Psychological intervention, antipsychotic medication or a combined treatment for adolescents with a first episode of psychosis: the MAPS feasibility three-arm RCT

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. 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.

Adapting cognitive behavioural therapy for adolescents with psychosis: insights from the Managing Adolescent first episode in psychosis study (MAPS)

“…Outdoor therapy (with consideration given to confidentiality) can enable greater shared ownership of the therapy space and relationship (Cooley et al, 2020 ). Over a third of MAPS therapists suggested a longer therapy window would help build engagement and accommodate periods of disengagement, academic examinations, and the impact of risk on therapy (Morrison et al, 2021 ).…”

“…Notably, nearly half the YP or their families participating in MAPS were unwilling or unable to commit to optional FI sessions (Morrison et al, 2021 ). This highlights the need for a flexible approach to involving others in terms of length, location, type of delivery, and ensuring YP hold some autonomy in their treatment decisions.…”

“…This may lead to modification and motivate action towards identified goals. MAPS trial therapists nearly always developed a shared maintenance formulation by session 3, with around half developing a comprehensive shared longitudinal formulation by session 26 (Morrison et al, 2021 ).…”

“…There was a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups. No findings suggested that psychological interventions in the absence of antipsychotic medication were detrimental (See, Morrison et al, 2020 , 2021 for detailed findings).…”

“…This paper aims to disseminate clinical practice learnings to help tailor CBTp to meet the developmental needs of adolescence with psychosis. Learnings are drawn from a group of highly specialist trial therapists and expert supervisors delivering CBT to adolescents (aged 14–18 years) with first-episode psychosis as part of the Managing Adolescent first-episode Psychosis: a feasibility Study (MAPS) randomised clinical treatment trial conducted in England (Morrison et al, 2021 , 2020 ), 1 supported by findings from nested qualitative interviews investigating treatment views of YP and family members who received this psychological treatment (For further information, see Byrne et al, 2020 ).…”