Behavioral Treatment for Substance Abuse

A Pilot Study of Two Group-based Intervention Programs for Patients With Substance Abuse Problems

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders
• Intervention / Treatment: Behavioral: Substance Abuse Education; Behavioral: Mind-body Bridging

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • House of Hope
    • Salt Lake City, Utah, United States, 84112
      • Pain Research Center, Anesthesiology, University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Substance Abuse Education; 10 weeks of usual care for substance abuse.; Other Names: Substance abuse usual care; Substance abuse treatment as usual
Experimental: 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.	Behavioral: Mind-body Bridging; Two sessions per week for 10 weeks, besides usual care treatment for substance abuse.; Other Names: Mind and Body Bridging Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the measure of the Penn Alcohol and Craving Scale	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	Week 5 and Week 11
Change from baseline in Alcohol and Drug Use Consequences Scale	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	Week 5 and Week 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective distress	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.	Pre (Baseline) Mid (Week 5), Post (Week 11)
Depression	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.	Pre (Baseline) Mid (Week 5), Post (Week 11)
Sleep	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.	Pre (Baseline) Mid (Week 5), Post (Week 11)
Mindfulness	The Five-facet Mindfulness Questionnaire (FFMQ) comprises five clear, interpretable facets of mindfulness: acting with awareness, observing, describing, non-judging, non-reacting.	Pre (Baseline) Mid (Week 5), Post (Week 11)
Self-Compassion	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).	Pre (Baseline) Mid (Week 5), Post (Week 11)
Well-being	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.	Weekly for 11 weeks

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Yoshi Nakamura, Ph.D., University of Utah

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: September 16, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (Estimate): September 22, 2011

Study Record Updates

• Last Update Posted (Estimate): December 2, 2016
• Last Update Submitted That Met QC Criteria: December 1, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Substance Abuse; Substance Dependence; Substance Addiction; Treatment program
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: IRB00027696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO