Trial record 5 of 306 for:    (substance abuse OR addiction) AND (woman OR women OR female OR maternal OR pregnan)

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01280916
First received: January 12, 2011
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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.

Condition Intervention Phase
Substance Use Disorder
Behavioral: Mindful Awareness in Body-oriented Therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Percent Days Substance Use [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: October 2008
Study Completion Date: March 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mind-body intervention
Mindful Awareness in Body-oriented Therapy
Behavioral: Mindful Awareness in Body-oriented Therapy
8 weekly sessions of 1.5 hours each delivered to women in substance use disorder treatment
No Intervention: Treatment as Usual

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280916

Locations
United States, Washington
Residence XII
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Cynthia J Price, PhD University of Washington
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01280916     History of Changes
Other Study ID Numbers: 33795-C, R21DA024771
Study First Received: January 12, 2011
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014