A Feasibility Study of an Intervention for Structured Preparation Before Detoxification in Alcohol Dependence: the SPADe Trial Results

BackgroundIndividuals who are ‘moderately’ or ‘severely’ dependent consume alcohol at levels that are likely to have a severe impact on their own health and mortality, the health and behaviours of others (family members), and to have economic and social implications. Treatment guidelines suggest that treatment needs to be planned with medically assisted withdrawal (also referred to as detoxification), and aftercare support. Treatment outcomes are poor with low proportions engaging in after care and high relapse rates. An approach of structured preparation before alcohol detoxification (SPADe) put emphasis on introducing lifestyle changes, development of coping strategies for cravings, stress and emotions as well as introducing changes to the immediate family and social environment in advance of alcohol cessation. Such a pre-habilitation paradigm compliments the established treatment approach. The key research question was: can we design a large scale, randomised controlled trial (RCT) that will answer whether such an approach is more effective than usual care in helping individuals to maintain longer periods of alcohol abstinence?MethodsThis is a pragmatic, parallel, two-arm, feasibility RCT comparing the clinical and cost-effectiveness of SPADe and usual care against usual care only in maintaining alcohol abstinence in adults with alcohol dependence receiving care in two community services in London. The trial follows the guidelines of phase 2 of the Medical Research Council (MRC) for complex interventions. ResultsWe were able to recruit 48/50 participants during a period of 9 months. Retention in the trial was 75%. Treatment compliance was overall 44%. Data completion for the primary outcome was 65%, 50% and 63% at 3, 6 and 12 months respectively. The intervention group had more days abstinent in the previous 90 days at the 12 months (n=54.5) versus control (n=41.5). DiscussionThe results of this feasibility trial indicate that with the appropriate modifications, a full multi centred trial would be possible to test the effectiveness and cost-effectiveness of a pre- habilitation approach such as the SPADe group intervention in addition to usual care against usual care only.Trial RegistrationName of registry: ISRCTN; Trial Registration Number: 14621127; Date of Registration: 22/02/2017; URL of trial registry record: http://www.isrctn.com/ISRCTN14621127