NCT05756114

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 22, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

February 22, 2023

Last Update Submit

June 9, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, 1 month and 3 months

  • 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.

    Baseline, 1 month and 3 months

Secondary Outcomes (2)

  • Change in Quality of Life

    Baseline, 1 month and 3 months

  • Change in recovery capital

    Baseline, 1 month and 3 months

Study Arms (2)

Psychoeducation Condition

ACTIVE COMPARATOR

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

Other: Psychoeducational Email

Support Group Condition

EXPERIMENTAL

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

Behavioral: Support Group

Interventions

Support GroupBEHAVIORAL

Support Group condition, meetings will be held online via HIPAA-compliant Zoom and run by a trained SMART Recovery meeting facilitator

Support Group Condition

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

Psychoeducation Condition

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcoholism

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Marc Potenza, PhD, MD

    Yale University: Professor of Psychiatry, in the Child Study Center and of Neuroscience

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 6, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

June 12, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share