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 (Corresponding Author), 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 & 2 others Eleanor Longden, Anthony P Morrison

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article number395
JournalTrials
Volume20
DOIs
Publication statusPublished - 4 Jul 2019

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Feasibility Studies
Cognitive Therapy
Psychotic Disorders
Antipsychotic Agents
Randomized Controlled Trials
Psychology
Cost-Benefit Analysis
Psychiatry
Mental Health
Therapeutics
Research
Population

Keywords

  • CBT
  • antipsychotics
  • psychosis
  • Adolescent psychosis
  • Family intervention
  • Randomised controlled trial
  • Schizophrenia
  • First-episode psychosis
  • Cognitive behavioural therapy
  • Psychological intervention
  • Antipsychotic medication

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine (miscellaneous)

Cite this

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). / Pyle, Melissa; Broome, Matthew R (Corresponding Author); Joyce, Emmeline; MacLennan, Graeme; Norrie, John; Freeman, Daniel; Fowler, David; Haddad, Peter M; Shiers, David; Hollis, Chris; Smith, Jo; Liew, Ashley; Byrne, Rory E; French, Paul; Peters, Sarah; Hudson, Jemma; Davies, Linda; Emsley, Richard; Yung, Alison; Birchwood, Max; Longden, Eleanor; Morrison, Anthony P.

In: Trials, Vol. 20, 395, 04.07.2019.

Research output: Contribution to journalArticle

Pyle, M, Broome, MR, Joyce, E, MacLennan, G, Norrie, J, Freeman, D, Fowler, D, Haddad, PM, Shiers, D, Hollis, C, Smith, J, Liew, A, Byrne, RE, French, P, Peters, S, Hudson, J, Davies, L, Emsley, R, Yung, A, Birchwood, M, Longden, E & Morrison, AP 2019, '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, vol. 20, 395. https://doi.org/10.1186/s13063-019-3506-1
Pyle, Melissa ; Broome, Matthew R ; Joyce, Emmeline ; MacLennan, Graeme ; Norrie, John ; Freeman, Daniel ; Fowler, David ; Haddad, Peter M ; Shiers, David ; Hollis, Chris ; Smith, Jo ; Liew, Ashley ; Byrne, Rory E ; French, Paul ; Peters, Sarah ; Hudson, Jemma ; Davies, Linda ; Emsley, Richard ; Yung, Alison ; Birchwood, Max ; Longden, Eleanor ; Morrison, Anthony P. / 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). In: Trials. 2019 ; Vol. 20.
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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.",
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author = "Melissa Pyle and Broome, {Matthew R} and Emmeline Joyce and Graeme MacLennan and John Norrie and Daniel Freeman and David Fowler and Haddad, {Peter M} and David Shiers and Chris Hollis and Jo Smith and Ashley Liew and Byrne, {Rory E} and Paul French and Sarah Peters and Jemma Hudson and Linda Davies and Richard Emsley and Alison Yung and Max Birchwood and Eleanor Longden and Morrison, {Anthony P}",
note = "Acknowledgements Thank you to all the participants, family members/carers who agreed to take part in the trial and clinicians who have supported participant enrolment into the trial. This study was supported by the National Institute for Health Research (NIHR), the NIHR MindTech MedTech Co-operative, the NIHR Nottingham Biomedical Research Centre and the Clinical Research Network-Mental Health. MBi is part funded by NIHR CLAHRC West Midlands. We are grateful to the Psychosis Research Unit (PRU) Service User Reference Group (SURG) for their consultation regarding the design of the study and contribution to the developments of study-related materials. We are grateful to our Independent Trial Steering Committee and Independent Data Monitoring Committee for providing oversight of the trial. Funding MAPS was funded by the NIHR HTA programme (project number 15/31/04) and the final report will be published in Health Technology Assessment. Visit the HTA programme website for further project information. The Sponsor is Greater Manchester Mental Health NHS Foundation Trust, email R&D@gmmh.nhs.uk. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health. Authors’ contributions MP made substantial contribution to the development of the trial protocol and to the overall management of the trial and data management, and wrote the first draft of the manuscript. AL, AY, CH, DFo, DFr, DS, EL, LD, PF, SP, MBi, MBr and REB contributed to the application for funding, made substantial contribution to the design of the trial and protocol and critically read the manuscript. EJ contributed to the writing of the manuscript. GM made substantial contribution to the design of the trial, the protocol and the statistical analysis plan and critically read the manuscript. JN, RE contributed to the application for funding, made substantial contribution to the design of the trial, the protocol and the statistical analysis plan and critically read the manuscript. PH made substantial contribution to the design of the trial and protocol and critically read the manuscript. JS made a substantial contribution to the family intervention component of the protocol, provided FI supervision to therapists on the trial and contributed to the writing of the manuscript. JH made substantial contribution to the statistical analysis plan and critically read the manuscript. APM planned the study, contributed to the application for funding, made substantial contribution to the design of the trial protocol and the statistical analysis plan, managed the stud, and critically read the manuscript. All authors read and approved the final manuscript.",
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TY - JOUR

