Condition category
Mental and Behavioural Disorders
Date applied
19/04/2006
Date assigned
06/06/2006
Last edited
23/11/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 - How’s 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 week’s 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 week’s 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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes