Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 1-124 |
| Number of pages | 124 |
| Journal | Health Technology Assessment |
| Volume | 25 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - 31 Jan 2021 |
Bibliographical note
Funding Information:The research reported in this issue of the journal was funded by the HTA programme as project number 15/31/04. The contractual start date was in March 2017. The draft report began editorial review in September 2019 and was accepted for publication in May 2020. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
Declared competing interests of authors: Anthony P Morrison reports personal fees from the provision of training workshops in cognitive–behavioural therapy for psychosis and royalties from books on the topic outside the submitted work. Melissa Pyle reports fees paid to the Psychosis Research Unit from cognitive–behavioural therapy training at Greater Manchester Mental Health NHS Foundation Trust (Manchester, UK). Rory Byrne reports personal fees from Oxford Cognitive Therapy Centre (Oxford, UK) outside the submitted work. Matthew Broom reports royalties from Oxford University Press (Oxford, UK) and personal fees from Medical Defence Union (London, UK) outside the submitted work. Daniel Freeman reports grants from the National Institute for Health Research (NIHR) and the Medical Research Council during the conduct of the study outside the submitted work. Louise Johns reports personal fees from New Harbinger Publications (Oakland, CA, USA) outside the submitted work. Nusrat Husain reports that he is the chairperson of the board of trustees of the Manchester Global Foundation (Manchester, UK), a charitable incorporated organisation registered in England and Wales; he is a past trustee of Lancashire Mind (Chorley, UK), Abaseen Foundation (Lancaster, UK) and the Pakistan Institute of Living and Learning (Karachi, Pakistan). Nusrat Husain reports that he established an independent general hospital (Remedial Centre) in Karachi, Pakistan; this is now owned and operated by his sibling, and the hospital is also attached to a pharmacy. Nusrat Husain reports that he has received an honorarium and travel grants from various pharmaceutical industries. Richard Whale reports conference attendance support from Sunovion Pharmaceuticals Inc. (Marlborough, MA, USA) and personal fees from Janssen: Pharmaceutical Companies of Johnson & Johnson (Beerse, Belgium) and from H. Lundbeck A/S (Copenhagen, Denmark) outside the submitted work. John Norrie reports membership of the following NIHR boards: cardiopulmonary resuscitation decision-making committee, Health Technology Assessment (HTA) programme Commissioning Board, HTA Commissioning Sub-board (expression of interest), HTA Funding Boards Policy Group, HTA General Board, HTA Post-Board funding teleconference, NIHR Clinical Trials Unit Standing Advisory Committee, NIHR HTA and Efficacy and Mechanism Evaluation Editorial Boards; and the Pre-exposure Prophylaxis Impact Review Panel. John Norrie also declares grants from the University of Aberdeen and the University of Edinburgh. Linda Davies reports grants from the University of Manchester during the conduct of the study. Samantha Bowe reports personal fees from private therapy practice, and personal fees from a cognitive–behavioural therapy training post at Greater Manchester Mental Health NHS Foundation Trust outside the submitted work. David Shiers reports personal fees from the National Clinical Audit of Psychosis, royalties from John Wiley & Sons, Inc. (Hoboken, NJ, USA) publication for ‘Promoting Recovery in Early Psychosis’ 2010 (ISBN 978-1-4051-4894-8) and reports membership of the current National Institute for Health and Care Excellence (NICE) guideline development group for rehabilitation in adults with complex psychosis and related severe mental health conditions. David Shiers is also a board member of the National Collaborating Centre for Mental Health (2013–present), expert adviser to the NICE centre for guidelines and clinical adviser to the National Clinical Audit of Psychosis outside the submitted work. Chris Hollis reports that he was chairperson of the NICE Guideline Development Group for Schizophrenia in Children & Young People (2011–13) and was chairperson of the NICE Psychosis and Schizophrenia in Children Evidence Update (2014–15) outside the submitted work.
Thank you to all of the participants who agreed to take part in the trial. This study was supported by the NIHR Clinical Research Network. We are grateful to the Psychosis Research Unit Service User Reference Group for their consultation regarding the design of the study and contribution to the developments of study-related materials. We are grateful to our independent Data Monitoring Committee (Emmanuelle Peters, Rod Taylor, Thomas RE Barnes and Carl Bateson) and our Trial Steering Committee (Graham Murray, Susanna Dodd, Rebecca Walwyn, Zak Howarth and Alison Brabban) for providing oversight of the trial. We are also grateful to the many researchers, trial therapists, psychiatrists and network staff who supported the study, including Amanda Larkin, Ann Steele, Elizabeth Murphy, Glynis Queenan, Jasper Palmier-Claus, Peter Haddad, Verity Smith, Samantha Hartley, Miriam Kirkham, Amy Langman, Ashley Louise-Teale, Sarah Reeve, Jessica Bird, Jo Clacey, Emmeline Goodby, Felicity Waite, Helena Laughton, Jana Safarikova, Laura Hancox, David Fowler, Renata Fiahlo, Laruen Wilcock, Catarina Sacadura, Rick Fraser, Samantha Fraser, Rachel Upthegrove, Ravneet Bhogal, Thomas Goodall, Robert Dudley, Fiona Padgett, Negar Khozoee, Laura McCartney, Sarah Maxwell, Jon Wilson, Leanne Groves, Peter Cairns, Roger Collin, Xavier Coll, Richard Emsley, Alison Yung, Ashley Liew, Eleanor Longden, Max Birchwood and Paul French.
MAPS (both main trial and qualitative studies) was funded by the NIHR HTA programme following a commissioned call (15/31/04). The call specified the interventions, population, setting, comparator, study design and important outcomes.
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ASJC Scopus subject areas
- Health Policy
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