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NCT01280916 · ClinicalTrials.gov registry record · Phase 1
Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment
A Phase 1 study of Substance Use Disorder, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT01280916: Completed Phase 1 study of Substance Use Disorder, sponsored by University of Washington.
NCT01280916 is a Phase 1 study of Substance Use Disorder that has completed, run by University of Washington. The registered enrollment target is 46 participants, below the 819-participant average among 18 other Substance Use Disorder trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01280916, a Phase 1 study of Substance Use Disorder, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- BEHAVIORAL Mindful Awareness in Body-oriented Therapy
Study Locations (1)
Washington
- Residence XII - Kirkland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
What the finished NCT01280916 record still lists
NCT01280916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 819-participant average among 18 other Substance Use Disorder trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Substance Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Mindful Awareness in Body-oriented Therapy is the first listed.
NCT01280916 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT01280916 about?
NCT01280916 is a clinical study titled "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 embodim...
What is the current status of trial NCT01280916?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2008-10. Estimated completion is 2011-03.
What conditions does trial NCT01280916 study?
This clinical trial studies the following conditions: Substance Use Disorder.
What interventions are being tested in trial NCT01280916?
The interventions under investigation include: Mindful Awareness in Body-oriented Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01280916?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01280916 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 NCT01280916's enrollment target sits among peer trials
46 16th of 18 higher than 3 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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