Psychological intervention, antipsychotic medication or a combined treatment for adolescents with a first episode of psychosis: the MAPS feasibility three-arm RCT
Background: When psychosis emerges in young people there is a risk of poorer outcomes, and access to evidence-based treatments is paramount. The current evidence base is limited. Antipsychotic medications show only a small benefit over placebo, but young people experience more side effects than adul...
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NIHR Journals Library
2021-01-01
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Series: | Health Technology Assessment |
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Online Access: | https://doi.org/10.3310/hta25040 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Anthony P Morrison Melissa Pyle Rory Byrne Matthew Broome Daniel Freeman Louise Johns Anthony James Nusrat Husain Richard Whale Graeme MacLennan John Norrie Jemma Hudson Sarah Peters Linda Davies Samantha Bowe Jo Smith David Shiers Emmeline Joyce Wendy Jones Chris Hollis Daniel Maughan |
spellingShingle |
Anthony P Morrison Melissa Pyle Rory Byrne Matthew Broome Daniel Freeman Louise Johns Anthony James Nusrat Husain Richard Whale Graeme MacLennan John Norrie Jemma Hudson Sarah Peters Linda Davies Samantha Bowe Jo Smith David Shiers Emmeline Joyce Wendy Jones Chris Hollis Daniel Maughan Psychological intervention, antipsychotic medication or a combined treatment for adolescents with a first episode of psychosis: the MAPS feasibility three-arm RCT Health Technology Assessment adolescent antipsychotic agents cognitive therapy feasibility studies psychotic disorders schizophrenia |
author_facet |
Anthony P Morrison Melissa Pyle Rory Byrne Matthew Broome Daniel Freeman Louise Johns Anthony James Nusrat Husain Richard Whale Graeme MacLennan John Norrie Jemma Hudson Sarah Peters Linda Davies Samantha Bowe Jo Smith David Shiers Emmeline Joyce Wendy Jones Chris Hollis Daniel Maughan |
author_sort |
Anthony P Morrison |
title |
Psychological intervention, antipsychotic medication or a combined treatment for adolescents with a first episode of psychosis: the MAPS feasibility three-arm RCT |
title_short |
Psychological intervention, antipsychotic medication or a combined treatment for adolescents with a first episode of psychosis: the MAPS feasibility three-arm RCT |
title_full |
Psychological intervention, antipsychotic medication or a combined treatment for adolescents with a first episode of psychosis: the MAPS feasibility three-arm RCT |
title_fullStr |
Psychological intervention, antipsychotic medication or a combined treatment for adolescents with a first episode of psychosis: the MAPS feasibility three-arm RCT |
title_full_unstemmed |
Psychological intervention, antipsychotic medication or a combined treatment for adolescents with a first episode of psychosis: the MAPS feasibility three-arm RCT |
title_sort |
psychological intervention, antipsychotic medication or a combined treatment for adolescents with a first episode of psychosis: the maps feasibility three-arm rct |
publisher |
NIHR Journals Library |
series |
Health Technology Assessment |
issn |
1366-5278 2046-4924 |
publishDate |
2021-01-01 |
description |
Background: When psychosis emerges in young people there is a risk of poorer outcomes, and access to evidence-based treatments is paramount. The current evidence base is limited. Antipsychotic medications show only a small benefit over placebo, but young people experience more side effects than adults. There is sparse evidence for psychological intervention. Research is needed to determine the clinical effectiveness and cost-effectiveness of psychological intervention versus antipsychotic medication versus a combined treatment for adolescents with psychosis. Objectives: The objective of Managing Adolescent first-episode Psychosis: a feasibility Study (MAPS) was to determine the feasibility of conducting a definitive trial to answer the question of clinical effectiveness and cost-effectiveness of these three treatment options. Design: This was a prospective, randomised, open-blinded, evaluation feasibility trial with a single blind. Participants were allocated 1 : 1 : 1 to receive antipsychotic medication, psychological intervention or a combination of both. A thematic qualitative study explored the acceptability and feasibility of the trial. Setting: Early intervention in psychosis services and child and adolescent mental health services in Manchester, Oxford, Lancashire, Sussex, Birmingham, Norfolk and Suffolk, and Northumberland, Tyne and Wear. Participants: People aged 14–18 years experiencing a first episode of psychosis either with an International Classification of