Evaluating the Efficacy of a Brief Online Intervention Among Current Heavy Drinkers
Primary Purpose
Alcohol Consumption
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Brief Check Your Drinking (CYD)
Sponsored by
About this trial
This is an interventional other trial for Alcohol Consumption
Eligibility Criteria
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
Sites / Locations
- King's College London
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Brief Check Your Drinking (CYD)
Control
Arm Description
The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking
Outcomes
Primary Outcome Measures
Number of drinks consumed during a typical week
Secondary Outcome Measures
Full Information
NCT ID
NCT05767567
First Posted
March 2, 2023
Last Updated
September 11, 2023
Sponsor
King's College London
1. Study Identification
Unique Protocol Identification Number
NCT05767567
Brief Title
Evaluating the Efficacy of a Brief Online Intervention Among Current Heavy Drinkers
Official Title
Evaluating the Efficacy of a Brief Online Intervention Among Current Heavy Drinkers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
July 3, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
867 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief Check Your Drinking (CYD)
Arm Type
Experimental
Arm Description
The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Brief Check Your Drinking (CYD)
Intervention Description
The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking
Primary Outcome Measure Information:
Title
Number of drinks consumed during a typical week
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
WC2R 2LS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Available from the PI upon reasonable request.
Learn more about this trial
Evaluating the Efficacy of a Brief Online Intervention Among Current Heavy Drinkers
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