Managing Unusual Sensory Experiences in People with First-Episode Psychosis (MUSE FEP): a study protocol for a single-blind parallel-group randomised controlled feasibility trial.

Hallucinations (hearing or seeing things that others do not) are a common feature of psychosis, causing significant distress and disability. Existing treatments such as cognitive-behavioural therapy for psychosis (CBTp) have modest benefits, and there is a lack of CBTp-trained staff. Shorter, targeted treatments that focus on specific symptoms delivered by a non-specialist workforce could substantially increase access to treatment.Managing Unusual Sensory Experiences (MUSE) explains why people have hallucinations and helps the person to develop and use coping strategies to reduce distress. MUSE focuses only on hallucinations, and treatment is short (four to six, 1-hour sessions per week). It is a digital intervention, run on National Health Service (NHS) laptops, which provides information about hallucinations in an engaging way, using audio, video and animated content. Crucially, it is designed for use by non-specialist staff like community psychiatric nurses. The study is a two-arm feasibility randomised controlled trial comparing MUSE and treatment as usual (TAU) (n=40) to TAU alone (n=40), recruiting across two NHS Trusts, using 1:1 allocation and blind assessments before and after treatment (2 months) and at follow-up (3 months). Quantitative information on recruitment rates, adherence and completion of outcome assessments will be collected. Qualitative interviews will capture service users' experience of therapy and clinicians' experiences of the training and supervision in MUSE. Clinicians will also be asked about factors affecting uptake, adherence and facilitators/barriers to implementation. Analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the training, intervention and trial procedures. The trial has received NHS Ethical and Health Research Authority approval. Findings will be disseminated directly to participants and services, as well as through peer-reviewed publications and conference presentations. ISRCTN16793301.

Dudley R ，Dodgson G ，Common S ，O'Grady L ，Watson F ，Gibbs C ，Arnott B ，Fernyhough C ，Alderson-Day B ，Ogundimu E ，Kharatikoopaei E ，Patton V ，Aynsworth C ... -  《BMJ Open》

Effects of a novel, brief psychological therapy (Managing Unusual Sensory Experiences) for hallucinations in first episode psychosis (MUSE FEP): Findings from an exploratory randomised controlled trial.

Hallucinations are a common feature of psychosis, yet access to effective psychological treatment is limited. The Managing Unusual Sensory Experiences for First-Episode-Psychosis (MUSE-FEP) trial aimed to establish the feasibility and acceptability of a brief, hallucination-specific, digitally provided treatment, delivered by a non-specialist workforce for people with psychosis. MUSE uses psychoeducation about the causal mechanisms of hallucinations and tailored interventions to help a person understand and manage their experiences. We undertook a two-site, single-blind (rater) Randomised Controlled Trial and recruited 82 participants who were allocated 1:1 to MUSE and treatment as usual (TAU) (n = 40) or TAU alone (n = 42). Participants completed assessments before and after treatment (2 months), and at follow up (3-4 months). Information on recruitment rates, adherence, and completion of outcome assessments was collected. Analyses focussed on feasibility outcomes and initial estimates of intervention effects to inform a future trial. The trial is registered with the ISRCTN registry 16793301. Criteria for the feasibility of trial methodology and intervention delivery were met. The trial exceeded the recruitment target, had high retention rates (87.8%) at end of treatment, and at follow up (86.6%), with good acceptability of treatment. There were 3 serious adverse events in the therapy group, and 5 in the TAU group. Improvements were evident in both groups at the end of treatment and follow up, with a particular benefit in perceived recovery in the MUSE group. We showed it was feasible to increase access to psychological intervention but a definitive trial requires further changes to the trial design or treatment.

Dudley R ，Dodgson G ，Common S ，Ogundimu E ，Liley J ，O'Grady L ，Watson F ，Gibbs C ，Arnott B ，Fernyhough C ，Alderson-Day B ，Aynsworth C ... -  《-》

Use of a targeted, computer/web-based guided self-help psychoeducation toolkit for distressing hallucinations (MUSE) in people with an at-risk mental state for psychosis: protocol for a randomised controlled feasibility trial.

