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

NCT01280916 | Completed Phase 1

• 2 other identifiers: 33795R21DA024771
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Use Disorder

Outcome Measures

Primary Outcomes (1)

• Percent Days Substance Use

  9 months

Study Arms (2)

Mind-body intervention

EXPERIMENTAL

Mindful Awareness in Body-oriented Therapy

Behavioral: Mindful Awareness in Body-oriented Therapy

Treatment as Usual

NO INTERVENTION

Interventions

Mindful Awareness in Body-oriented Therapy BEHAVIORAL

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

Mind-body intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current domestic violence
• Pregnant

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Residence XII

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Cynthia J Price, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: School of Nursing

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 21, 2011
• Study Start: October 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: March 1, 2011
• Last Updated: November 19, 2018

Record last verified: 2018-11

Locations

US (1)