Clinical effectiveness of the psychological therapy Mental Health Intervention for Children with Epilepsy in addition to usual care compared with assessment-enhanced usual care alone: a multicentre, randomised controlled clinical trial in the UK.

Autor:	Bennett SD; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK; Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. Electronic address: sophie.bennett.10@ucl.ac.uk., Cross JH; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK; Young Epilepsy, Surrey, UK., Chowdhury K; Comprehensive Clinical Trials Unit, University College London, London, UK., Ford T; Department of Psychiatry, Cambridge University, Cambridge, UK; Cambridge and Peterborough NHS Foundation Trust, Cambridge, UK., Heyman I; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK; Cambridge and Peterborough NHS Foundation Trust, Cambridge, UK., Coughtrey AE; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Dalrymple E; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Byford S; Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK., Chorpita B; Department of Psychology, UCLA, California, LA, USA., Fonagy P; Division of Psychology & Language Sciences, University College London, London, UK., Moss-Morris R; Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK., Reilly C; Young Epilepsy, Surrey, UK., Smith JA; School of Psychological Sciences, Birkbeck, University of London, London, UK., Stephenson T; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Varadkar S; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Blackstone J; Comprehensive Clinical Trials Unit, University College London, London, UK., Quartly H; Comprehensive Clinical Trials Unit, University College London, London, UK., Hughes T; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Lewins A; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Moore E; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Walji F; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Welch A; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Whelan E; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Zacharia A; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., D'Oelsnitz A; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Shah M; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Xu L; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Vezyroglou A; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Mitchell K; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK., Nizza IE; School of Psychological Sciences, Birkbeck, University of London, London, UK., Ganguli P; Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK., Shafran R; UCL Great Ormond Street Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, UK.
Jazyk:	angličtina
Zdroj:	Lancet (London, England) [Lancet] 2024 Mar 30; Vol. 403 (10433), pp. 1254-1266. Date of Electronic Publication: 2024 Mar 07.
DOI:	10.1016/S0140-6736(23)02791-5
Abstrakt:	Background: Mental health difficulties are common in children and young people with chronic health conditions, but many of those in need do not access evidence-based psychological treatments. The study aim was to evaluate the clinical effectiveness of integrated mental health treatment for children and young people with epilepsy, a common chronic health condition known to be associated with a particularly high rate of co-occurring mental health difficulties. Methods: We conducted a parallel group, multicentre, open-label, randomised controlled trial of participants aged 3-18 years, attending epilepsy clinics across England and Northern Ireland who met diagnostic criteria for a common mental health disorder. Participants were randomised (1:1; using an independent web-based system) to receive the Mental Health Intervention for Children with Epilepsy (MICE) in addition to usual care, or assessment-enhanced usual care alone (control). Children and young people in both groups received a full diagnostic mental health assessment. MICE was a modular psychological intervention designed to treat common mental health conditions in children and young people using evidence-based approaches such as cognitive behaviour therapy and behavioural parenting strategies. Usual care for mental health disorders varied by site but typically included referral to appropriate services. Participants, along with their caregivers, and clinicians were not masked to treatment allocation but statisticians were masked until the point of analysis. The primary outcome, analysed by modified intention-to-treat, was the parent-report Strengths and Difficulties Questionnaire (SDQ) at 6 months post-randomisation. The study is complete and registered with ISRCTN (57823197). Findings: 1401 young people were potentially deemed eligible for study inclusion. Following the exclusion of 531 young people, 870 participants were assessed for eligibility and completed the SDQ, and 480 caregivers provided consent for study inclusion between May 20, 2019, and Jan 31, 2022. Between Aug 28, 2019, and Feb 21, 2022, 334 participants (mean ages 10·5 years [SD 3·6] in the MICE group vs 10·3 [4·0] in control group at baseline) were randomly assigned to an intervention using minimisation balanced by age, primary mental health disorder, diagnosis of intellectual disability, and autistic spectrum disorder at baseline. 