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Completed

NCT Number: NCT01280916

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 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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Residence XII

Kirkland, Washington, 98034, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Current domestic violence
  • Pregnant

Treatment and study plan

Mindful Awareness in Body-oriented Therapy

Behavioral

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

Primary outcomes

  1. Percent Days Substance Use

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jan 21, 2011
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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