Title: A feasibility study of an intervention for structured preparation before detoxification in alcohol dependence: the SPADe trial.
Funder: Department of Health and Social Care

Abstract: Alcohol remains the most widely used substance in the UK. Dependence on alcohol represents the most severe end of the spectrum of alcohol use disorders, associated with a multitude of health problems and increased mortality. Evidence suggests that rushed detoxifications are not effective and lead to immediate relapses. Current treatment guidelines support the provision of planned detoxification followed by structured aftercare based on Cognitive Behaviour Therapy and attendance at mutual aid groups. Empirical evidence however, suggests that only a proportion of people with alcohol dependence engage in structured aftercare. Furthermore there is accumulating evidence for the adverse impact of repeated detoxification treatments on the brain, with associated reduction of treatment effectiveness over time. Recent empirical evidence suggests that adding a period of structured preparation prior to detoxification increase treatment engagement and short term treatment outcome. Preparatory interventions aim to stabilise the amount and pattern of drinking and intitiate aftercare work prior to detoxification. However, the value of structured preparation on short and longer term outcomes has not been robustly tested. Aims: The aim of this project is to assess the feasibility of evaluating a group intervention (Structured Preparation for Alcohol Detoxification: SPADe) for adults with moderate to severe alcohol dependence seeking abstinence and attending public alcohol community services, so that a fully powered randomised controlled trial (RCT) can be properly planned and efficiently carried out. SPADe groups as an adjunct to usual care will be compared with usual care (no structured preparation). Qualitative interviews will also be conducted with service users, carers and service providers to assess acceptability of SPADe. Methods: Based on the MRC guidelines for complex interventions we propose a three stage design: Adaptation and development of the content and related materials of previous implementations of the intervention to carry out the feasibility trial within recovery orientated services. The feasibility study is a pragmatic RCT of two parallel arms. Fifty people seeking abstinence will be recruited. Assessments of the participants will be conducted at baseline, 3, 6 months and 12 months from randomisation. Feasibility outcomes include recruitment and retention rates, fidelity of intervention provided, compliance with the intervention, data collection and completeness over 12 months. A variety of primary and secondary outcomes will be tested. A cost effectiveness analysis will be undertaken within the period of the trial, at the 12 month end point, with QALYs as the primary economic outcome. A selected sample of patients, carers and staff will be interviewed to establish their experiences of participating in the research. Questions to SPADe participants, carers and providers will include how the intervention is perceived, what barriers could impede successful implementation and how to overcome them. Potential benefits: The findings from this study will inform the design of a definitive large scale RCT to test the effectiveness and cost effectivenessefficacy of SPADe groups. SPADe group intervention will be refined in line with the findings from this study and materials will be made available to NHS, third sector and private providers. This will inform and alert providers about a change of the treatment paradigm for alcohol dependence, with focus on enhancing treatment safety and improving long term outcomes, with associated improvements in health and quality of life of patients and their families and reduction of NHS and wider social costs associated with chronic alcohol misuse and dependence.

Lay abstract: Alcohol-related problems are widespread in England. Those most severely affected are dependent drinkers, who have lost control over drinking and need alcohol in order to function every day. Current research tells us that rushed attempts to stop using alcohol (detoxifications) do not help patients to stay off alcohol for the rest of their lives. It may be also harmful going through many detoxes and make future attempts to stop drinking even harder. It is important that patients get treatment before being detoxed that gives them the best chance of achieving long term abstinence . Clinicians have developed a group programme to prepare dependent patients before detox. The aim of the programme is to stabilise drinking, to support patients to prepare for a new life without alcohol and to encourage them to attend support after the detox. Small studies have already been done suggesting that this programme is working and that patients are happy to take part. We plan to conduct a large trial to assess properly if this group programme is effective and suitable for widespread use. But before we do this, we want to make sure the trial will run smoothly. This application is therefore for a feasibility study. Alcohol dependent patients who attend NHS alcohol community services and agree to take part will be randomised (as if by the throw of a dice ) to either take part in the detox preparation group programme, or to carry on receiving usual care (no group preparation). We will investigate if patients can be recruited and retained in the study, and whether the questionnaires we have chosen are acceptable. We will examine what patients, carers and service providers thought of the programme using detailed interviews. The study will last for 30 months. Our findings will ensure the larger trial is designed properly.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: ORAL AND GASTROINTESTINAL;CANCER AND NEOPLASMS;CARDIOVASCULAR;STROKE