Behavioral Treatment for Substance Abuse
|ClinicalTrials.gov Identifier: NCT01438346|
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : December 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Substance-Related Disorders||Behavioral: Substance Abuse Education Behavioral: Mind-body Bridging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Two Group-based Intervention Programs for Patients With Substance Abuse Problems|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
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.
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
- 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
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438346
|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|
|Principal Investigator:||Yoshi Nakamura, Ph.D.||University of Utah|