Contact information
Type
Scientific
Primary contact
Prof Paul Wallace
ORCID ID
Contact details
Department of Primary Care and Population Sciences
University College London
Archway Campus
Level 2
Holborn Union Building
London
N19 5LW
United Kingdom
p.wallace@pcps.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0501298
Study information
Scientific title
Acronym
DYD
Study hypothesis
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
Ethics approval received from the University College London Research Ethics Committee on the 26 April 2007 (ref: 0825/003).
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
Added as of 29/04/2008:
1. AUDIT
2. Alcohol Problems Questionnaire (APQ)
3. Leeds Dependence Questionnaire (LDQ)
4. CORE-10
Overall trial start date
01/07/2006
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2600
Participant 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
Recruitment start date
01/07/2006
Recruitment end date
31/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Primary Care and Population Sciences
London
N19 5LW
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
University College London
Biomedicine Research and Development Unit
Hampstead Campus
London
NW3 2PF
United Kingdom
o.avwenagha@medsch.ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
National Prevention Research Initiative (NPRI) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21408060
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21371988
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22100793
Publication citations
-
Results
Wallace P, Murray E, McCambridge J, Khadjesari Z, White IR, Thompson SG, Kalaitzaki E, Godfrey C, Linke S, On-line randomized controlled trial of an internet based psychologically enhanced intervention for people with hazardous alcohol consumption., PLoS ONE, 2011, 6, 3, e14740, doi: 10.1371/journal.pone.0014740.
-
Results
Khadjesari Z, Murray E, Kalaitzaki E, White IR, McCambridge J, Thompson SG, Wallace P, Godfrey C, Impact and costs of incentives to reduce attrition in online trials: two randomized controlled trials., J. Med. Internet Res., 2011, 13, 1, e26, doi: 10.2196/jmir.1523.
-
Results
McCambridge J, Kalaitzaki E, White IR, Khadjesari Z, Murray E, Linke S, Thompson SG, Godfrey C, Wallace P, Impact of length or relevance of questionnaires on attrition in online trials: randomized controlled trial., J. Med. Internet Res., 2011, 13, 4, e96, doi: 10.2196/jmir.1733.