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Exercise: Addressing Stress in Relapse Prevention for Substance Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01828307
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
VA St. Louis Health Care System
Information provided by (Responsible Party):
Jeremiah Weinstock, St. Louis University

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

Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: Motivational enhancement therapy (MET) Behavioral: Contingency management Behavioral: Standard Aftercare Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2013
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

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Arm Intervention/treatment
Active Comparator: 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.
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.

Experimental: 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.
Behavioral: 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.

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.

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.




Primary Outcome Measures :
  1. Change in substance use (relapse) [ Time Frame: At baseline and every three months for one year. ]
    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.

  2. Change in moderate to vigorous physical activity [ Time Frame: At baseline and every three months for one year. ]
    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 :
  1. Change in stress reactivity over time. [ Time Frame: At baseline and two additional times over one year. ]
    Stress reactivity is assess via a standardized psychosocial stressor paradigm that induces stress. Stress is assessed via salivary cortisol and self-report of stress.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828307


Locations
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United States, Missouri
VA St. Louis Health Care System - Jefferson Barracks Division
Saint Louis, Missouri, United States, 63125-4101
Sponsors and Collaborators
St. Louis University
VA St. Louis Health Care System
Investigators
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Principal Investigator: Jeremiah Weinstock, PhD St. Louis University
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Responsible Party: Jeremiah Weinstock, Associate Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT01828307    
Other Study ID Numbers: R01DA033411-01A1 ( U.S. NIH Grant/Contract )
23298 ( Other Identifier: Saint Louis University Institutional Review Board )
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders