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Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment
NCT01280916 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01280916
The ClinicalTrials.gov registry entry for NCT01280916 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 987 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01280916 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01280916?
The interventions under investigation include: Mindful Awareness in Body-oriented Therapy (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01280916?
This trial is sponsored by University of Washington, which has 987 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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