NCT01438346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 2, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

September 16, 2011

Last Update Submit

December 1, 2016

Conditions

Substance-Related Disorders

Keywords

Substance AbuseSubstance AddictionSubstance DependenceTreatment program

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (6)

  • Subjective distress

    Pre (Baseline) Mid (Week 5), Post (Week 11)

  • Depression

    Pre (Baseline) Mid (Week 5), Post (Week 11)

  • Sleep

    Pre (Baseline) Mid (Week 5), Post (Week 11)

  • Mindfulness

    Pre (Baseline) Mid (Week 5), Post (Week 11)

  • Self-Compassion

    Pre (Baseline) Mid (Week 5), Post (Week 11)

  • +1 more secondary outcomes

Study Arms (2)

Substance Abuse Education (SED)

ACTIVE COMPARATOR

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

Mind-body Bridging (MBB)

EXPERIMENTAL

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

Interventions

Substance Abuse EducationBEHAVIORAL

10 weeks of usual care for substance abuse.

Also known as: Substance abuse usual care, Substance abuse treatment as usual
Substance Abuse Education (SED)
Mind-body BridgingBEHAVIORAL

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

Also known as: Mind and Body Bridging Program
Mind-body Bridging (MBB)

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Psychosis
  • Suicide risk
  • Dementia
  • Significant withdrawal risk
  • Severe, unstable depression
  • Requires intensive mental health treatment
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

House of Hope

Salt Lake City, Utah, 84102, United States

Location

Pain Research Center, Anesthesiology, University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Yoshi Nakamura, Ph.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

September 16, 2011

First Posted

September 22, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 2, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)