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Exercise: Addressing Stress in Relapse Prevention for Substance Use Disorders

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational enhancement therapy (MET)
Contingency management
Standard Aftercare Treatment
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA St. Louis Health Care System - Jefferson Barracks Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Aftercare Treatment

Standard Aftercare Treatment + Exercise Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in substance use (relapse)
Relapse is assessed during the duration of the study and is a time to event variable so it will be assess over time. Relapse is defined as drinking alcohol in excess of the National Institute on Alcohol Abuse and Alcohol (NIAAA) at-risk guidelines.
Change in moderate to vigorous physical activity
Moderate to vigorous physical activity frequency, duration and intensity will be assessed over time to examine changes in response to the intervention. Frequency is defined as how often and individual engages in moderate to vigorous physical activity. Duration is the amount of time (minutes) per episode that individual engages in moderate to vigorous physical activity. Intensity is defined two ways: (1) self-report rating of intensity and (2) metabolic equivalent of the moderate to vigorous physical activity.

Secondary Outcome Measures

Change in stress reactivity over time.
Stress reactivity is assess via a standardized psychosocial stressor paradigm that induces stress. Stress is assessed via salivary cortisol and self-report of stress.

Full Information

First Posted
April 3, 2013
Last Updated
April 2, 2019
Sponsor
St. Louis University
Collaborators
VA St. Louis Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01828307
Brief Title
Exercise: Addressing Stress in Relapse Prevention for Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
Collaborators
VA St. Louis Health Care System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Aftercare Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Aftercare Treatment + Exercise Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational enhancement therapy (MET)
Intervention Description
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
Intervention Name(s)
Contingency management
Intervention Description
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
Intervention Name(s)
Standard Aftercare Treatment
Intervention Description
Aftercare includes the following topics: substance use, high-risk situations, coping and life skills training, focus groups for depression and anxiety, and AIDS education.
Primary Outcome Measure Information:
Title
Change in substance use (relapse)
Description
Relapse is assessed during the duration of the study and is a time to event variable so it will be assess over time. Relapse is defined as drinking alcohol in excess of the National Institute on Alcohol Abuse and Alcohol (NIAAA) at-risk guidelines.
Time Frame
At baseline and every three months for one year.
Title
Change in moderate to vigorous physical activity
Description
Moderate to vigorous physical activity frequency, duration and intensity will be assessed over time to examine changes in response to the intervention. Frequency is defined as how often and individual engages in moderate to vigorous physical activity. Duration is the amount of time (minutes) per episode that individual engages in moderate to vigorous physical activity. Intensity is defined two ways: (1) self-report rating of intensity and (2) metabolic equivalent of the moderate to vigorous physical activity.
Time Frame
At baseline and every three months for one year.
Secondary Outcome Measure Information:
Title
Change in stress reactivity over time.
Description
Stress reactivity is assess via a standardized psychosocial stressor paradigm that induces stress. Stress is assessed via salivary cortisol and self-report of stress.
Time Frame
At baseline and two additional times over one year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremiah Weinstock, PhD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA St. Louis Health Care System - Jefferson Barracks Division
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63125-4101
Country
United States

12. IPD Sharing Statement

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Exercise: Addressing Stress in Relapse Prevention for Substance Use Disorders

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