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

doi:10.1186/s13063-019-3506-1

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)

Trials. 2019 Jul 4;20(1):395. doi: 10.1186/s13063-019-3506-1.

Authors

Melissa Pyle^{1

2}, Matthew R Broome^{3

4

5

6}, Emmeline Joyce¹, Graeme MacLennan⁷, John Norrie⁸, Daniel Freeman^{9

10}, David Fowler¹¹, Peter M Haddad^{1

12}, David Shiers^{1

2}, Chris Hollis¹³, Jo Smith¹⁴, Ashley Liew^{15

16

17}, Rory E Byrne^{1

2}, Paul French^{1

18}, Sarah Peters², Jemma Hudson⁷, Linda Davies¹⁹, Richard Emsley²⁰, Alison Yung^{1

2

21}, Max Birchwood²², Eleanor Longden^{1

2}, Anthony P Morrison^{1

2}

Affiliations

¹ The Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust, Prestwich, M25 3BL, UK.
² Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, M13 9PL, UK.
³ Institute for Mental Health, School of Psychology, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. m.r.broome@bham.ac.uk.
⁴ Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK. m.r.broome@bham.ac.uk.
⁵ Centre for Human Brain Health, School of Psychology, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. m.r.broome@bham.ac.uk.
⁶ Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, OX4 7JX, UK. m.r.broome@bham.ac.uk.
⁷ Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, 3rd Floor Health Sciences Building, Aberdeen, AB25 2ZD, UK.
⁸ Edinburgh Clinical Trials Unit, Centre for Population Health Sciences, Usher Institute, Nine Edinburgh BioQuarter, 9 Little France Road, Edinburgh, EH16 4UX, UK.
⁹ Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK.
¹⁰ Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, OX4 7JX, UK.
¹¹ School of Psychology, Pevensey Building, University of Sussex, Falmer, BN1 9QH, UK.
¹² Department of Psychiatry, Hamad Medical Corporation, PO Box 3050, Doha, Qatar.
¹³ NIHR MindTech MedTech Co-operative, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham, Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.
¹⁴ School of Allied Health and Community, Bredon Building, University of Worcester, Worcester, WR2 6AJ, UK.
¹⁵ Institute for Mental Health, School of Psychology, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
¹⁶ Centre for Educational Development, Appraisal and Research, University of Warwick, Coventry, CV4 7AL, UK.
¹⁷ Forward Thinking Birmingham, Birmingham Women's and Children's NHS Foundation Trust, Finch Road, Lozells, B19 1HS, UK.
¹⁸ Institute of Psychology, Health and Society, University of Liverpool, Waterhouse Building, Liverpool, L69 3BX, UK.
¹⁹ Division of Population Health, Health Services Research & Primary Care, University of Manchester, Jean MacFarlane Building, Manchester, M13 9PL, UK.
²⁰ Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, Denmark Hill, London, SE5 8AZ, UK.
²¹ Centre for Youth Mental Health, Faculty of Medicine, University of Melbourne, 35 Poplar Rd, Parkville, Melbourne, VIC, 3052, Australia.
²² Warwick Medical School-Mental Health and Wellbeing, University of Warwick, Coventry, CV4 7AL, UK.

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.

Keywords: Adolescent psychosis; Antipsychotic medication; Cognitive behavioural therapy; Family intervention; First-episode psychosis; Psychological intervention; Randomised controlled trial; Schizophrenia.

Publication types

Clinical Trial Protocol

MeSH terms

Adolescent
Adolescent Behavior / drug effects*
Age Factors
Antipsychotic Agents / adverse effects
Antipsychotic Agents / therapeutic use*
Cognitive Behavioral Therapy*
England
Family Therapy*
Feasibility Studies
Female
Humans
Male
Multicenter Studies as Topic
Prospective Studies
Psychotic Disorders / diagnosis
Psychotic Disorders / psychology
Psychotic Disorders / therapy*
Randomized Controlled Trials as Topic
Time Factors
Treatment Outcome

Substances

Antipsychotic Agents

Abstract

Publication types

MeSH terms

Substances

Grants and funding