Abstract
Background“Hazardous and harmful” drinkers make up approximately 23 % of the adult population in England. However, only around 10 % of these people access specialist care, such as face-to-face extended brief treatment in community alcohol services. This may be due to stigma, difficulty accessing services during working hours, a shortage of trained counsellors and limited provision of services in many places. Web-based alcohol treatment programmes may overcome these barriers and may better suit people who are reluctant or unable to attend face-to-face services, but there is a gap in the evidence base for the acceptability, effectiveness and cost-effectiveness of these programmes compared with treatment as usual (TAU) in community alcohol services.This study aims investigate the feasibility of all parts of a randomised controlled trial (RCT) of a psychologically informed web-based alcohol treatment programme called Healthy Living for People who use Alcohol (HeLP-Alcohol) versus TAU in community alcohol services, e.g. recruitment and retention, online data collection methods, and the use and acceptability of the intervention to participants.MethodsA feasibility RCT delivered in north London community alcohol services, comparing HeLP-Alcohol with TAU. Potential participants are aged ≥18 years referred or self-referred for hazardous and harmful use of alcohol, without co-morbidities or other complex problems. The main purpose of this study is to demonstrate the feasibility of recruiting participants to the study and will test online methods for collecting baseline demographic and outcome questionnaire data, randomising participants and collecting 3-month follow-up data. The acceptability of this intervention will be measured by recruitment and retention rates, automated log-in data collection and an online service satisfaction questionnaire. The feasibility of using tailored text message, email or phone prompt to maintain engagement with the intervention will also be explored. Results of the study will inform a definitive Phase 3 RCT.ResultsRecruitment started on 26 September 2014 and will run for 1 year.ConclusionThe proposed trial will provide data to inform a fully powered non-inferiority effectiveness and cost-effectiveness RCT comparing HeLP-Alcohol with TAU.Trial registrationISRCTN31789096.
Highlights
Alcohol is the second biggest lifestyle risk factor for disease and premature mortality after smoking [1]
Alcohol misuse is estimated to cost the United Kingdom (UK) around £21 billion per year [2, 3]. This includes National Health Service (NHS) costs for treating accidents, assaults resulting from alcohol intoxication, conditions such as liver disease, cardiovascular disease and cancers, and the cost of alcohol treatment services
Aims of the trial The overall aim of this study is to determine the feasibility of conducting a randomised controlled trial (RCT) comparing supported access to a web-based Tier 2/3 treatment called Healthy Living for People who use Alcohol (HeLP-Alcohol) with usual care
Summary
Design This is a randomised controlled feasibility trial. Setting The London boroughs of Camden, Islington and Haringey have agreed to participate in the study, and we have recruited four community alcohol services to take part. 2. Retention measured by completeness of online data collection for each arm at baseline and at 3 months as a percentage of patients randomised. 5. Outcome measures to be collected at 3 months: (a) Adherence to the intervention (for those randomised to this arm), measured through automated recording of numbers of log-ins and numbers of pages visited at each log-in (b) Other sources of support accessed during treatment (e.g. group therapy; horticulture; acupuncture; art therapy; other therapies) (c) Participant satisfaction with care (measured using the 8-item Client Satisfaction Questionnaire (CSQ-8), developed as a measure of satisfaction for mental health services, [26, 27] and used for assessing satisfaction with alcohol and other substance misuse programme) [28]. Recruitment will run for 1 year, with data collection complete by end-December 2015
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