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Exercise as Alcohol Use Disorders Intervention for Non-Treatment Seeking Adults

Primary Purpose

Alcohol-Related Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Motivational Enhancement Therapy plus Contingency Management
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol-Related Disorders

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 21-55 years
  • English speaking
  • Sedentary
  • Alcohol-related problems
  • Recent heavy drinking episodes
  • Blood pressure <165/95 mmHg

Exclusion Criteria:

  • Currently receiving or desiring treatment for alcohol problems
  • Contraindications for exercise
  • Acute psychiatric problems that require immediate treatment
  • Obese - class II
  • Pregnant or desire to become so in the next several months
  • Other substance dependence
  • In recovery for pathological gambling

Sites / Locations

  • Saint Louis University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Assessment Only

Weekly Exercise Counseling Intervention

Arm Description

Outcomes

Primary Outcome Measures

Monthly drinking frequency

Secondary Outcome Measures

Monthly Exercise Behavior

Full Information

First Posted
July 19, 2011
Last Updated
April 4, 2014
Sponsor
St. Louis University
Collaborators
University of Connecticut, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01399554
Brief Title
Exercise as Alcohol Use Disorders Intervention for Non-Treatment Seeking Adults
Official Title
Exercise as Alcohol Use Disorders Intervention for Non-Treatment Seeking Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
Collaborators
University of Connecticut, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Alcohol use disorders are common and few individuals with the disorder ever seek help. This study proposes to intervene in a novel way - exercise, as it has many mental and physical health benefits and is an activity that is incompatible with simultaneous alcohol use. If effective, this non-stigmatizing intervention may increase the utility and acceptability of interventions for alcohol use disorders and ultimately increase the number of individuals effectively treated.
Detailed Description
About 26 million Americans (8.5%) meet criteria for an alcohol use disorder (AUD; i.e., abuse or dependence), and most with an AUD will not ever seek help. A variety of reasons exist for not seeking help, with stigma and desire to handle the problem on one's own being primary among them. Therefore, offering interventions for AUD that do not stigmatize or require an individual to see a mental health professional may increase the utility and acceptability of AUD interventions and ultimately increase the number of individuals effectively treated. This pilot study evaluates exercise as an AUD intervention. Exercise has been proposed as a potential treatment for AUD due to its numerous mental and physical health benefits. Thirty sedentary non-treatment seeking AUD individuals to be recruited from the community via advertisements. Participants will be given a four month YMCA gym membership and will be randomized to one of two conditions: (1) assessment only (AO), or (2) a combination of two motivational enhancement therapy (MET) sessions focused on increasing exercise spaced two months apart and four months of weekly contingency management (CM) for adhering to specific exercise activities. MET is a client-centered, directive method of enhancing intrinsic motivation to change by exploring and resolving ambivalence, and CM is a behavioral treatment offering individuals tangible reinforcers such as prizes for completion of specific target behaviors. Assessments of all participants will take place at baseline, 2-months (mid-treatment), and 4-months (post-treatment. Results from this pilot study will guide future investigations of exercise as a method for intervening with non-treatment seeking AUD individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assessment Only
Arm Type
No Intervention
Arm Title
Weekly Exercise Counseling Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy plus Contingency Management
Other Intervention Name(s)
MET, CM
Intervention Description
A combination of two motivational enhancement therapy (MET) sessions focused on increasing exercise spaced two months apart and four months of weekly contingency management (CM) for adhering to specific exercise activities. MET is a client-centered, directive method of enhancing intrinsic motivation to change by exploring and resolving ambivalence, and CM is a behavioral treatment offering individuals tangible reinforcers such as prizes for completion of specific target behaviors.
Primary Outcome Measure Information:
Title
Monthly drinking frequency
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Monthly Exercise Behavior
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 21-55 years English speaking Sedentary Alcohol-related problems Recent heavy drinking episodes Blood pressure <165/95 mmHg Exclusion Criteria: Currently receiving or desiring treatment for alcohol problems Contraindications for exercise Acute psychiatric problems that require immediate treatment Obese - class II Pregnant or desire to become so in the next several months Other substance dependence In recovery for pathological gambling
Facility Information:
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31424244
Citation
Weinstock J, Petry NM, Pescatello LS, Henderson CE, Nelson CR. Randomized clinical trial of exercise for nontreatment seeking adults with alcohol use disorder. Psychol Addict Behav. 2020 Feb;34(1):65-75. doi: 10.1037/adb0000506. Epub 2019 Aug 19.
Results Reference
derived

Learn more about this trial

Exercise as Alcohol Use Disorders Intervention for Non-Treatment Seeking Adults

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