Clinical trial NCT01280916: Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment
Official title: Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Substance Use Disorder
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-01-21
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent Days Substance Use
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kirkland
country: United States
facility: Residence XII
state: Washington
Study officials:
affiliation: University of Washington
name: Cynthia J Price, PhD
role: PRINCIPAL_INVESTIGATOR
References: