Alcohol Use DisorderSMARTNCT05756114
Self Management and Recovery Training (SMART) Recovery Study
A study testing Support Group and Psychoeducational Email in people with Alcohol Use Disorder, run by Yale University.
Trial summary
This study identifies whether and how online support groups may work to confer therapeutic benefits onto its participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Support Group and Psychoeducational Email
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Self Management and Recovery Training (SMART) Recovery Involvement and Alcohol Use Outcomes
This study identifies whether and how online support groups may work to confer therapeutic benefits onto its participants.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Support Group, Psychoeducational Email
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support GroupBehavioural
Support Group condition, meetings will be held online via HIPAA-compliant Zoom and run by a trained SMART Recovery meeting facilitator
Psychoeducational EmailOther
Participants receive a weekly email with a Qualtrics survey link containing psychoeducational content.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation Condition | Active comparator | Participants receive a weekly email with a Qualtrics survey link containing psychoeducational content. Receives: Other: Psychoeducational Email |
| Support Group Condition | Experimental | Participants will attend six weekly online SMART Recovery meetings in groups of five to eight. Receives: Behavioral: Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 1 month and 3 months
Secondary outcomes (2)
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. .
Measured: Baseline, 1 month and 3 months
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.
Measured: Baseline, 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study startApr 2023 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Why it stopped: The focus of the project has shifted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Addiction Psychology
- Responsible party
- Sponsor
- Investigators
- Marc Potenza, PhD, MD, Principal investigator, Yale University: Professor of Psychiatry, in the Child Study Center and of Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756114
- Sponsor's protocol ID
- 2000034747
- Acronym
- SMART
- Status last verified
- Jun 2023
- First submitted
- 22 Feb 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Management and Recovery Training (SMART) Recovery Involvement and Alcohol Use Outcomes
- ClinicalTrials.gov ID
- NCT05756114
- Acronym / sponsor ID
- SMART / 2000034747
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The focus of the project has shifted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Society of Addiction Psychology
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation Condition | Active comparator | Other: Psychoeducational EmailParticipants receive a weekly email with a Qualtrics survey link containing psychoeducational content. |
| Support Group Condition | Experimental | Behavioral: Support GroupParticipants will attend six weekly online SMART Recovery meetings in groups of five to eight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Support GroupSupport Group condition, meetings will be held online via HIPAA-compliant Zoom and run by a trained SMART Recovery meeting facilitator | Behavioural | Support Group Condition |
| Psychoeducational EmailParticipants receive a weekly email with a Qualtrics survey link containing psychoeducational content. | Other | Psychoeducation Condition |
Primary outcome
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.
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.
2 secondary outcomes
Change in Quality of Life
Time frame: Baseline, 1 month and 3 months
Change in recovery capital
Time frame: Baseline, 1 month and 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Potenza, PhD, MD principal investigator
Yale University: Professor of Psychiatry, in the Child Study Center and of Neuroscience
Questions about this trial
What is this clinical trial studying?
A study testing Support Group and Psychoeducational Email in people with Alcohol Use Disorder, run by Yale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in past-month alcohol use: drinking days (time frame: Baseline, 1 month and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.