Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.
Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
Health Technol Assess. 2021 Jan;25(4):1-124. doi: 10.3310/hta25040.
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.
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.
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.
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.
People aged 14-18 years experiencing a first episode of psychosis either with an , 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.
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.
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.
We recruited 61 out of 90 (67.8%; amber zone) potential participants (psychological intervention, = 18; antipsychotic medication, = 22; combined treatment, = 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.
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.
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.
An adequately powered definitive trial is required to provide robust evidence.
Current Controlled Trials ISRCTN80567433.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 4. See the NIHR Journals Library website for further project information.
当年轻人出现精神病时，其结果可能会更差，因此获得循证治疗至关重要。目前的证据基础有限。抗精神病药物的疗效仅比安慰剂略好，但年轻人比成年人更容易出现副作用。针对心理干预的证据也很少。需要研究确定心理干预与抗精神病药物治疗或联合治疗青少年精神病的临床效果和成本效益。
青少年首发精神病管理研究（MAPS）的目的是确定开展一项确定性试验的可行性，以回答这三种治疗方案的临床效果和成本效益问题。
这是一项前瞻性、随机、开放盲法、评估可行性的试验，采用单盲法。参与者按 1:1:1 比例随机分配接受抗精神病药物、心理干预或两者联合治疗。一项主题定性研究探索了试验的可接受性和可行性。
曼彻斯特、牛津、兰开夏、苏塞克斯、伯明翰、诺福克和萨福克以及诺森伯兰、泰恩和威尔的早期精神病干预服务和儿童及青少年心理健康服务机构。
年龄在 14 至 18 岁之间的首次出现精神病的个体，符合精神分裂症谱系障碍的第十版诊断标准或符合早期精神病干预的纳入标准，并且在过去 3 个月内未接受过抗精神病药物或心理干预。
心理干预包括最多 26 小时的认知行为疗法和 6 次家庭干预疗程，最多可进行 4 次强化疗程。抗精神病药物由参与者的精神病医生根据常规治疗方案开具。联合治疗是心理干预和抗精神病药物治疗的结合。
主要结局是可行性（招募、治疗依从性和保留率）。我们使用三阶段进展标准来确定可行性。次要结局指标是精神病症状、康复、焦虑和抑郁、社会和教育/职业功能、药物和酒精使用、健康经济学、不良/代谢副作用和不良/严重不良事件。
我们从 90 名潜在参与者中招募了 61 名（67.8%；琥珀区）（心理干预组，n=18；抗精神病药物组，n=22；联合治疗组，n=21）。61 名参与者中有 51 名（83.6%；绿区）完成了随访。在心理干预组和联合治疗组中，39 名参与者中有 32 名（82.1%）接受了六次或更多次认知行为疗法疗程（绿区）。在联合治疗组和抗精神病药物组中，43 名参与者中有 28 名（65.1%）接受了连续六周的抗精神病药物治疗（琥珀区）。试验中没有与治疗相关的严重不良事件，只有 1 例与治疗相关的不良事件。总的来说，包括健康经济学在内的次要结局指标的完成数量较少。
药物依从性是由临床医生报告确定的，可能存在偏差。对次要结局的反应较低，包括健康经济学。获得的样本量较小，意味着研究缺乏统计学效力，对于治疗效果的估计存在相当大的不确定性。
在年轻人精神病患者中，比较心理干预与抗精神病药物治疗和联合治疗是可行的，需要对设计进行一些调整，包括调整健康经济学数据的收集以确定成本效益。
需要进行一项充分有力的确定性试验，以提供可靠的证据。
当前对照试验 ISRCTN80567433。
本项目由英国国家卫生研究院（NIHR）健康技术评估计划资助，将在《Health Technology Assessment》杂志 25 卷 4 期全文发表。有关该项目的更多信息，请访问 NIHR 期刊库网站。
