Condition category
Mental and Behavioural Disorders
Date applied
04/10/2013
Date assigned
16/04/2014
Last edited
08/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This is an initial investigation before a much larger study. We want to find out if an online alcohol treatment programme called HELP-Drink (Healthy Living for People who Drink), which mirrors a face-to-face alcohol treatment provided at a Community Alcohol Service (CAS), is as effective and acceptable as the face-to-face treatment, for people who drink too much alcohol.

Who can participate?
Adults, referred by a health professional or self-referred, willing and able to use an online treatment, can participate.

What does the study involve?
Participants will be randomly allocated to one of two groups: HELP-Drink or usual face-to-face treatment by specialist alcohol workers. Those allocated to HELP-Drink will receive access to the online programme and those allocated to usual face-to-face treatment will have to make weekly visits to see the specialist. All participants will be asked to complete a questionnaire after completion of the study.

What are the possible benefits and risks of participating?
This online programme provides high quality information on alcohol use with methods to help people cut down or stop drinking. This programme offers additional support of facilitated access to the website. It also provides prompts via email/text/phone call to encourage participants to use the website. Participants need not attend appointments, which incur travel costs. There is the potential risk of patients reading information that they are not expecting. With this particular website, this risk is reduced firstly because users are able to use the website selectively by only accessing information which is of interest to them, and secondly because information on the website is provided with additional support linking the participant to a dedicated alcohol counsellor, who is able to refer to more intensive services if required. Participants do have to meet the costs of internet access either through their existing home Internet arrangements, or at public internet access points such as internet cafes, however participants will be signposted to local facilities which provide free Internet access.

Where is the study run from?
Research Department of Primary Care and Population Health, University College London (UK).

When is the study starting and how long is it expected to run for?
The study starts in May 2014 and runs for 30 months.

Who is funding the study?
National Institute for Health Research (NIHR), UK.

Who is the main contact?
Dr Fiona Hamilton
f.hamilton@ucl.ac.uk

Trial website

http://www.downyourdrink.org.uk/

Contact information

Type

Scientific

Primary contact

Prof Elizabeth Murray

ORCID ID

Contact details

Research Department of Primary Care and Population Health
University College London
Upper Floor 3
Royal Free Hospital
Rowland Hill Street
London
NW3 2PF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled feasibility trial of a web-based intervention to reduce consumption in people with 'hazardous and harmful' alcohol intake compared with a face-to-face intervention

Acronym

Study hypothesis

The overall aim of the trial is to determine the most cost-effective and acceptable method of delivering interventions to hazardous or harmful drinkers referred, or self-referred, to Community Alcohol Services (CAS). We intend to compare two methods of delivering interventions of proven effectiveness: (i) facilitated access to a web-based programme (comprising Motivational Interviewing, Behavioural Self Control, Cognitive Behavioural Therapy and Relapse Prevention) or (ii) usual CAS face-to-face treatment.
Our null hypothesis is that both delivery methods will be equally effective.

Ethics approval

London Bloomsbury NRES Committee, 16/06/2014, ref:14/LO/0664, amendment approved 22/09/2014

Study design

Randomised controlled feasibility trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hazardous or harmful alcohol use

Intervention

Potential participants will be patients referred or self-referred to participating community alcohol services. They will attend the CAS for their first assessment appointment with an alcohol counsellor as usual, where the counselor will record baseline measures including previous week's alcohol consumption and current levels of anxiety. If at the end of the assessment appointment the counsellor decides the patient meets the inclusion criteria to enter the trial, they will tell them about the trial and give them a participant information sheet. Interested eligible patients will then be consented by the alcohol counsellor at the end of their assessment appointment, and also asked for consent for the trial manager to contact them by phone or text after a 24-hour 'cooling off' period to see if they still want to participate in the trial (see patient information sheet and consent form).

If they do still want to participate in the trial they will be randomised by computer to HELP-Drink or face-to-face treatment at the CAS, and given a date for the facilitated introduction to the website at a convenient location, or for treatment as usual at the CAS.
1. Participants randomised to HELP-Drink will access one online module a week for six weeks, supported by tailored text messages and/or phone calls.
2. Participants randomised to face-to-face treatment will attend weekly for the standard number of appointments (usually six).

