Down Your Drink: On-line Randomised Controlled Trial of an Interactive Web-based Intervention for Reducing Alcohol Consumption

ISRCTN	ISRCTN31070347
DOI	https://doi.org/10.1186/ISRCTN31070347
Protocol serial number	G0501298
Sponsor	University College London (UK)
Funder	National Prevention Research Initiative (NPRI) (UK)

Submission date: 19/04/2006
Registration date: 06/06/2006
Last edited: 23/11/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paul Wallace
Scientific

Department of Primary Care and Population Sciences
University College London
Archway Campus
Level 2
Holborn Union Building
London
N19 5LW
United Kingdom

Email	p.wallace@pcps.ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Complex intervention study, incorporating a phase II development stage, together with a pilot phase and a phase III, two-arm randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DYD
Study objectives	The aim of the study is to determine whether the fully interactive on-line intervention, Down Your Drink (DYD), leads to important reductions in alcohol consumption amongst members of the public at risk of harm from alcohol. Please note that this trial was updated on 29/04/2008. All changes can be found in the relevant field under the above update date.
Ethics approval(s)	Ethics approval received from the University College London Research Ethics Committee on the 26 April 2007 (ref: 0825/003).
Health condition(s) or problem(s) studied	Alcohol consumption
Intervention	Intervention website - DYD interactive web-based intervention, providing motivational enhancement therapy and cognitive behaviour therapy versus comparator website - Hows Your Drink (HYD), a minimally interactive website, providing information only.
Intervention type	Other
Primary outcome measure(s)	Current primary outcome measures as of 29/04/2008: Data from 3 and 12-month follow-up will be analysed separately at the end of the trial. The primary end point is at 3 months. The primary outcome is reduction in alcohol consumption. The primary outcome measure will be total past weeks alcohol consumption. Previous primary outcome measures: Data from 3 and 12-month follow-up will be analysed separately at the end of the trial. The primary end point is at 3 months. The primary outcome is reduction in alcohol consumption. The primary outcome measure will be total past weeks alcohol consumption as calculated by quantity or frequency.
Key secondary outcome measure(s)	Added as of 29/04/2008: 1. AUDIT 2. Alcohol Problems Questionnaire (APQ) 3. Leeds Dependence Questionnaire (LDQ) 4. CORE-10
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	2600
Key inclusion criteria	Current inclusion criteria as of 29/04/2008: All participants aged 18 or over and scoring 5 or more on the AUDIT-C screening test. Previous inclusion criteria: All registrants of the How's Your Drink (HYD) website (aged 16 or over) with a functional assessment staging tool (FAST) score of 3 or more who consent to participate.
Key exclusion criteria	Current exclusion criteria as of 29/04/2008: 1. Research participants who are under 18 years of age 2. Inability to provide informed consent due to mental incapacity or active psychotic illness 3. Inability to use intervention independently due to visual, hearing or motor handicap 4. Inability to use intervention or to complete the follow-up questionnaires independently due to poor command of English Previous exclusion criteria: 1. Research participants who are under 16 years of age 2. Inability to provide informed consent due to mental incapacity or active psychotic illness 3. Inability to use intervention independently due to visual, hearing or motor handicap 4. Inability to use intervention or to complete the follow-up questionnaires independently due to poor command of English
Date of first enrolment	01/07/2006
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Primary Care and Population Sciences

London
N19 5LW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	02/03/2011	Yes	No
Results article	results	09/03/2011	Yes	No
Results article	results	18/11/2011	Yes	No