Exercise: Addressing Stress in Relapse Prevention for Substance Use Disorders

NCT ID: NCT01828307

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2019-03-31

Brief Summary

Relapse contributes significantly to the chronicity of substance use disorders, one of the most costly medical/mental health problems facing our nation. The incorporation of exercise into relapse prevention efforts will address stress, a critical factor in relapse, provide other health benefits, and improve overall quality of life. Combined, these changes will reduce the risk of relapse to substance use while also lessening the burden of this psychiatric disorder upon society

Detailed Description

About half of all individuals who receive treatment for substance use disorders (SUD) relapse within a year. Stress and an individual's biological response to it are significant predictors of relapse. Thus, interventions that decrease stress and normalize an individual's biological response to stress are desperately needed. Exercise decreases stress and improves the body's regulation of stress. The proposed project will utilize exercise as a novel relapse prevention intervention with individuals who have recently completed inpatient SUD treatment. This project will evaluate the efficacy of a motivational intervention for exercise in a randomized clinical trial of 150 SUD patients beginning Aftercare treatment at the VA St. Louis Health Care System. Participants will be randomized to one of two interventions: (1) standard care (SC), or (2) standard care plus a motivational intervention targeting exercise that lasts for six months. Participants are followed every three months for one year. Results from this study will advance exercise as a new strategy for enhancing stress regulation and prevention of relapse in SUD populations.

Conditions

Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Aftercare Treatment

Standard aftercare treatment consists of once per week group counseling for six months. Aftercare includes the following topics: substance use, high-risk situations, coping and life skills training, focus groups for depression and anxiety, and AIDS education.

Group Type: ACTIVE_COMPARATOR

Standard Aftercare Treatment

Intervention Type: BEHAVIORAL

Aftercare includes the following topics: substance use, high-risk situations, coping and life skills training, focus groups for depression and anxiety, and AIDS education.

Standard Aftercare Treatment + Exercise Intervention

In addition to attending standard aftercare treatment, participants will receive three 50-minute motivational enhancement therapy sessions focused on exercise, plus 24 weekly contingency management sessions for exercise.

Group Type: EXPERIMENTAL

Motivational enhancement therapy (MET)

Intervention Type: BEHAVIORAL

MET is a client-centered, directive method of enhancing intrinsic motivation for change by exploring and resolving ambivalence. In this intervention MET will focus on exercise.

Contingency management

Intervention Type: BEHAVIORAL

Contingency management is a behavioral treatment that utilizes extrinsic motivation by offering individuals tangible rewards such as prizes for completion of specific target behaviors. The target behavior in this study is exercise.

Standard Aftercare Treatment

Intervention Type: BEHAVIORAL

Aftercare includes the following topics: substance use, high-risk situations, coping and life skills training, focus groups for depression and anxiety, and AIDS education.

Interventions

Motivational enhancement therapy (MET)

MET is a client-centered, directive method of enhancing intrinsic motivation for change by exploring and resolving ambivalence. In this intervention MET will focus on exercise.

Intervention Type: BEHAVIORAL

Contingency management

Contingency management is a behavioral treatment that utilizes extrinsic motivation by offering individuals tangible rewards such as prizes for completion of specific target behaviors. The target behavior in this study is exercise.

Intervention Type: BEHAVIORAL

Standard Aftercare Treatment

Aftercare includes the following topics: substance use, high-risk situations, coping and life skills training, focus groups for depression and anxiety, and AIDS education.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Undergoing residential substance use disorders treatment at VA St. Louis Healthcare System
• Age 18 or older
• English speaking;
• Substance dependence
• Recent substance use
• Does not have high blood pressure
• Documented physician clearance to undergo exercise testing & exercise
• Plans to begin Aftercare at the clinic within the next two weeks

Exclusion Criteria

• Severely disruptive behavior
• Serious uncontrolled psychiatric disorder
• Medical history in the past 6 months that contraindicates exercise
• Pregnancy, plans to get pregnant in the next six months.
• Currently breastfeeding
• Obese - class II
• Currently taking corticosteroids or hormonal contraceptives
• In recovery for pathological gambling
• Opiate dependence.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA St. Louis Health Care System

FED

Sponsor Role: collaborator

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Jeremiah Weinstock

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeremiah Weinstock, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

VA St. Louis Health Care System - Jefferson Barracks Division

St Louis, Missouri, United States

Countries

United States

Other Identifiers

23298

Identifier Type: OTHER

Identifier Source: secondary_id

R01DA033411-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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