MUSE ARMS Feasibility Trial [dataset]

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.