Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment

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.

Study Overview

• Status: Completed
• Conditions: Substance Use Disorder
• Intervention / Treatment: Behavioral: Mindful Awareness in Body-oriented Therapy

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Kirkland, Washington, United States, 98034
      • Residence XII

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Treatment as Usual
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Days Substance Use	9 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Cynthia J Price, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: January 12, 2011
• First Submitted That Met QC Criteria: January 19, 2011
• First Posted (ESTIMATE): January 21, 2011

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 33795; R21DA024771 (NIH)