A Pilot Study of Two Group-based Intervention Programs for Patients With Substance Abuse Problems
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Change from baseline in the measure of the Penn Alcohol and Craving Scale
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •Significant withdrawal risk
- •Severe, unstable depression
- •Requires intensive mental health treatment
- •Cognitive impairment
Arms & Interventions
Mind-body Bridging (MBB)
Participants in the experimental Mind-Body Bridging (MBB) group, in addition to their usual treatment for substance abuse, will additionally receive instruction on the basics of MBB, and will learn MBB techniques to help deal with their cravings and comorbid psychological conditions. A workbook will be incorporated into the curriculum to provide MBB participants with daily exercises and activities to help facilitate adherence to the MBB program.
Intervention: Mind-body Bridging (Behavioral)
Substance Abuse Education (SED)
The Substance Abuse Education (SED) group will serve as the control intervention in which participants will receive instruction on a variety of topics included in the substance abuse treatment program curriculum. These will include, but are not limited to, information about anger management, smoking cessation, women's issues, and stress management, and approaches to help reduce cravings. Each week the TAU group will meet and a House of Hope (HOH) clinical staff member will discuss the above and related issues and how these may help individuals deal with their substance abuse and related psychological issues.
Intervention: Substance Abuse Education (Behavioral)
Outcomes
Primary Outcomes
Change from baseline in the measure of the Penn Alcohol and Craving Scale
Time Frame: 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
Time Frame: 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 Outcomes
- Depression(Pre (Baseline) Mid (Week 5), Post (Week 11))
- Mindfulness(Pre (Baseline) Mid (Week 5), Post (Week 11))
- Sleep(Pre (Baseline) Mid (Week 5), Post (Week 11))
- Well-being(Weekly for 11 weeks)
- Self-Compassion(Pre (Baseline) Mid (Week 5), Post (Week 11))
- Subjective distress(Pre (Baseline) Mid (Week 5), Post (Week 11))
Investigators
Yoshio Nakamura
Research Assistant Professor
University of Utah