Behavioral Treatment for Substance Abuse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoshio Nakamura, University of Utah
ClinicalTrials.gov Identifier:
NCT01438346
First received: September 16, 2011
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Substance-Related Disorders
Behavioral: Substance Abuse Education
Behavioral: Mind-body Bridging
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Two Group-based Intervention Programs for Patients With Substance Abuse Problems

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Change from baseline in the measure of the Penn Alcohol and Craving Scale [ Time Frame: Week 5 and Week 11 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Subjective distress [ Time Frame: Pre (Baseline) Mid (Week 5), Post (Week 11) ] [ Designated as safety issue: No ]
    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.

  • Depression [ Time Frame: Pre (Baseline) Mid (Week 5), Post (Week 11) ] [ Designated as safety issue: No ]
    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.

  • Sleep [ Time Frame: Pre (Baseline) Mid (Week 5), Post (Week 11) ] [ Designated as safety issue: No ]
    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.

  • Mindfulness [ Time Frame: Pre (Baseline) Mid (Week 5), Post (Week 11) ] [ Designated as safety issue: No ]
    The Five-facet Mindfulness Questionnaire (FFMQ) comprises five clear, interpretable facets of mindfulness: acting with awareness, observing, describing, non-judging, non-reacting.

  • Self-Compassion [ Time Frame: Pre (Baseline) Mid (Week 5), Post (Week 11) ] [ Designated as safety issue: No ]
    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).

  • Well-being [ Time Frame: Weekly for 11 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 38
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Mind and Body Bridging Program

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01438346

Locations
United States, Utah
House of Hope
Salt Lake City, Utah, United States, 84102
Pain Research Center, Anesthesiology, University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Yoshi Nakamura, Ph.D. University of Utah
  More Information

No publications provided

Responsible Party: Yoshio Nakamura, Research Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01438346     History of Changes
Other Study ID Numbers: IRB00027696
Study First Received: September 16, 2011
Last Updated: April 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Substance Abuse
Substance Addiction
Substance Dependence
Treatment program

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014