Behavioral Treatment for Substance Abuse

Not Applicable

Completed

• Conditions: Substance-Related Disorders

• Registration Number: NCT01438346
• Lead Sponsor: University of Utah

Brief Summary

This pilot project will evaluate a new mind-body intervention called Mind-Body Bridging (MBB) for reducing substance abuse problems in women who are undergoing a substance abuse treatment program. The main hypothesis is that MBB will be more effective than the control (standard) intervention program in helping people reduce their craving for illicit substances and/or alcohol.

Detailed Description

This is a randomized clinical pilot study in which MBB will be compared with a standard treatment program for substance abuse. Both groups will run concurrently over the course of a 10-week period, twice per week.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-16
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-22
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• Substance abuse or dependence
• Resident/day client in the House of Hope substance abuse treatment program
• Minimum stay in treatment at House of Hope for 3.5 months
• Fluent in English

Exclusion Criteria

• Psychosis
• Suicide risk
• Dementia
• Significant withdrawal risk
• Severe, unstable depression
• Requires intensive mental health treatment
• Cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in the measure of the Penn Alcohol and Craving Scale	Week 5 and Week 11	Change from baseline in the extent of drug and alcohol craving at Week 5 and Week 11, as measured by a modified version of the Penn Alcohol and Craving Scale
Change from baseline in Alcohol and Drug Use Consequences Scale	Week 5 and Week 11	Change from baseline in the measure of alcohol and drug consequences at Week 5 and Week 11, as measured by Alcohol and Drug Use Consequences Scale

Secondary Outcome Measures

Name	Time	Method
Sleep	Pre (Baseline) Mid (Week 5), Post (Week 11)	The Medical Outcomes Study Sleep Scale (MOS-SS) provides an index of sleep problems and incorporates six sleep scale scores: 1) sleep disturbance, 2) sleep adequacy, 3) daytime somnolence, 4) snoring, 5) waking up short of breath with a headache, and 6) quantity of sleep. The MOS-SS is similar to the Pittsburgh Sleep Quality Index (PSQI) developed at the same time, which includes more questions about sleep disturbance with seven more items overall. The 1-week assessment is adapted from the normal 4-week retrospective assessment.
Well-being	Weekly for 11 weeks	The Well-Being Index (WBI)is a 5-item scale developed and validated by the World Health Organization Collaborating Centre in Mental Health. The WBI will be used to assess whether participants show any changes in general well-being.
Self-Compassion	Pre (Baseline) Mid (Week 5), Post (Week 11)	Self compassion is measured by the Self-Compassion Scale that comprises 26 items. Self-compassion is an emotionally positive self-attitude that should protect against the negative consequences of self-judgment, isolation, and rumination (such as depression).
Depression	Pre (Baseline) Mid (Week 5), Post (Week 11)	The Center for Epidemiologic Studies Depression Scale is one of the most common screening tests to determine an individual's depression quotient. The test measures depressive feelings and behaviors during the past week.
Mindfulness	Pre (Baseline) Mid (Week 5), Post (Week 11)	The Five-facet Mindfulness Questionnaire (FFMQ) comprises five clear, interpretable facets of mindfulness: acting with awareness, observing, describing, non-judging, non-reacting.
Subjective distress	Pre (Baseline) Mid (Week 5), Post (Week 11)	Impact of Events Scale - Revised (IES-R) is a 22-item self-report measure that assesses subjective distress caused by traumatic events. The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.

Trial Locations

Locations (2)

House of Hope; 🇺🇸 Salt Lake City, Utah, United States

Pain Research Center, Anesthesiology, University of Utah; 🇺🇸 Salt Lake City, Utah, United States