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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05767567
Other study ID # HR-22/23-34937
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2, 2023
Est. completion date July 31, 2023

Study information

Verified date March 2023
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 867
Est. completion date July 31, 2023
Est. primary completion date July 3, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Brief Check Your Drinking (CYD)
The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking

Locations

Country Name City State
United Kingdom King's College London London

Sponsors (1)

Lead Sponsor Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of drinks consumed during a typical week Three months
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