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Body-oriented Therapy for Women in SUD Treatment

Primary Purpose

Substance Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful Awareness in Body-oriented Therapy
Womens Health Education
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorder focused on measuring Substance Use Disorders, Complementary Therapies, Women, Mind-Body Therapies, Behavior and Behavior Mechanisms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 1) female, 2) enrolled in intensive outpatient (IOP) with at least 8 weeks remaining in planned SUD treatment program, 3) agrees to forgo (non-study) manual therapies (e.g.,massage) and mind-body therapies (e.g., mindfulness meditation) for 3 months (baseline to post-test); 4) willing to sign release for access of electronic medical records; 5) fluent in English; and 6) can attend MABT and WHE sessions when offered.

Exclusion Criteria:

  • ) untreated psychotic diagnosis or symptoms, using modules from the MINI International Neuropsychiatric Interview; 2) unwilling or unable to remain in treatment for the duration of the trial (includes planned relocation, pending incarceration, planned surgical procedures, etc.); 3) cognitive impairment, to be assessed with an informed consent quiz, followed by the Mini-Mental Status Exam (MMSE), a common screening tool in SUD treatment studies, if there is demonstrated difficulty comprehending the consent; or 4) currently pregnant.

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Treatment as usual (TAU)

Mindful Awareness in Body-oriented Therapy (MABT)

Womens Health Education

Arm Description

Usual intensive outpatient treatment for substance use disorders

A mind-body intervention to teach interoceptive skills for self-care.

A comparative arm to control for time and attention that involves education about the human body relevant to women's health.

Outcomes

Primary Outcome Measures

Timeline Follow-back Interview (TLFB)
Collects self-report substance use information using a calendar method

Secondary Outcome Measures

Full Information

First Posted
October 8, 2013
Last Updated
October 11, 2018
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01960036
Brief Title
Body-oriented Therapy for Women in SUD Treatment
Official Title
Body-oriented Therapy for Womens Substance Use Disorder Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
September 15, 2017 (Actual)
Study Completion Date
June 30, 2018 (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 long-term objective of this study is to improve women's substance use disorder (SUD) treatment. The immediate project goal is to test the efficacy of an innovative mind-body intervention, Mindful Awareness in Body-Oriented Therapy (MABT) to reduce substance use relapse among women in SUD treatment. A novel mind-body approach, MABT combines a hands-on (manual) approach with mind-body psycho-education approaches of interoceptive training and mindfulness to develop somatically-based self-care skills and to facilitate emotion regulation. A three-group, randomized clinical trial using repeated measures, this project will enroll and randomize 225 women to one of three groups, MABT + Treatment-as-usual (TAU) (n=75), TAU only (n=75), and Women's Health Education (WHE) + TAU (to control for time and attention) (n=75). Study conditions will be compared at baseline, post-intervention, and at 6 and 12 month follow-up. The primary aim is to test the hypothesis that MABT will result in reduced substance use and related health outcomes compared to TAU and to WHE+ TAU at 12 month follow-up. The second aim is to examine hypothesized underlying mechanisms of MABT. Female outpatients in two diverse community treatment facilities, serving racially diverse patients, will be recruited for study participation. This study builds on promising preliminary evidence of MABT feasibility and acceptability in substance use disorder treatment for women, and addresses the need for more clinical research aimed at improving SUD treatment outcomes for women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder
Keywords
Substance Use Disorders, Complementary Therapies, Women, Mind-Body Therapies, Behavior and Behavior Mechanisms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual (TAU)
Arm Type
No Intervention
Arm Description
Usual intensive outpatient treatment for substance use disorders
Arm Title
Mindful Awareness in Body-oriented Therapy (MABT)
Arm Type
Experimental
Arm Description
A mind-body intervention to teach interoceptive skills for self-care.
Arm Title
Womens Health Education
Arm Type
Active Comparator
Arm Description
A comparative arm to control for time and attention that involves education about the human body relevant to women's health.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Awareness in Body-oriented Therapy
Intervention Type
Behavioral
Intervention Name(s)
Womens Health Education
Primary Outcome Measure Information:
Title
Timeline Follow-back Interview (TLFB)
Description
Collects self-report substance use information using a calendar method
Time Frame
Change from baseline in TLFB assessed at different time points (3,6 and 12 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) female, 2) enrolled in intensive outpatient (IOP) with at least 8 weeks remaining in planned SUD treatment program, 3) agrees to forgo (non-study) manual therapies (e.g.,massage) and mind-body therapies (e.g., mindfulness meditation) for 3 months (baseline to post-test); 4) willing to sign release for access of electronic medical records; 5) fluent in English; and 6) can attend MABT and WHE sessions when offered. Exclusion Criteria: ) untreated psychotic diagnosis or symptoms, using modules from the MINI International Neuropsychiatric Interview; 2) unwilling or unable to remain in treatment for the duration of the trial (includes planned relocation, pending incarceration, planned surgical procedures, etc.); 3) cognitive impairment, to be assessed with an informed consent quiz, followed by the Mini-Mental Status Exam (MMSE), a common screening tool in SUD treatment studies, if there is demonstrated difficulty comprehending the consent; or 4) currently pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia J Price, PhD, MA
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22119181
Citation
Price CJ, Wells EA, Donovan DM, Rue T. Mindful awareness in body-oriented therapy as an adjunct to women's substance use disorder treatment: a pilot feasibility study. J Subst Abuse Treat. 2012 Jul;43(1):94-107. doi: 10.1016/j.jsat.2011.09.016. Epub 2011 Nov 25.
Results Reference
background
PubMed Identifier
22524991
Citation
Price CJ, Wells EA, Donovan DM, Brooks M. Implementation and acceptability of Mindful Awareness in Body-oriented Therapy in women's substance use disorder treatment. J Altern Complement Med. 2012 May;18(5):454-62. doi: 10.1089/acm.2011.0126. Epub 2012 Apr 23.
Results Reference
background
PubMed Identifier
26567088
Citation
Price CJ, Crowell SE. Respiratory sinus arrhythmia as a potential measure in substance use treatment--outcome studies. Addiction. 2016 Apr;111(4):615-25. doi: 10.1111/add.13232. Epub 2016 Jan 5.
Results Reference
background

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Body-oriented Therapy for Women in SUD Treatment

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