Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment
Primary Purpose
Substance Use Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mindful Awareness in Body-oriented Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorder
Eligibility Criteria
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
Sites / Locations
- Residence XII
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mind-body intervention
Treatment as Usual
Arm Description
Mindful Awareness in Body-oriented Therapy
Outcomes
Primary Outcome Measures
Percent Days Substance Use
Secondary Outcome Measures
Full Information
NCT ID
NCT01280916
First Posted
January 12, 2011
Last Updated
November 15, 2018
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01280916
Brief Title
Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment
Official Title
Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mind-body intervention
Arm Type
Experimental
Arm Description
Mindful Awareness in Body-oriented Therapy
Arm Title
Treatment as Usual
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindful Awareness in Body-oriented Therapy
Intervention Description
8 weekly sessions of 1.5 hours each delivered to women in substance use disorder treatment
Primary Outcome Measure Information:
Title
Percent Days Substance Use
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia J Price, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Residence XII
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment
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