- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05756114
Self Management and Recovery Training (SMART) Recovery Study (SMART)
Self Management and Recovery Training (SMART) Recovery Involvement and Alcohol Use Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Online support groups (e.g., SMART Recovery) are an increasingly common non-professional intervention for people who engage in problematic alcohol use, but it is unclear how they help participants reduce their use.
The primary objective of this study is to determine whether alcohol use decreases more after attending online SMART Recovery psychoeducational support group meetings, as compared to receiving psychoeducational content alone.
The secondary objectives are to identify whether variables such as quality of life and recovery capital (i.e., resources to support recovery from addiction) relate to treatment outcomes.
Study Type
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Is fluent in English and have a 6th grade reading level or higher
- AUDIT score of ≥8
- Has some desire to cut down or quit their alcohol use
- Has access to a phone or computer with reliable internet connection, a functional microphone and camera
- Is willing to consent to being audio and video recorded during the meetings
Exclusion Criteria:
- Is not able to commit to the 6 weeks of intervention and the one- and three-month follow-up.
- Has vulnerable population status (e.g., pregnant people, prisoners)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Psychoeducation Condition
Participants receive a weekly email with a Qualtrics survey link containing psychoeducational content.
|
Participants receive a weekly email with a Qualtrics survey link containing psychoeducational content.
|
|
Experimental: Support Group Condition
Participants will attend six weekly online SMART Recovery meetings in groups of five to eight.
|
Support Group condition, meetings will be held online via HIPAA-compliant Zoom and run by a trained SMART Recovery meeting facilitator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in past-month alcohol use: drinking days
Time Frame: Baseline, 1 month and 3 months
|
Timeline Follow-back (TLFB) will be used via survey to characterize changes in alcohol and other drug use for study participants.
Percent Drinking Days will be derived from self-report on TLFB.
|
Baseline, 1 month and 3 months
|
|
Change in past-month alcohol drug use: heavy drinking days
Time Frame: Baseline, 1 month and 3 months
|
Timeline Follow-back (TLFB) will be used via survey to characterize changes in alcohol and other drug use for study participants.
Percent Heavy Drinking Days will be derived from self-report on TLFB.
|
Baseline, 1 month and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of Life
Time Frame: Baseline, 1 month and 3 months
|
Quality of life will be assessed using the WHOQOL-BREF via survey; a 26-item self-report measure of quality of life in four domains.
Scores range from 1-5.
Each domain score is averaged.
Higher scores indicate higher quality of life. .
|
Baseline, 1 month and 3 months
|
|
Change in recovery capital
Time Frame: Baseline, 1 month and 3 months
|
Recovery capital will be assessed using the Assessment of Recovery Capital via survey; A 50-item self-report measure of recovery capital with ten domains; each item is rated in binary, score ranges from 0-50; higher scores indicate higher recovery capital.
|
Baseline, 1 month and 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc Potenza, PhD, MD, Yale University: Professor of Psychiatry, in the Child Study Center and of Neuroscience
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000034747
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.