Individuals who access at-risk mental state (ARMS) services often have unusual sensory experiences and levels of distress that lead them to seek help. The Managing Unusual Sensory Experiences (MUSE) treatment is a brief symptom targeted intervention that draws on psychological explanations to help account for unusual experiences. Practitioners use formulation and behavioural experiments to support individuals to make sense of their experiences and enhance coping strategies. The primary objective of this feasibility trial is to resolve key uncertainties before a definitive trial and inform parameters of a future fully powered trial. 88 participants aged 14-35 accepted into ARMS services, experiencing hallucinations/unusual sensory experiences which are considered by the patient to be a key target problem will be recruited from UK National Health Service (NHS) sites and randomised using 1:1 allocation (stratified by site, gender, and age) to either 6-8 sessions of MUSE or time-matched treatment as usual. Participants and therapists will be unblinded, research assessors are blinded. Blinded assessment will occur at baseline, 12 weeks and 20 weeks postrandomisation. Data will be reported in line with Consolidated Standards of Reporting Trials. Primary trial outcomes are feasibility outcomes, primary participant outcomes are functioning and hallucinations. Additional analysis will investigate potential psychological mechanisms and secondary mental well-being outcomes. Trial progression criteria follows signal of efficacy and uses an analytical framework with a traffic-light system to determine viability of a future trial. Subsequent analysis of the NHS England Mental Health Services Data Set 3 years postrandomisation will assess long-term transition to psychosis. This trial has received Research Ethics Committee approval (Newcastle North Tyneside 1 REC; 23/NE/0032). Participants provide written informed consent; young people provide assent with parental consent. Dissemination will be to ARMS Services, participants, public and patient forums, peer-reviewed publications and conferences. ISRCTN58558617.

Hamilton J ，Arnott B ，Aynsworth C ，Barclay NA ，Birkett L ，Brandon T ，Dixon L ，Dudley R ，Einbeck J ，Gibbs C ，Kharatikoopaei E ，Simpson J ，Dodgson G ，Fernyhough C ... -  《BMJ Open》

Treating sleep problems in young people at ultra-high-risk of psychosis: study protocol for a single-blind parallel group randomised controlled feasibility trial (SleepWell).

Effective interventions, targeting key contributory causal factors, are needed to prevent the emergence of severe mental health problems in young people. Insomnia is a common clinical issue that is problematic in its own right but that also leads to the development and persistence of psychotic experiences. The implication is that treating sleep problems may prevent the onset of psychosis. We collected initial case series data with 12 young people at ultra-high-risk of psychosis. Post-intervention, there were improvements in sleep, depression and psychotic experiences. Now we test the feasibility of a randomised controlled trial, with a clinical aim to treat sleep problems and hence reduce depression, psychotic experiences, and prevent transition to psychosis. A randomised controlled feasibility trial will be conducted. Forty patients aged 14 to 25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from National Health Service (NHS) mental health services. Participants will be randomised to receive either a novel, targeted, youth-focussed sleep intervention in addition to usual care or usual care alone. Assessor-blinded assessments will be conducted at baseline, 3 months (post-intervention) and 9 months (follow-up). The eight-session psychological intervention will target the key mechanisms which disrupt sleep: circadian rhythm irregularities, low sleep pressure, and hyperarousal. To gain an in-depth understanding of participants' views on the acceptability of the intervention and study procedures, 16 participants (n=10 intervention, n=6 control) will take part in qualitative interviews. Analyses will focus on feasibility outcomes (recruitment, retention, and treatment uptake rates) and provide initial CI estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention and trial procedures. The trial has received ethical approval from the NHS Health Research Authority. Findings will be disseminated through peer-reviewed publications, conference presentations, and lay networks. ISRCTN85601537.

Waite F ，Kabir T ，Johns L ，Mollison J ，Tsiachristas A ，Petit A ，Černis E ，Maughan D ，Freeman D ... -  《BMJ Open》

The U&I study: study protocol for a feasibility randomised controlled trial of a pre-cognitive behavioural therapy digital 'informed choice' intervention to improve attitudes towards uptake and implementation of CBT for psychosis.

Greenwood K ，Alford K ，O'Leary I ，Peters E ，Hardy A ，Cavanagh K ，Field AP ，de Visser R ，Fowler D ，Davies M ，Papamichail A ，Garety P ... -  《Trials》