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

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT01280916
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
46
1
2
28.9
1.6

Study Details

Study Description

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
  • Behavioral: Mindful Awareness in Body-oriented Therapy
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel 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 :
Oct 1, 2008
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Percent Days Substance Use [9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Residence XII Kirkland Washington United States 98034

Sponsors and Collaborators

  • University of Washington
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Cynthia J Price, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cynthia Price, Professor: School of Nursing, University of Washington
ClinicalTrials.gov Identifier:
NCT01280916
Other Study ID Numbers:
  • 33795
  • R21DA024771
First Posted:
Jan 21, 2011
Last Update Posted:
Nov 19, 2018
Last Verified:
Nov 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2018