A feasibility trial of an intervention in alcohol dependence for structured preparation before detoxification versus usual care: the SPADe trial results

Christos Kouimtsidis,Heather Gage,Caitlin Notley,Vivienne Maskrey,Ben Houghton,Bhaskar Punukollu,Richard Holland,Anne Lingford-Hughes,Theodora Duka,Morro Touray,Allan Clark

doi:10.1186/s40814-021-00880-6

Abstract

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 but outcomes are poor with low proportions engaging in after care and high relapse rates. An approach of structured preparation before alcohol detoxification (SPADe) puts an 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 SPADe and usual care against usual care only in maintaining alcohol abstinence in adults with alcohol dependence receiving care in two community addiction services in London. Feasibility outcomes, exploration of primary and secondary clinical outcomes and health economic outcomes are analysed. 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 for the whole period of the 12 months 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).ConclusionsThe results of this feasibility trial indicate that with the appropriate modifications, a full multicentred 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.

Highlights

Individuals 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 and to have economic and social implications [2]
Aim The key research question was: can we design a large scale, randomised controlled trial (RCT) that will answer whether the structured preparation before alcohol detoxification (SPADe) intervention is more effective than usual care in helping adults to maintain longer periods of alcohol abstinence? The feasibility trial compared the use of SPADe with usual care against usual care alone in two sites and enabled us to do the following: 1. Measure the number of eligible participants, willingness of clinicians to recruit participants, recruitment rate, loss to follow-up, adherence to the intervention and standard deviation of the primary outcome measures
We have suggested that the task creates a conflict between abstaining and responding for reward similar to that experienced by the participants before relapse, and that the impaired ability of multiple-detoxified participants to perform the task accurately reflects the consequences of detoxification on top-down control of their behaviour [9]

Summary

Introduction

Individuals 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. An approach of structured preparation before alcohol detoxification (SPADe) puts an 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. In the UK, hospital admissions attributable to alcohol in 2017– 2018 remained similar to the previous year (338,000) This is 15% higher than 10 years ago [3]. This follows large year-on-year declines from a peak of 91,651 in 2013 to 2014 [4]

Methods

Results

Discussion

Conclusion