NCT01828307

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

April 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

5.9 years

First QC Date

April 3, 2013

Last Update Submit

April 2, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    At baseline and every three months for one year.

  • 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.

    At baseline and every three months for one year.

Secondary Outcomes (1)

  • Change in stress reactivity over time.

    At baseline and two additional times over one year.

Study Arms (2)

Standard Aftercare Treatment

ACTIVE COMPARATOR

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

Standard Aftercare Treatment + Exercise Intervention

EXPERIMENTAL

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)Behavioral: Contingency managementBehavioral: Standard Aftercare Treatment

Interventions

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.

Standard Aftercare Treatment + Exercise Intervention

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 + Exercise Intervention

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 TreatmentStandard Aftercare Treatment + Exercise Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA St. Louis Health Care System - Jefferson Barracks Division

St Louis, Missouri, 63125-4101, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jeremiah Weinstock, PhD

    St. Louis University

    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
Associate Professor

Study Record Dates

First Submitted

April 3, 2013

First Posted

April 10, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

April 4, 2019

Record last verified: 2019-04

Locations