DOI: 10.15128/r2nv9352901
title: MUSE ARMS Feasibility Trial [dataset]

description: Objectives To conduct a feasibility study (NIHR RfPB 204125) on a new, tablet-delivered treatment for unusual sensory experiences in service-users with an At Risk Mental State for psychosis. Design A mixed-method feasibility trial was conducted, employing a prospective, randomised, open-label, observer-blinded endpoint design with MUSE+TAU compared to TAU alone, with assessments at pre- and post-treatment and a follow-up 8 weeks after treatment finished. Methods Eligible participants were contacted before starting treatment and offered the chance to participate. Assessments were conducted before and after the treatment, which typically was completed in 4-6 sessions by an accredited CBT therapist. Primary outcome measures were the PSYRATS and SOFAS. A structured interview was used to collect qualitative feedback. Results All progression criteria were met, with the study recruiting at 98% of the target rate (93 participants recruited), achieving 82% of therapy engagement, an assessment retention of 79%, 100% on therapy fidelity and no related Severe Adverse Events. Qualitative feedback suggested that the treatment was acceptable to service-users and therapists. Full trial results will be reported in the Trial Outcomes Paper (Dodgson et al. In Preparation). Conclusions The new treatment targeting subtypes of auditory and visual hallucinations was acceptable to service-users and staff and all progression criteria were met.
description: MUSE ARMS Feasibility RCT: A feasibility trial employing a prospective randomised, open-label, observer blinded, endpoint design assessing a targeted, computer/web based guided self-help psycho-education toolkit for distressing hallucinations (MUSE) +treatment as usual (TAU) compared to a time matched TAU, which includes emotional support, psychoeducation and stress management, for managing hallucinations, improving functioning and reducing distress in people with an At Risk Mental State (ARMS) for psychosis in UK secondary care mental health services. Trial Design A mixed-method feasibility trial employing a prospective, randomised, open-label, observer blinded endpoint design with MUSE+TAU compared to time matched TAU, with assessments at pre- and post-treatment and at five-month follow-up. Trial Participants Patients aged 14-35 years with an At Risk Mental State (ARMS) for developing psychosis Planned Sample Size 88 participants recruited from At Risk Mental State NHS services and NHS Early Intervention in Psychosis serving ARMS patients in the UK Actual Sample Size 93 participants enrolled into the trial (randomised) Treatment duration 6-8 sessions (6 core sessions with an option of 2 extra) Follow up duration 12 weeks (primary), 20 weeks (secondary) Planned Trial Period 1st January 2023 – 30th September 2024 Objectives Outcome Measures Primary To conduct a randomised controlled feasibility trial to address key uncertainties of delivering MUSE in an ARMS population and identify preliminary effect of MUSE+TAU verses time matched TAU on general functioning and mental state in ARMS patients (i) Feasibility outcomes, including qualitative interviews (ii) Functioning (SOFAS) (iii) Hallucinations (PSYRATS hallucination total) (iv) Hallucinations target problem (PSYRATS distress & PSYRATS attribution) Post-treatment endpoint as primary endpoint Secondary outcomes 1) to explore indicators of mental health treatment outcomes (and moderators) 2) to test the feasibility of investigating which psychological mechanisms are influenced by MUSE and contribute to its clinical effect 3) to collect routine data to enable later studies to examine which features of MUSE are most relevant to the prevention of development of psychosis 1) CAARMS-PA Subscale, GAD-7, PHQ-9, ReQoL-20, MMHS, ISI, ITQ/ITQ-CA 2) Self-report validated questionnaires and computerised cognitive tasks pertaining to participant experience subtype: Inner speech/Memory/ Hypervigilance/Visual 3) Clinical records documentation Qualitative interviews will also be undertaken with participants post-treatment to explore feasibility issues and understand subtypes/mechanisms Novel Intervention Managing Unusual Sensory Experiences (MUSE): A novel computer based guided self-help toolkit incorporating 8 modules for understanding and coping with hallucinations. Comparison Intervention Treatment as usual: Primarily focusing on needs based emotional support, psychoeducation, normalisation, stress management and other multi-disciplinary support.