- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03337438
Alcohol and Health: Personalized Feedback
October 29, 2019 updated by: Emma Brett, Oklahoma State University
Heavy episodic drinking (HED) among college students remains a concern within the U.S., as rates of HED are still high in this population.
Though a variety of brief motivational interventions for alcohol use in college students have demonstrated significant effects, these effects are often small and not consistently maintained over time.
Personalized feedback interventions (PFIs) are a particularly promising approach, as these are often acceptable to college students, as well as low-cost, and easy to disseminate.
Though presentation of interperson discrepancy via descriptive and injunctive norms has shown consistent effects within PFIs and received much attention in the literature, intraperson, or ideal-actual self discrepancies, has largely been ignored.
Drawing from cognitive dissonance theory, self-regulation theory, and motivational interviewing, the current study aims to evaluate the efficacy of an alcohol PFI with a values component to incorporate ideal-self discrepancy into a typical intervention.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
320
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
-
-
Oklahoma
-
Stillwater, Oklahoma, United States, 74078
- North Murray Hall Oklahoma State University
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be at least 18 years of age
- Must be able to speak and read English
- Must report consuming alcohol in a typical week over the past month
Exclusion Criteria:
- Must not deny drinking within the past month
- Non-English speaking
- Under the age of 18
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Values-PFI
|
The PFI with values will include information commonly included in personalized feedback interventions for alcohol use, such as norms information and drinking profile, as well as feedback on three of the assessed values that are highly important to the participant.
|
Other: Traditional-PFI with values assessment
|
This PFI will include information on drinking profile, norms, behavioral strategies used while drinking, and practical costs related to drinking reframed as monetary values and caloric values.
|
Other: Traditional PFI no values assessment
|
This PFI will include information on drinking profile, norms, behavioral strategies used while drinking, and practical costs related to drinking reframed as monetary values and caloric values.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol consumption
Time Frame: one-month post baseline
|
measured by drinks per week
|
one-month post baseline
|
Alcohol consequences
Time Frame: one month post-baseline
|
measured by the BYAACQ to determine number of consequences experienced in the past month post-baseline
|
one month post-baseline
|
Value-behavior discrepancy for values related to alcohol use
Time Frame: one month post-baseline
|
Measured by the VLQ-A to measure change in behavioral consistency with values specifically related to alcohol use one month post-baseline
|
one month post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceptions of norms
Time Frame: one month post-baseline
|
Perceptions of descriptive norms will be more accurate one month post-baseline
|
one month post-baseline
|
Trait mindfulness
Time Frame: one month post-baseline
|
Levels of mindfulness as measured by the FFMQ will be measured at both time points
|
one month post-baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 22, 2017
Primary Completion (Actual)
October 29, 2019
Study Completion (Actual)
October 29, 2019
Study Registration Dates
First Submitted
October 27, 2017
First Submitted That Met QC Criteria
November 6, 2017
First Posted (Actual)
November 9, 2017
Study Record Updates
Last Update Posted (Actual)
October 30, 2019
Last Update Submitted That Met QC Criteria
October 29, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AS1770
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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