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Self Management and Recovery Training (SMART) Recovery Study (SMART)

Primary Purpose

Alcohol Use Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Support Group
Psychoeducational Email
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

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

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Psychoeducation Condition

    Support Group Condition

    Arm Description

    Participants receive a weekly email with a Qualtrics survey link containing psychoeducational content.

    Participants will attend six weekly online SMART Recovery meetings in groups of five to eight.

    Outcomes

    Primary Outcome Measures

    Change in past-month alcohol use: drinking days
    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.
    Change in past-month alcohol drug use: heavy drinking days
    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.

    Secondary Outcome Measures

    Change in Quality of Life
    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. .
    Change in recovery capital
    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.

    Full Information

    First Posted
    February 22, 2023
    Last Updated
    June 9, 2023
    Sponsor
    Yale University
    Collaborators
    Society of Addiction Psychology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05756114
    Brief Title
    Self Management and Recovery Training (SMART) Recovery Study
    Acronym
    SMART
    Official Title
    Self Management and Recovery Training (SMART) Recovery Involvement and Alcohol Use Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The focus of the project has shifted.
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    April 2025 (Anticipated)
    Study Completion Date
    April 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    Society of Addiction Psychology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study identifies whether and how online support groups may work to confer therapeutic benefits onto its participants.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Psychoeducation Condition
    Arm Type
    Active Comparator
    Arm Description
    Participants receive a weekly email with a Qualtrics survey link containing psychoeducational content.
    Arm Title
    Support Group Condition
    Arm Type
    Experimental
    Arm Description
    Participants will attend six weekly online SMART Recovery meetings in groups of five to eight.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Support Group
    Intervention Description
    Support Group condition, meetings will be held online via HIPAA-compliant Zoom and run by a trained SMART Recovery meeting facilitator
    Intervention Type
    Other
    Intervention Name(s)
    Psychoeducational Email
    Intervention Description
    Participants receive a weekly email with a Qualtrics survey link containing psychoeducational content.
    Primary Outcome Measure Information:
    Title
    Change in past-month alcohol use: drinking days
    Description
    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.
    Time Frame
    Baseline, 1 month and 3 months
    Title
    Change in past-month alcohol drug use: heavy drinking days
    Description
    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.
    Time Frame
    Baseline, 1 month and 3 months
    Secondary Outcome Measure Information:
    Title
    Change in Quality of Life
    Description
    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. .
    Time Frame
    Baseline, 1 month and 3 months
    Title
    Change in recovery capital
    Description
    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.
    Time Frame
    Baseline, 1 month and 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marc Potenza, PhD, MD
    Organizational Affiliation
    Yale University: Professor of Psychiatry, in the Child Study Center and of Neuroscience
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Self Management and Recovery Training (SMART) Recovery Study

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