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dc.contributor.authorHollis, Chris P.
dc.date.accessioned2019-07-17T09:12:41Z
dc.date.available2019-07-17T09:12:41Z
dc.date.issued2019
dc.identifier.citationPyle, M., Broome, M. R., Joyce, E., MacLennan, G., Norrie, J., Freeman, D., Fowler, D., Haddad, P. M., Shiers, D., Shiers, D., et al. (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, 20 (1), pp.395.en
dc.identifier.other10.1186/s13063-019-3506-1
dc.identifier.urihttp://hdl.handle.net/20.500.12904/9930
dc.description© The Author(s). 2019 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en
dc.description.abstractBACKGROUND: 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.en
dc.description.sponsorshipFunding: 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.en
dc.description.urihttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3506-1en
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dc.subjectPsychosisen
dc.subjectAntipsychotic agentsen
dc.subjectCognitive therapyen
dc.subjectCrisis interventionen
dc.subjectSchizophreniaen
dc.titleStudy 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)en
dc.typeArticleen
refterms.dateFOA2021-06-14T11:08:11Z


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