Evaluating the Efficacy of a Brief Online Intervention Among Current Heavy Drinkers

Sponsor
King's College London (Other)
Overall Status
Recruiting
CT.gov ID
NCT05767567
Collaborator
(none)
787
1
2
5
158.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brief Check Your Drinking (CYD)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
787 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Evaluating the Efficacy of a Brief Online Intervention Among Current Heavy Drinkers
Actual Study Start Date :
Mar 2, 2023
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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

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

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. Number of drinks consumed during a typical week [Three months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 King's College London London United Kingdom WC2R 2LS

Sponsors and Collaborators

  • King's College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
King's College London
ClinicalTrials.gov Identifier:
NCT05767567
Other Study ID Numbers:
  • HR-22/23-34937
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2023