Behavioral Treatment for Substance Abuse

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Substance Abuse Education

Mind-body Bridging

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring Substance Abuse, Substance Addiction, Substance Dependence, Treatment program

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

House of Hope
Pain Research Center, Anesthesiology, University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Substance Abuse Education (SED)

Mind-body Bridging (MBB)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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.

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.

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.

Mindfulness

The Five-facet Mindfulness Questionnaire (FFMQ) comprises five clear, interpretable facets of mindfulness: acting with awareness, observing, describing, non-judging, non-reacting.

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).

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.

Full Information

NCT ID

NCT01438346

First Posted

September 16, 2011

Last Updated

December 1, 2016

Sponsor

University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT01438346

Brief Title

Behavioral Treatment for Substance Abuse

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance-Related Disorders

Keywords

Substance Abuse, Substance Addiction, Substance Dependence, Treatment program

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Substance Abuse Education (SED)

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Mind-body Bridging (MBB)

Arm Type

Experimental

Arm Description

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 Type

Behavioral

Intervention Name(s)

Substance Abuse Education

Other Intervention Name(s)

Substance abuse usual care, Substance abuse treatment as usual

Intervention Description

10 weeks of usual care for substance abuse.

Intervention Type

Behavioral

Intervention Name(s)

Mind-body Bridging

Other Intervention Name(s)

Mind and Body Bridging Program

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in the measure of the Penn Alcohol and Craving Scale

Description

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

Time Frame

Week 5 and Week 11

Title

Change from baseline in Alcohol and Drug Use Consequences Scale

Description

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

Time Frame

Week 5 and Week 11

Secondary Outcome Measure Information:

Title

Subjective distress

Description

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.

Time Frame