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
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
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.
London Bloomsbury NRES Committee, 16/06/2014, ref:14/LO/0664, amendment approved 22/09/2014
Randomised controlled feasibility trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Hazardous or harmful alcohol use
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).
Primary outcome measures
The outcomes examined at three months and 12 months will be:
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
Overall trial end date
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.
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
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
Recruitment end date
Countries of recruitment
Trial participating centre
University College London
University College London (UCL) Partners/national Institute for Health Research (NIHR) CLAHRC (UK)
Funding Body Type
Funding Body Subtype
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
2015 protocol in: http://www.pilotfeasibilitystudies.com/content/1/1/28/abstract