- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05767567
Evaluating the Efficacy of a Brief Online Intervention Among Current Heavy Drinkers
Unhealthy alcohol consumption is common in the UK and causes tremendous harm to the individual, as well as harm to others. A significant gap in providing alcohol support is that most people with unhealthy alcohol consumption will never receive advice to cut down on their drinking. However, many are interested in self-directed interventions to help them evaluate their drinking and to motivate reductions in alcohol use. One such promising intervention uses online personalised normative feedback (PNF) which compares a person's drinking with others in the general population of the same age and sex. PNF interventions are thought to work because many people with unhealthy alcohol consumption overestimate how much others drink. Multiple trials have demonstrated that providing PNF to people with unhealthy consumption reduces their alcohol use . While several UK websites do provide feedback on assessment of risk (e.g., Down Your Drink introductory section, Alcohol Change UK), there appears to be no online intervention that provides PNF for unhealthy alcohol consumption.
The major objective of this pilot project is to conduct a two-arm, parallel group randomised controlled trial (RCT) in which 1,318 participants recruited from the Prolific website who have identified themselves as drinking 14 or more units per week are randomly assigned to one of two groups - a) those who are offered a PNF report, and b) those in a no intervention comparator group. Participants in the comparator group will not be provided any intervention materials but will instead be given a list of the different components of the PNF feedback and will be asked to think about how useful they would find each of them. Follow-up assessment will occur at 1 and 6 months post-randomisation. The project is described as a pilot because it is a preliminary evaluation of the PNF intervention in a UK context.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: John A Cunningham, PhD
- Phone Number: 020 7836 5454
- Email: john.cunningham@kcl.ac.uk
Study Locations
-
-
-
London, United Kingdom, WC2R 2LS
- King's College London
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1) score 8 or more on the AUDIT (indicating current unhealthy alcohol use); and 2) endorsed the attention check questions correctly.
Exclusion Criteria:
Not meeting these inclusion criteria forms the exclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Brief Check Your Drinking (CYD)
The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking
|
The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of drinks consumed during a typical week
Time Frame: Three months
|
Three months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR-22/23-34937
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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