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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01280916
First received: January 12, 2011
Last updated: September 12, 2012
Last verified: September 2012

January 12, 2011
September 12, 2012
October 2008
August 2010   (final data collection date for primary outcome measure)
Percent Days Substance Use [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01280916 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Substance Use Disorder
Behavioral: Mindful Awareness in Body-oriented Therapy
8 weekly sessions of 1.5 hours each delivered to women in substance use disorder treatment
  • Experimental: Mind-body intervention
    Mindful Awareness in Body-oriented Therapy
    Intervention: Behavioral: Mindful Awareness in Body-oriented Therapy
  • No Intervention: Treatment as Usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
March 2011
August 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01280916
33795-C, R21DA024771
No
University of Washington
University of Washington
National Institute on Drug Abuse (NIDA)
Principal Investigator: Cynthia J Price, PhD University of Washington
University of Washington
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP