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

NCT ID: NCT01280916

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mind-body intervention

Mindful Awareness in Body-oriented Therapy

Group Type: EXPERIMENTAL

Mindful Awareness in Body-oriented Therapy

Intervention Type: BEHAVIORAL

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

Treatment as Usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindful Awareness in Body-oriented Therapy

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Price

Professor: School of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia J Price, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Residence XII

Kirkland, Washington, United States

Countries

United States

Other Identifiers

R21DA024771

Identifier Type: NIH

Identifier Source: secondary_id

View Link

33795

Identifier Type: -

Identifier Source: org_study_id