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CompletedNCT01280916Updated Nov 19, 2018

Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment

A Phase 1 interventional study of Mindful Awareness in Body-oriented Therapy in Substance Use Disorder, sponsored by University of Washington. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-19.

Sponsored by University of Washington · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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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 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.
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Conditions studied

  • Substance Use Disorder
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In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 46 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Current domestic violence
  • Pregnant
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Mind-body intervention

    Mindful Awareness in Body-oriented Therapy

    Behavioral: Mindful Awareness in Body-oriented Therapy

  • No intervention
    Treatment as Usual

Interventions

  • BehavioralMindful Awareness in Body-oriented Therapy

    8 weekly sessions of 1.5 hours each delivered to women in substance use disorder treatment

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What researchers measure

Primary outcomes

  1. Percent Days Substance Use

    Time frame: 9 months

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Study locations

1 site
  • Residence XII
    Kirkland, Washington 98034, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01280916
Lead sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Cynthia Price (Professor: School of Nursing, University of Washington) — Principal investigator
First posted
Jan 21, 2011
Start date
Oct 2008
Primary completion
Aug 2010
Completion
Mar 2011
Last update
Nov 19, 2018

Study contacts

Cynthia J Price, PhD
principal investigator · University of Washington

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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