Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT05037630 - Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use N/A
Completed NCT03037749 - Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence N/A
Enrolling by invitation NCT02927132 - Guilt and Expressive Writing for Reducing Alcohol Use in College Students N/A
Completed NCT02905123 - Brief Internet Intervention for Hazardous Alcohol Use N/A
Enrolling by invitation NCT02952495 - Online Education to Inform the Elderly About Age-related Alcohol Risks Phase 2
Completed NCT01923246 - Development of IVR and WEB Alcohol Interventions N/A
Completed NCT01129804 - Network Support for Alcohol Treatment 2 N/A
Completed NCT00374153 - Southern Methodist Alcohol Research Trial (SMART) N/A
Completed NCT01126164 - Parent Intervention to Reduce Binge Drinking N/A
Completed NCT00383838 - Self-Selected Brief Alcohol Intervention for Adolescents N/A
Completed NCT03408743 - Engineering an Online STI Prevention Program: CSE2 N/A
Recruiting NCT04957628 - AlcoTail - Implementation of Tailored Interventions
Recruiting NCT04164940 - Patient Trajectories for Older Adults Admitted to Hospital for Alcohol-related Problems
Completed NCT00292240 - Brief Youth Substance Use Intervention for Primary Care N/A
Completed NCT04804579 - Boston ARCH 4F Intervention to Reduce Fall Risk in People With HIV and Alcohol Use N/A
Completed NCT02387489 - A Clinical Trial of SBIRT Services in School-based Health Centers N/A
Completed NCT02188446 - Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients N/A
Completed NCT01688245 - A Text Message Behavioral Intervention to Reduce Alcohol Consumption in Young Adults N/A
Withdrawn NCT01739842 - Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment Phase 2/Phase 3
Completed NCT00561587 - Quetiapine vs. Placebo in Alcohol Relapse Prevention - a Pilot Study Phase 2