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
UR - http://www.scopus.com/inward/record.url?scp=85068571686&partnerID=8YFLogxK
UR - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3506-1
UR - http://www.mendeley.com/research/study-protocol-randomised-controlled-trial-cbt-vs-antipsychotics-vs-both-1418yearolds-managing-adole
U2 - 10.1186/s13063-019-3506-1
DO - 10.1186/s13063-019-3506-1
M3 - Article
C2 - 31272477
VL - 20
JO - Trials
JF - Trials
SN - 1745-6215
M1 - 395
ER -