Diseases, Tenth Revision, schizophrenia spectrum diagnosis or meeting the entry criteria for early intervention in psychosis who had not received antipsychotic medication or psychological intervention within the last 3 months. Interventions: Psychological intervention involved up to 26 hours of cognitive–behavioural therapy and six family intervention sessions over 6 months, with up to four booster sessions. Antipsychotic medication was prescribed by the participant’s psychiatrist in line with usual practice. Combined treatment was a combination of psychological intervention and antipsychotic medication. Main outcome measures: The primary outcome was feasibility (recruitment, treatment adherence and retention). We used a three-stage progression criterion to determine feasibility. Secondary outcomes were psychosis symptoms, recovery, anxiety and depression, social and educational/occupational functioning, drug and alcohol use, health economics, adverse/metabolic side effects and adverse/serious adverse events. Results: We recruited 61 out of 90 (67.8%; amber zone) potential participants (psychological intervention, n = 18; antipsychotic medication, n = 22; combined treatment, n = 21). Retention to follow-up was 51 out of 61 participants (83.6%; green zone). In the psychological intervention arm and the combined treatment arm, 32 out of 39 (82.1%) participants received six or more sessions of cognitive–behavioural therapy (green zone). In the combined treatment arm and the antipsychotic medication arm, 28 out of 43 (65.1%) participants received antipsychotic medication for 6 consecutive weeks (amber zone). There were no serious adverse events related to the trial and one related adverse event. Overall, the number of completed secondary outcome measures, including health economics, was small. Limitations: Medication adherence was determined by clinician report, which can be biased. The response to secondary outcomes was low, including health economics. The small sample size obtained means that the study lacked statistical power and there will be considerable uncertainty regarding estimates of treatment effects. Conclusions: It is feasible to conduct a trial comparing psychological intervention with antipsychotic medication and a combination treatment in young people with psychosis with some adaptations to the design, including adaptations to collection of health economic data to determine cost-effectiveness. Future work: An adequately powered definitive trial is required to provide robust evidence. Trial registration: Current Controlled Trials ISRCTN80567433. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 4. See the NIHR Journals Library website for further project information. |
topic |
adolescent antipsychotic agents cognitive therapy feasibility studies psychotic disorders schizophrenia |
url |
https://doi.org/10.3310/hta25040 |
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doaj-abcc4d9aeaa74caf9fbda71829f5b9e52021-01-26T09:52:33ZengNIHR Journals LibraryHealth Technology Assessment1366-52782046-49242021-01-0125410.3310/hta2504015/31/04Psychological intervention, antipsychotic medication or a combined treatment for adolescents with a first episode of psychosis: the MAPS feasibility three-arm RCTAnthony P Morrison0Melissa Pyle1Rory Byrne2Matthew Broome3Daniel Freeman4Louise Johns5Anthony James6Nusrat Husain7Richard Whale8Graeme MacLennan9John Norrie10Jemma Hudson11Sarah Peters12Linda Davies13Samantha Bowe14Jo Smith15David Shiers16Emmeline Joyce17Wendy Jones18Chris Hollis19Daniel Maughan20Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UKPsychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UKPsychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UKInstitute for Mental Health, School of Psychology, University of Birmingham, Birmingham, UKDepartment of Psychiatry, Medical Sciences Division, University of Oxford, Oxford, UKDepartment of Psychiatry, Medical Sciences Division, University of Oxford, Oxford, UKDepartment of Psychiatry, Medical Sciences Division, University of Oxford, Oxford, UKDivision of Psychology and Mental Health, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UKBrighton and Sussex Medical School, University of Sussex, Brighton, UKHealth Services Research Unit, University of Aberdeen, Aberdeen, UKClinical Trials Unit, University of Edinburgh, Edinburgh, UKHealth Services Research Unit, University of Aberdeen, Aberdeen, UKDivision of Psychology and Mental Health, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UKDivision of Psychology and Mental Health, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UKPsychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UKSchool of Allied Health and Community, University of