Study protocol for a randomised controlled trial of CBT vs antipsychotics vs both in 14–18-year-olds: Managing Adolescent first episode Psychosis: a feasibility study (MAPS)
Melissa Pyle,
Matthew R. Broome,
Emmeline Joyce,
Graeme MacLennan,
John Norrie,
Daniel Freeman,
David Fowler,
Peter M. Haddad,
David Shiers,
Chris Hollis,
Jo Smith,
Ashley Liew,
Rory E. Byrne,
Paul French,
Sarah Peters,
Jemma Hudson,
Linda Davies,
Richard Emsley,
Alison Yung,
Max Birchwood,
Eleanor Longden,
Anthony P. Morrison
Affiliations
Melissa Pyle
The Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust
Matthew R. Broome
Institute for Mental Health, School of Psychology, University of Birmingham
Emmeline Joyce
The Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust
Graeme MacLennan
Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen
John Norrie
Edinburgh Clinical Trials Unit, Centre for Population Health Sciences, Usher Institute, Nine Edinburgh BioQuarter
Daniel Freeman
Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital
David Fowler
School of Psychology, Pevensey Building, University of Sussex
Peter M. Haddad
The Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust
David Shiers
The Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust
Chris Hollis
NIHR MindTech MedTech Co-operative, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham
Jo Smith
School of Allied Health and Community, Bredon Building, University of Worcester
Ashley Liew
Institute for Mental Health, School of Psychology, University of Birmingham
Rory E. Byrne
The Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust
Paul French
The Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust
Sarah Peters
Division of Psychology and Mental Health, University of Manchester
Jemma Hudson
Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen
Linda Davies
Division of Population Health, Health Services Research & Primary Care, University of Manchester
Richard Emsley
Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King’s College London
Alison Yung
The Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust
Max Birchwood
Warwick Medical School-Mental Health and Wellbeing, University of Warwick
Eleanor Longden
The Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust
Anthony P. Morrison
The Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust
Abstract Background Adolescent-onset psychosis is associated with more severe symptoms and poorer outcomes than adult-onset psychosis. The National Institute for Clinical Excellence (NICE) recommend that adolescents with first episode psychosis (FEP) should be offered a combination of antipsychotic medication (APs), cognitive behavioural therapy (CBT) and family intervention (FI). The evidence for APs in treating psychosis is limited in adolescents compared to adults. Nevertheless, it indicates that APs can reduce overall symptoms in adolescents but may cause more severe side effects, including cardiovascular and metabolic effects, than in adults. CBT and FI can improve outcomes in adults, but there are no studies of psychological interventions (PI) in patients under 18 years old. Given this limited evidence base, NICE made a specific research recommendation for determining the clinical and cost effectiveness of APs versus PI versus both treatments for adolescent FEP. Methods/design The current study aimed to establish the feasibility and acceptability of conducting such a trial by recruiting 14–18-year-olds with a first episode of psychosis into a feasibility prospective randomised open blinded evaluation (PROBE) design, three-arm, randomised controlled trial of APs alone versus PI alone versus a combination of both treatments. We aimed to recruit 90 participants from Early Intervention and Child and Adolescent Mental Health Teams in seven UK sites. APs were prescribed by participants’ usual psychiatrists. PI comprised standardised cognitive behavioural therapy and family intervention sessions. Discussion This is the first study to compare APs to PI in an adolescent population with FEP. Recruitment finished on 31 October 2018. The study faced difficulties with recruitment across most sites due to factors including clinician and service-user treatment preferences. Trial registration Current controlled trial with ISRCTN, ISRCTN80567433. Registered on 27 February 2017.