168 (50%) of the participants were female and 166 (50%) were male. 166 participants were randomly assigned to the MICE group and 168 were randomly assigned to the control group. At 6 months, the mean SDQ difficulties for the 148 participants in the MICE group was 17·6 (SD 6·3) and 19·6 (6·1) for the 148 participants in the control group. The adjusted effect of MICE was -1·7 (95% CI -2·8 to -0·5; p=0·0040; Cohen's d, 0·3). 14 (8%) patients in the MICE group experienced at least one serious adverse event compared with 24 (14%) in the control group. 68% percent of serious adverse events (50 events) were admission due to seizures. Interpretation: MICE was superior to assessment-enhanced usual care in improving symptoms of emotional and behavioural difficulties in young people with epilepsy and common mental health disorders. The trial therefore shows that mental health comorbidities can be effectively and safely treated by a variety of clinicians, utilising an integrated intervention across ages and in the context of intellectual disability and autism. The evidence from this trial suggests that such a model should be fully embedded in epilepsy services and serves as a model for other chronic health conditions in young people. Funding: UK National Institute for Health Research Programme Grants for Applied Research programme and Epilepsy Research UK Endeavour Project Grant. Competing Interests: Declaration of interests JB was funded in part by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research (PGfAR) to work on the MICE project in his substantive employment as a Clinical Project Manager at the UCL Comprehensive Clinical Trials Unit. RM-M and SV were funded by NIHR PGfAR. RS was funded by NIHR PGfAR with payment going to UCL for her time on the project. SB was funded by NIHR PGfAR with payments made to her institution King's College London. SDB was funded by NIHR PGfAR to work on the MICE project in her substantive employment as Principal Research Fellow at UCL. BC has received grants from the William T Grant Foundation, Wellcome Trust, and National Institute of Mental Health as principal investigator or co-principal investigator. JHC has received grants from Stoke Therapeutics, Ultragenyx, NIHR, Great Ormond Street Hospital Children's Charity, LifeARC, Waterloo Foundation, and Action Medical Research. SDB has received grants from Epilepsy Research UK and NIHR PGfAR. SV has received grants from the NIHR. RM-M has received grants from MS Society, Crohn's and Colitis UK, and NIHR. BC receives royalties from MATCH-ADTC. PF receives royalties from books with Guildford Press, American Psychiatric Publishing, Oxford University Press. SDB and RS receive royalties from Oxford University Press. RM-M is a beneficiary of license between King's College London and Mahana Therapeutics and has received consulting fees from Mahana Therapeutics and 11 London. PF's honoraria payments for lectures, presentations, and workshops are sent to the Anna Freud centre and he does not receive direct payment for them. JHC's honoraria payments from Biocodex, Nutricia, Jazz Pharmaceuticals, Takeda, and UCB are sent to UCL. SV's honoraria payments from LivaNova for speaking engagements are sent to Great Ormond Street Hospital. RM-M has received payment or honoraria from the European Association of Psychosomatic Medicine, British Association for Behavioural and Cognitive Psychotherapies, and Central and North West London NAtional Health Service (NHS) Foundation Trust. BC received support for attending the OMNI Inventive Care Omaha conference, a children's mental health gathering. TS was reimbursed for travel costs to the annual Royal College of Paediatrics & Child Health Meeting attending to present trial findings. RM-M has received support for attending meetings and for travel from the American Psychosomatic Society, European Association of Psychosomatic Medicine, and British Association for Behavioural and Cognitive Psychotherapies. JHC does not receive personal remuneration for participation in data safety and monitoring boards for Stoke Therapeutics. SV's remuneration for participation in data safety and monitoring boards for advisory board participation from Biocodex is sent to GOSH. BC is a board member of PracticeWise, which owns the MATCH-ADTC protocol on which the Mental Health Intervention for Children with Epilepsy programme is based. PracticeWise was paid for training and consulting during the trial setup phase, and provided supervision of the study supervisors to ensure integrity of treatment implementation. JHC is the Elected President for the International League Against Epilepsy, Chair Medical Board for Matthews Friends, Chair of Medical Board for Dravet UK, Chair of Medical Board for Hope for Hypothalamic Hamartoma, and President of Epilepsy Research UK. PF is Chief Executive of the Anna Freud National Centre for Children and Families, Director for Mental Health and Behaviour Change Programmes for UCLPartners, and National Senior Clinical Advisor for Children and Young People's mental health at NHS England. RS is a director of Bespoke Mental Health. SDB is a psychologist in private practice and a co-director of Mind and Body London. BC did not interact with participants or study therapists and was not involved in the analysis. TS was not involved with the research ethics application for this study. All other authors declare no competing interests. (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)
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