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NCT01960036 · ClinicalTrials.gov registry record · NA
Body-oriented Therapy for Women in SUD Treatment
A NA study of Substance Use Disorder, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 217
- Enrollment target
- 1
- Study location
NCT01960036: Completed NA study of Substance Use Disorder, sponsored by University of Washington.
NCT01960036 is a NA study of Substance Use Disorder that has completed, run by University of Washington. The registered enrollment target is 217 participants, below the 810-participant average among 18 other Substance Use Disorder trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01960036, a NA study of Substance Use Disorder, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 217 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Collects self-report substance use information using a calendar method
Conditions Studied
Interventions
- BEHAVIORAL Mindful Awareness in Body-oriented Therapy
- BEHAVIORAL Womens Health Education
Study Locations (1)
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2014-01 |
| Est. Completion | 2018-06-30 |
| Phase | NA |
What the finished NCT01960036 record still lists
NCT01960036 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, below the 810-participant average among 18 other Substance Use Disorder trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Substance Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Mindful Awareness in Body-oriented Therapy is the first listed.
NCT01960036 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT01960036 about?
NCT01960036 is a clinical study titled "Body-oriented Therapy for Women in SUD Treatment". 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 treatme...
What is the current status of trial NCT01960036?
This trial is currently completed. It is a NA study. The enrollment target is 217 participants. The study started on 2014-01. Estimated completion is 2018-06-30.
What conditions does trial NCT01960036 study?
This clinical trial studies the following conditions: Substance Use Disorder.
What interventions are being tested in trial NCT01960036?
The interventions under investigation include: Mindful Awareness in Body-oriented Therapy (BEHAVIORAL), Womens Health Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT01960036?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01960036 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01960036's enrollment target sits among peer trials
217 6th of 18 higher than 13 of 18 other Substance Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Substance Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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