Managing Unusual Sensory Experiences (MUSE): A feasibility trial of a targeted,psycho-education toolkit for distressing hallucinations, in people with a firstepisode of psychosis.

Background Hallucinations (hearing or seeing things that others do not) are a common feature of psychosis, causing significant distress and disability.

The National Institute for Health & Care Excellence (NICE) recommends that all individuals with psychosis be offered Cognitive Behaviour Therapy for psychosis (CBTp). However, in practice access is often limited owing to a lack of CBTp-trained staff.

One solution is to develop shorter, targeted treatments that use CBTp-informed techniques to focus on specific symptoms.

This has produced promising results for other symptoms of psychosis, such as delusions (i.e. unusual beliefs), but there has been less research on hallucinations.

Our toolkit, MUSE, (Managing Unusual Sensory Experiences) explains why people have hallucinations and helps the person to develop and use coping strategies to reduce distress. The MUSE intervention focuses only on hallucinations, so treatment is short (4-6, one hour weekly sessions).

It can be used on tablets, laptops or desktop computers (ensuring its accessibility to NHS staff) and provides information about hallucinations in a user-friendly and engaging way, including use of audio, video, and animated content.

Crucially, it is designed for use not just by trained CBT therapists, but also non-specialist staff like Community Psychiatric Nurses (CPNs).

Aims The long-term aim of this research is to increase the number of psychosis patients who have access to an intervention to reduce the distress of hallucinations. Prior to that effectiveness and cost-effectiveness need to be established.

As a step towards that the proposed study aims to establish if it is feasible to conduct a future clinical- and cost-effectiveness study. It addresses the following questions. .

Research questions Is it feasible for CPNs to be trained in MUSE and to deliver it to psychosis patients within NHS Mental Health Services? Is MUSE – delivered by CPNs – acceptable to service-users and staff?

Is it feasible to evaluate the clinical and cost effectiveness of the MUSE– thus informing the design of a definitive trial?

Plan of Investigation The proposed study is a two-arm feasibility RCT comparing MUSE and treatment as usual (TAU) (n=40) to TAU alone (n=40), recruiting across two sites, using 1:1 allocation and blind assessments before and after treatment, and at 3-months follow up. 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. These data will determine if it is feasible to deliver MUSE and evaluate it in the target population.

If an evaluation is possible, the results from the current study will inform the parameters and stop/go/refine criteria for a future definitive trial (which would include an internal pilot and fully powered randomised controlled trial).

Potential benefits to patients and the NHS If MUSE is found to be clinically and cost-effective when delivered by CPNs in a definitive multisite study, this intervention could considerably increase access to tailored treatment for psychosis patients distressed by hallucinations.