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Completed

NCT Number: NCT01438346

Behavioral Treatment for Substance Abuse

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.

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Key information

Conditions

Substance-related Disorders Chemically-Induced Disorders Mental Disorders

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

House of Hope, Salt Lake City, Utah, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Substance Abuse Education

Behavioral

10 weeks of usual care for substance abuse.

Other names: Substance abuse usual care, Substance abuse treatment as usual

Mind-body Bridging

Behavioral

Two sessions per week for 10 weeks, besides usual care treatment for substance abuse.

Other names: Mind and Body Bridging Program

Primary outcomes

  1. 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

  2. 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

  1. Subjective distress

    Time frame: 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.

  2. Depression

    Time frame: 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.

  3. Sleep

    Time frame: 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.

  4. Mindfulness

    Time frame: 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.

  5. Self-Compassion

    Time frame: 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).

  6. Well-being

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 22, 2011
Registry last updated
Dec 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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