body intervention
Mindful Awareness in Body-oriented Therapy
Behavioral: Mindful Awareness in Body-oriented Therapy
8 weekly sessions of 1.5 hours each delivered to women in substance use disorder treatment
No Intervention: Treatment as Usual

Primary Outcome Measures :
  1. Percent Days Substance Use [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female
  • enrolled in weeks 1-3 of Residence XII inpatient program
  • plans continued out-patient treatment at Residence XII
  • willing to sign release to contact the Residence XII mental health therapist in the case of concern regarding participant safety and well being
  • willing to forgo (non-study) body therapy between baseline and post-intervention assessment (3 months)
  • willing to accept random assignment to study treatment conditions

Exclusion Criteria:

  • Current domestic violence
  • 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): NCT01280916

United States, Washington
Residence XII
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)
Principal Investigator: Cynthia J Price, PhD University of Washington

Responsible Party: University of Washington Identifier: NCT01280916     History of Changes
Other Study ID Numbers: 33795-C
R21DA024771 ( U.S. NIH Grant/Contract )
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: September 14, 2012
Last Verified: September 2012

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