Behavioral Treatment for Substance Abuse

Substance-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438346
• Other study ID #: IRB00027696
• Status: Completed
• Phase: N/A
• First received: September 16, 2011
• Last updated: December 1, 2016
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: December 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Behavioral:
• Substance Abuse Education
10 weeks of usual care for substance abuse.
• Mind-body Bridging
Two sessions per week for 10 weeks, besides usual care treatment for substance abuse.

Locations

Country	Name	City	State
United States	House of Hope	Salt Lake City	Utah
United States	Pain Research Center, Anesthesiology, University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No