Managing unusual sensory experiences for people with an at-risk mental state for psychosis

Managing Unusual Sensory Experiences (MUSE): a feasibility trial of a targeted, psychoeducation toolkit for distressing hallucinations for people with an At-Risk Mental State (ARMS) for psychosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN58558617

Enrollment

Registered

2023-05-09

Start date

2023-04-14

Completion date

Unknown

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reducing distress from unusual sensory experiences in people with an At Risk Mental State for psychosis Mental and Behavioural Disorders

Interventions

The intervention is the Managing Unusual Sensory Experiences (MUSE) treatment. This is a psychological intervention that focuses on the causes of voices and visions. The control arm involves time-matc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. In contact with an ARMS service or accepted on an ARMS pathway by Early Intervention in Psychosis (EIP) services 2. Aged 14–35 years 3. Hallucinations/unusual sensory experiences scoring at least 3 on the Perceptual Abnormalities Subscale of the CAARMS 4. Hallucinations considered by the patient to be a key target problem 5. Judged to have been clinically stable for the preceding 2 weeks

Exclusion criteria

Exclusion criteria: 1. Intellectual disability or severe cognitive dysfunction affecting ability to engage with research materials 2. Lacking capacity to give informed consent

Design outcomes

Primary

Measure	Time frame
As this is a feasibility trial, feasibility outcomes for the delivery of a large-scale randomised controlled trial are of key importance. The primary outcome of this feasibility trial is the ability of the trial to recruit 88 participants, who reflect the diversity within the region, meet study inclusion criteria over the 9-month recruitment period, and complete assessment measures collected at baseline, post-intervention (12 weeks post-randomisation) and follow-up (20 weeks post-randomisation), until all participants complete the follow-up assessment or withdraw. The researchers will use a traffic light system to inform progressions criteria (above 80%: green; 60–79%: amber; below 60%: red) and will use a consort diagram to plot progression through the trial and will review at end of the trial data collection (final assessment of final participant). 1. Referral rate. The researchers will check the percentage of potentially eligible clients who are referred. The date used to inform recruitment rate suggested quite different rates of eligibility across the two sites (65% in TEWV and 95% in CNTW). 2. Recruitment rate. The researchers calculated that they should be able to recruit 9.8 pcm. They will monitor across the study and green would be achieving 80%, therefore 7.85 pcm. 3. Reasons for declining participation. The non-consent group will be sensitively asked to share reasons for non-participation via the NIHR Participant Research Experience ‘Okay to say No’ (anonymous) questionnaire (https://myresearchexperience.com/), which asks an open question about the reasons for deciding not to take part, along with basic demographic information (age and ethnicity). This will happen at the point the potential participant declines to participate. 4. Allocation compliance rate and attrition rate. We will monitor this through our CONSORT diagram and review at the end of the trial, using our traffic light system. 5. Appropriateness and integrity of treatment protocols. Therap	—

Measure

Time frame

As this is a feasibility trial, feasibility outcomes for the delivery of a large-scale randomised controlled trial are of key importance. The primary outcome of this feasibility trial is the ability of the trial to recruit 88 participants, who reflect the diversity within the region, meet study inclusion criteria over the 9-month recruitment period, and complete assessment measures collected at baseline, post-intervention (12 weeks post-randomisation) and follow-up (20 weeks post-randomisation), until all participants complete the follow-up assessment or withdraw. The researchers will use a traffic light system to inform progressions criteria (above 80%: green; 60–79%: amber; below 60%: red) and will use a consort diagram to plot progression through the trial and will review at end of the trial data collection (final assessment of final participant). 1. Referral rate. The researchers will check the percentage of potentially eligible clients who are referred. The date used to inform recruitment rate suggested quite different rates of eligibility across the two sites (65% in TEWV and 95% in CNTW). 2. Recruitment rate. The researchers calculated that they should be able to recruit 9.8 pcm. They will monitor across the study and green would be achieving 80%, therefore 7.85 pcm. 3. Reasons for declining participation. The non-consent group will be sensitively asked to share reasons for non-participation via the NIHR Participant Research Experience ‘Okay to say No’ (anonymous) questionnaire (https://myresearchexperience.com/), which asks an open question about the reasons for deciding not to take part, along with basic demographic information (age and ethnicity). This will happen at the point the potential participant declines to participate. 4. Allocation compliance rate and attrition rate. We will monitor this through our CONSORT diagram and review at the end of the trial, using our traffic light system. 5. Appropriateness and integrity of treatment protocols. Therap

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Secondary

Measure	Time frame
The treatment delivered in this intervention aims to improve functioning and reduce the distress associated with hallucinations. Accordingly, candidate primary outcome measures that will be investigated for suitability for future trials are global functioning, as measured on the SOFAS, and hallucinations measured using the PSYRATS hallucination scale, with attention to subscales of interest: distress and attribution. The effect of the interventions on outcomes will be estimated from the change from baseline as well as changes in the mean scores in each trial arm. The feasibility of measuring caseness and caseness change, or clinically meaningful levels of response will be explored. 1. Functioning assessed using the Social and Occupational Functional Assessment Scale (SOFAS) 2. Mental State assessed using the Psychotic Symptom Rating Scale (PSYRATS) hallucinations total 3. Hallucinations assessed using the Psychotic Symptom Rating Scale (PSYRATS) distress 4. Attribution assessed using the Psychotic Symptom Rating Scale (PSYRATS) attribution These measures are collected at three timepoints; baseline, post-treatment (12 weeks post-baseline), follow-up (20 weeks post-baseline).	—

Measure

Time frame

The treatment delivered in this intervention aims to improve functioning and reduce the distress associated with hallucinations. Accordingly, candidate primary outcome measures that will be investigated for suitability for future trials are global functioning, as measured on the SOFAS, and hallucinations measured using the PSYRATS hallucination scale, with attention to subscales of interest: distress and attribution. The effect of the interventions on outcomes will be estimated from the change from baseline as well as changes in the mean scores in each trial arm. The feasibility of measuring caseness and caseness change, or clinically meaningful levels of response will be explored. 1. Functioning assessed using the Social and Occupational Functional Assessment Scale (SOFAS) 2. Mental State assessed using the Psychotic Symptom Rating Scale (PSYRATS) hallucinations total 3. Hallucinations assessed using the Psychotic Symptom Rating Scale (PSYRATS) distress 4. Attribution assessed using the Psychotic Symptom Rating Scale (PSYRATS) attribution These measures are collected at three timepoints; baseline, post-treatment (12 weeks post-baseline), follow-up (20 weeks post-baseline).

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026