T1 - Study protocol for a randomised controlled trial of CBT vs antipsychotics vs both in 14-18-year-olds

T2 - Managing Adolescent first episode Psychosis: a feasibility study (MAPS)

AU - Pyle, Melissa

AU - Broome, Matthew R

AU - Joyce, Emmeline

AU - MacLennan, Graeme

AU - Norrie, John

AU - Freeman, Daniel

AU - Fowler, David

AU - Haddad, Peter M

AU - Shiers, David

AU - Hollis, Chris

AU - Smith, Jo

AU - Liew, Ashley

AU - Byrne, Rory E

AU - French, Paul

AU - Peters, Sarah

AU - Hudson, Jemma

AU - Davies, Linda

AU - Emsley, Richard

AU - Yung, Alison

AU - Birchwood, Max

AU - Longden, Eleanor

AU - Morrison, Anthony P

N1 - Acknowledgements Thank you to all the participants, family members/carers who agreed to take part in the trial and clinicians who have supported participant enrolment into the trial. This study was supported by the National Institute for Health Research (NIHR), the NIHR MindTech MedTech Co-operative, the NIHR Nottingham Biomedical Research Centre and the Clinical Research Network-Mental Health. MBi is part funded by NIHR CLAHRC West Midlands. We are grateful to the Psychosis Research Unit (PRU) Service User Reference Group (SURG) for their consultation regarding the design of the study and contribution to the developments of study-related materials. We are grateful to our Independent Trial Steering Committee and Independent Data Monitoring Committee for providing oversight of the trial. Funding MAPS was funded by the NIHR HTA programme (project number 15/31/04) and the final report will be published in Health Technology Assessment. Visit the HTA programme website for further project information. The Sponsor is Greater Manchester Mental Health NHS Foundation Trust, email R&D@gmmh.nhs.uk. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health. Authors’ contributions MP made substantial contribution to the development of the trial protocol and to the overall management of the trial and data management, and wrote the first draft of the manuscript. AL, AY, CH, DFo, DFr, DS, EL, LD, PF, SP, MBi, MBr and REB contributed to the application for funding, made substantial contribution to the design of the trial and protocol and critically read the manuscript. EJ contributed to the writing of the manuscript. GM made substantial contribution to the design of the trial, the protocol and the statistical analysis plan and critically read the manuscript. JN, RE contributed to the application for funding, made substantial contribution to the design of the trial, the protocol and the statistical analysis plan and critically read the manuscript. PH made substantial contribution to the design of the trial and protocol and critically read the manuscript. JS made a substantial contribution to the family intervention component of the protocol, provided FI supervision to therapists on the trial and contributed to the writing of the manuscript. JH made substantial contribution to the statistical analysis plan and critically read the manuscript. APM planned the study, contributed to the application for funding, made substantial contribution to the design of the trial protocol and the statistical analysis plan, managed the stud, and critically read the manuscript. All authors read and approved the final manuscript.

PY - 2019/7/4

Y1 - 2019/7/4

N2 - 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.

AB - 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.

KW - CBT

KW - antipsychotics

KW - psychosis

KW - Adolescent psychosis

KW - Family intervention

KW - Randomised controlled trial

KW - Schizophrenia

KW - First-episode psychosis

KW - Cognitive behavioural therapy

KW - Psychological intervention

KW - Antipsychotic medication

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DO - 10.1186/s13063-019-3506-1

M3 - Article

VL - 20

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 395

ER -