At 90 days after completing their treatment programmes, all participants will be contacted by email to complete online outcome measure questionnaires (including a measure of satisfaction with the intervention and whether they dropped out of the treatment to which they were randomised).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The outcomes examined at three months and 12 months will be:
1. Recruitment
2. Study attrition
3. Change in unit consumption of alcohol per week (using TOT-AL, an on-line beverage-specific measure which requires participants to enter the type and quantity of alcohol drinks consumed on each day of the past week)

Secondary outcome measures

1. Demographic and clinical characteristics will be recorded at baseline, which will enable us to determine if there are inequalities in access to the online alcohol programme

Secondary outcomes examined at three months and 12 months will be:
2. Change in participant satisfaction with care (measured using the 8-item Client Satisfaction Questionnaire (CSQ-8)
3. Change in Hospital Anxiety and Depression scale
4. Change in well-being scores (using EQ-5D)
5. Health professional time (A proforma will be used to record health professional time in minutes taken in both interventions, including failed encounters)

Overall trial start date

28/03/2013

Overall trial end date

03/02/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants will be hazardous and harmful drinkers in north London, identified using a validated screening tool such as AUDIT, referred from primary care, secondary care, or self-referred, to CAS.
2. Patients aged 18 or over at time of screening
3. Diagnosis of an alcohol use disorder using AUDIT criteria (score 8 or over)
4. Residing in a stable place of residence
5. Providing informed consent for randomisation, treatment and follow-up
6. Patients without prior internet experience, or without home access to the internet will be included, but will be offered additional training as part of their facilitated access to DYD.
All participants will be given information about local free or low-cost public internet access points, such as libraries, health centres and cluster rooms.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 200 patients

Participant exclusion criteria

1. Patients undergoing treatment for substance use or primary drug dependence (excluding nicotine) in the past 90 days
2. Already receiving help for an alcohol use disorder
3. Outstanding legal issues likely to lead to imprisonment
4. Severe mental or physical illness likely to preclude active participation in treatment or follow-up
5. Severe physical dependency on alcohol (LDQ > 20)
6. Unable to consult in English without an interpreter
7. Pregnancy
8. Patients with severe physical dependency or severe and complex co-existing physical or mental health problems will be referred for Tier 4 services in line with DH guidelines
9. Patients at risk of high risk of self-harm or suicide will not be excluded, but will be referred back to their GP for additional help

Recruitment start date

03/03/2014

Recruitment end date

01/10/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

HAGA - Action on Alcohol
171 Park Lane
London
N17 0HJ
United Kingdom

Trial participating centre

CASA - CASA Alcohol - Blenheim CDP
332C Goswell Road
London
EC1V 7LQ
United Kingdom

Trial participating centre

CGL (Change, grow, live - formerly CRI)
184 Royal College Street Camden
London
NW1 9NN
United Kingdom

Trial participating centre

Primary Care Alcohol & Drug Services (PCADS)
15b Hornsey Street
London
N7 8GG
United Kingdom

Trial participating centre

The Whittington Hospital
Magdala Avenue
London
N19 5NF
United Kingdom

Trial participating centre

University College London Hospital
2bu, 235 Euston Road
London
NW1 2BU
United Kingdom

Trial participating centre

Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom

Trial participating centre

North Middlesex Hospital
Sterling Way
London
N18 1QX
United Kingdom

Trial participating centre

Barnet Hospital
Wellhouse Lane
Barnet
EN5 3DJ
United Kingdom

Sponsor information

Organisation

University College London (UCL)/Royal Free London NHS Foundation Trust (UK)

Sponsor details

Joint Research Office
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 3447 5557
rfh.randd@nhs.net

Sponsor type

University/education

Website

http://www.ucl.ac.uk/jro/index

Funders

Funder type

Government

Funder name

University College London (UCL) Partners/national Institute for Health Research (NIHR) CLAHRC (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of the study results in a high-impact peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from help-alcohol@ucl.ac.uk

Intention to publish date

03/02/2018

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.pilotfeasibilitystudies.com/content/1/1/28/abstract

Publication citations

Additional files

Editorial Notes

08/12/2016: The following changes have been made to the record: 1. The overall trial dates have been updated from 03/03/2014 - 31/12/2015 to 28/03/2013 - 03/02/2017 and the recruitment end date has been updated from 31/12/2015 to 01/10/2016 2. The publication and dissemination plan and availability of participant level data have been added 3. The trial participating centres have been added