- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02918565
Mechanisms for Alcohol Treatment Change [MATCH] Study (MATCH)
November 16, 2023 updated by: Maria Pacella, University of Pittsburgh
A 5-arm randomized trial to determine what components of a text message intervention are necessary to reduce hazardous drinking among young adults and mechanisms through which these changes occur.
Study Overview
Status
Completed
Conditions
Detailed Description
Young adults ages 18-25 have high rates of hazardous alcohol use and alcohol-related consequences.
The Emergency Department (ED) provides an important opportunity to identify young adult hazardous drinkers who could benefit from interventions.
A Text Message (TM) intervention was shown to reduce alcohol consumption among young adult ED patients, showing durable effects over 9-months.
The TM intervention uses behavior change techniques with the largest effect sizes in an alcohol intervention meta-analysis: "goal commitment" and "self-monitoring", along with real-time "feedback".
However, the unique effect of these ingredients, and mechanisms (processes occurring within the individual) through which they operate to reduce drinking remain unclear, a critical gap addressed by this project.
Young adult ED patients (ages 18-25) who screen positive for hazardous drinking will be recruited to participate in a randomized trial to determine how best to help individuals reduce hazardous drinking.
All participants will be asked to complete web-based surveys at baseline, 12 and 24 weeks after enrollment, complete brief psychomotor tasks weekly for 14 weeks, and respond to text messages each Thursday and Sunday for the next 12 weeks.
Those randomized to the TM interventions will additionally receive feedback on their text reports.
The four TM intervention arms are: (1) Drinking Cognition Feedback (DCF), (2) Alcohol Risk Feedback (ARF), (3) Adaptive Goal Support (AGS) and (4) a combination of DCF, ARF, and AGS=COMBO).
Study results have implications for designing efficient mobile interventions, and developing a dynamic theory of behavior change.
Study Type
Interventional
Enrollment (Actual)
1131
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15261
- University of Pittsburgh Medical Center Emergency Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- total score of >2 for women or >3 for men on the AUDIT-C
- at least 1 binged drinking episode in the prior 30 days
Exclusion Criteria:
- no cell phone with text messaging
- have been diagnosed with an alcohol or substance use disorder
- pregnant or planning pregnancy
- taking medicine for a psychiatric disorder (including depression, anxiety)
- taking any medicine that could interact with alcohol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drinking Cognition Feedback (DCF)
12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk).
|
12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk).
|
Experimental: Alcohol Risk Feedback (ARF)
12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend).
|
12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend).
|
Experimental: Adaptive Goal Support (AGS)
10 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed).
|
12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed).
|
Experimental: COMBO
12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS.
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12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS.
|
No Intervention: Control
12 weeks of text message assessments without any feedback
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Binge Drinking Days
Time Frame: 12 weeks after starting intervention
|
Measured by the # days on the Timeline Followback Calendar that a male reported 5+ drinks or a female reported 4+ drinks
|
12 weeks after starting intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drinks Per Drinking Day
Time Frame: 12 weeks after starting intervention
|
drinks per drinking day = mean drinks divided by the number of days with any alcohol consumption using the 30-day TLFB Calendar.
|
12 weeks after starting intervention
|
Count of Participants With Any Binge Drinking Day
Time Frame: 12 weeks after starting intervention
|
Using the Timeline Followback Calendar, any male participant reported one or more days with 5+ drinks or a female with one or more days with 4+ drinks are coded=1; otherwise participant is coded=0
|
12 weeks after starting intervention
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Brief Young Adult Alcohol Consequences Questionnaire Score
Time Frame: 12 weeks after starting intervention
|
Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ).
The B-YAACQ is a 24-item measure of alcohol- related problems that utilizes a dichotomous (present or absent) scoring format.
Sum of items 1-48.
Higher scores (count of items marked as 'present') on the B-YAACQ not only indicate a wider variety but also reflect a more severe pattern of alcohol-related problems.
|
12 weeks after starting intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian Suffoletto, MD MS, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
November 22, 2021
Study Completion (Actual)
November 22, 2021
Study Registration Dates
First Submitted
September 23, 2016
First Submitted That Met QC Criteria
September 27, 2016
First Posted (Estimated)
September 29, 2016
Study Record Updates
Last Update Posted (Actual)
December 5, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY19050262
- R01AA023650 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified dataset provided upon request
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.
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