Worcester, Worcester, UKPsychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UKPsychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UKPsychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UKNational Institute for Health Research MindTech MedTech Co-operative, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, UKWarneford Hospital, Oxford Health NHS Foundation Trust, Oxford, UKBackground: When psychosis emerges in young people there is a risk of poorer outcomes, and access to evidence-based treatments is paramount. The current evidence base is limited. Antipsychotic medications show only a small benefit over placebo, but young people experience more side effects than adults. There is sparse evidence for psychological intervention. Research is needed to determine the clinical effectiveness and cost-effectiveness of psychological intervention versus antipsychotic medication versus a combined treatment for adolescents with psychosis. Objectives: The objective of Managing Adolescent first-episode Psychosis: a feasibility Study (MAPS) was to determine the feasibility of conducting a definitive trial to answer the question of clinical effectiveness and cost-effectiveness of these three treatment options. Design: This was a prospective, randomised, open-blinded, evaluation feasibility trial with a single blind. Participants were allocated 1 : 1 : 1 to receive antipsychotic medication, psychological intervention or a combination of both. A thematic qualitative study explored the acceptability and feasibility of the trial. Setting: Early intervention in psychosis services and child and adolescent mental health services in Manchester, Oxford, Lancashire, Sussex, Birmingham, Norfolk and Suffolk, and Northumberland, Tyne and Wear. Participants: People aged 14–18 years experiencing a first episode of psychosis either with an International Classification of Diseases, Tenth Revision, schizophrenia spectrum diagnosis or meeting the entry criteria for early intervention in psychosis who had not received antipsychotic medication or psychological intervention within the last 3 months. Interventions: Psychological intervention involved up to 26 hours of cognitive–behavioural therapy and six family intervention sessions over 6 months, with up to four booster sessions. Antipsychotic medication was prescribed by the participant’s psychiatrist in line with usual practice. Combined treatment was a combination of psychological intervention and antipsychotic medication. Main outcome measures: The primary outcome was feasibility (recruitment, treatment adherence and retention). We used a three-stage progression criterion to determine feasibility. Secondary outcomes were psychosis symptoms, recovery, anxiety and depression, social and educational/occupational functioning, drug and alcohol use, health economics, adverse/metabolic side effects and adverse/serious adverse events. Results: We recruited 61 out of 90 (67.8%; amber zone) potential participants (psychological intervention, n = 18; antipsychotic medication, n = 22; combined treatment, n = 21). Retention to follow-up was 51 out of 61 participants (83.6%; green zone). In the psychological intervention arm and the combined treatment arm, 32 out of 39 (82.1%) participants received six or more sessions of cognitive–behavioural therapy (green zone). In the combined treatment arm and the antipsychotic medication arm, 28 out of 43 (65.1%) participants received antipsychotic medication for 6 consecutive weeks (amber zone). There were no serious adverse events related to the trial and one related adverse event. Overall, the number of completed secondary outcome measures, including health economics, was small. Limitations: Medication adherence was determined by clinician report, which can be biased. The response to secondary outcomes was low, including health economics. The small sample size obtained means that the study lacked statistical power and there will be considerable uncertainty regarding estimates of treatment effects. Conclusions: It is feasible to conduct a trial comparing psychological intervention with antipsychotic medication and a combination treatment in young people with psychosis with some adaptations to the design, including adaptations to collection of health economic data to determine cost-effectiveness. Future work: An adequately powered definitive trial is required to provide robust evidence. Trial registration: Current Controlled Trials ISRCTN80567433. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 4. See the NIHR Journals Library website for further project information.https://doi.org/10.3310/hta25040adolescentantipsychotic agentscognitive therapyfeasibility studiespsychotic disordersschizophrenia |