Christos Kouimtsidis1, Ben Houghton2, Heather Gage3, Caitlin Notley4, Vivienne Maskrey5, Allan Clark5, Richard Holland6, Anne Lingford-Hughes7, Bhaskar Punukollu8, Morro Touray4, Theodora Duka9. 1. Surrey & Borders NHS Trust, Research and Development, Abraham Cowley Uni, Chertsey, Surrey, KT16 0AE, UK. drckouimtsidis@hotmail.com. 2. Surrey & Borders NHS Trust, Research and Development, Abraham Cowley Uni, Chertsey, Surrey, KT16 0AE, UK. 3. University of Surrey, 388 Stag Hill, Guildford, GU2 7XH, UK. 4. Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich, NR4 7TJ, UK. 5. University of East Anglia, Norwich Research Park, Norwich, NR4 7TJ, UK. 6. University of Leicester, University Road, Leicester, LE1 7RH, UK. 7. Imperial College London, Burlington Danes Building, Hammersmith Campus, 160 Du Cane Road, London, W12 0NN, UK. 8. Camden and Islington NHS Foundation Trust, St Pancras Hospital, 4 St Pancras Way, Kings Cross, London, NW1 0PE, UK. 9. University of Sussex, School of Psychology, Falmer, Brighton, BN1 9RH, UK.
Abstract
BACKGROUND: 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. 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? METHODS: This 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. RESULTS: We 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). CONCLUSIONS: The 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 REGISTRATION: Name of registry: ISRCTN; Trial Registration Number: 14621127 ; Date of Registration: 22/02/2017.
RCT Entities:
BACKGROUND: 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. 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? METHODS: This 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. RESULTS: We 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). CONCLUSIONS: The 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 REGISTRATION: Name of registry: ISRCTN; Trial Registration Number: 14621127 ; Date of Registration: 22/02/2017.
Authors: Amy Peacock; Janni Leung; Sarah Larney; Samantha Colledge; Matthew Hickman; Jürgen Rehm; Gary A Giovino; Robert West; Wayne Hall; Paul Griffiths; Robert Ali; Linda Gowing; John Marsden; Alize J Ferrari; Jason Grebely; Michael Farrell; Louisa Degenhardt Journal: Addiction Date: 2018-06-04 Impact factor: 6.526
Authors: Theodora Duka; Leanne Trick; Kyriaki Nikolaou; Marcus A Gray; Matthew J Kempton; Hugh Williams; Steven C R Williams; Hugo D Critchley; David N Stephens Journal: Biol Psychiatry Date: 2011-05-25 Impact factor: 13.382