Treatment of hallucinations in people with Psychosis Mental and Behavioural Disorders
Conditions
Interventions
Managing Unusual Sensory Experiences psychoeducation (MUSE) treatment focuses on hallucinations, explains why people have them, and helps the person to develop and use coping strategies to reduce dist
Sponsors
Cumbria Northumberland Tyne and Wear NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: 1. In contact with Early Intervention in Psychosis (EIP) services 2. Have an identified CPN acting as their care coordinator 3. Meet ICD-11 criteria for schizophrenia, schizoaffective disorder, or entry criteria for an EIP service 4. Have a history of auditory hallucinations for at least four weeks 5. Aged =16 years 6. Consider their hallucinations as a main difficulty, and would like to receive an intervention specifically for hallucinations 7. Have the capacity to provide informed consent 8. Judged by their clinician to be clinically stable for the preceding 4 weeks 9. Individuals on antipsychotic treatment, and those who decline to take medication, will be included, as long as no medication changes have occurred in the previous month (i.e., having started or stopped antipsychotic medication, or a switch to or from Clozapine). Staff involved in the trial delivery will be asked to help evaluate the training, supervision, and therapy process. These are NHS staff, offering the MUSE treatment. However, the main aspect of feasibility is focussed on the trial and so these details are reported here.
Exclusion criteria
Exclusion criteria: 1. Hallucinations/psychosis with a known biological basis 2. Insufficient command of English to complete the study procedures 3. Intellectual disability, or severe cognitive dysfunction affecting the ability to provide fully informed consent to participate 4. A primary diagnosis of substance misuse/dependency 5. Currently engaged in CBTp or received CBTp in the past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establishing whether a larger, definitive trial future study can be undertaken using the following: 1. Whether the planned 3-day training equips CPNs with the skills and confidence to deliver MUSE, and whether the supervision package is sufficient and useful to support CPNs in the delivery of this toolkit, assessed through a quantitative and qualitative evaluation at the end of the training, 6 months into the study, and at end of the study 2. The acceptability of the intervention to the participants engaging in the treatment and to CPNs delivering it assessed using the following: 2.1. Participants being asked to share their views on the treatment and the toolkit at the 3-month follow-up meeting 2.2. Staff being asked to share their views on the toolkit at the end of the study 3. To inform a future trial we will collect data on the following throughout the trial: 3.1. Proportion of eligible individuals clinicians are willing to refer (referral rate) 3.2. Proportion of eligible individuals willing to participate (recruitment rate) and the proportion of participants who comply with their allocation (allocation compliance rate) 3.3. Proportion of participants who drop-out of the study (attrition rate) 3.4. Characteristics of trial participants to further clarify selection criteria 3.5. Appropriateness and integrity of treatment protocols 3.6. Randomisation procedures 3.7. Completion rate of measures 3.8. Acceptability, relevance and validity of the measures to assess clinical effectiveness and safety in a subsequent definitive trial 3.9. Appropriateness of quality of life measures, and service use data needed to undertake a future full health economic evaluation 3.10. Access to CBTp and MUSE like interventions in other EIP services in England | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be measured at baseline, after 8 weeks, and at 3 months post-randomisation (unless stated otherwise): 1. Hallucinations measured using the following: 1.1. The Psychotic Symptom Rating Scales (PSYRATS; Haddock et al., 1999), a clinician-administered semi-structured interview of hallucinations (such as amount/intensity of distress). It consists of 11 items, with 5 items being used to identify voice-related distress. Additional items to cover hallucinations in non-auditory modalities (i.e., visual, somatic, olfactory and sense of presence), and whether these are experienced at the same or different times (multi-modality), will be included. Each item is rated by the interviewer on a 5 point nominal scale (0-4). 1.2. The Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ; van Lieshout & Goldberg, 2007) - the self-report voice-impact subscale from the questionnaire will also be used. Scores on the HPSVQ correlate highly (all r>0.8) with scores on the clinician administered PSYRATS auditory hallucination (AH) scale. 2. Anxiety and Depression measured using the Depression, Anxiety and Stress Scales (DASS; Lovibond & Lovibond, 1995), a 21-item self -report questionnaire designed to assess symptoms of anxiety, depression and stress. 3. Quality of Intervention measured using the CHoice of Outcome In Cbt for psychosEs (CHOICE; Greenwood et al., 2010), a 12 item service-user developed questionnaire to evaluate outcomes for people with psychosis and assess therapy-related goals. 4. Recovery measured using the process of recovery questionnaire (QPR; Neil et al., 2009), a user-defined measure, assessing subjective recovery in intrapersonal and interpersonal functioning. 5. Quality of Life measured using the Short Form-36 (SF36; Ware & Sherbourne, 1992) and the EQ-5D (Herdman et al., 2011) 6. Capability measures measured using the Investigating Choice Experiments Capability Measure for Adults (ICECAP-A; Al-Janabi, Flynn & Coast, 2012) 7. Therapeut | — |
Countries
England, United Kingdom
Contacts
Public ContactCharlotte Aynsworth
Outcome results
None listed