Schizophrenia spectrum disorder Mental and Behavioural Disorders Schizophrenia, schizotypal and delusional disorders
Conditions
Interventions
Randomisation is done in the ratio 1:1 to the two groups and is independent and concealed using randomised-permuted blocks of 6-8 administered via an encrypted web-based system. Participants are then
Sponsors
Greater Manchester Mental Health NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/05/2019: 1. Adults aged =18 years 2. Who have heard voices for at least one year and score =4 on the auditory hallucination subscale of the Positive and Negative Syndrome Scale (PANSS) 3. Who have had no changes to medication within the past month 4. Who meet criteria for ICD schizophrenia spectrum disorder 5. Who are able to provide written, informed consent 6. Who are not currently receiving structured psychological therapy for psychosis 7. Who are in contact with secondary care mental health services and have a care coordinator 8. Who are willing and able to communicate with their voices and relay what the voices say to a therapist 9. Whose voices are sufficiently personified to engage in dialogical work (i.e., voices which can engage in conversation and dynamically interact with the hearer) Previous inclusion criteria from 07/06/2018 to 15/05/2019: 1. Aged =18 years 2. Has heard voices for at least 1 year and score =4 on the auditory hallucination subscale of the Positive and Negative Syndrome Scale (PANSS) 3. Has had no changes to medication within the past month 4. Meets criteria for ICD schizophrenia spectrum disorder 5. Able to provide written, informed consent 6. Not currently receiving structured psychological therapy for psychosis 7. In contact with secondary care mental health services and has a care coordinator 8. Willing and able to communicate with the voices and relay what the voices say to a therapist 9. Voices are sufficiently personified to engage in dialogical work (i.e. voices that can engage in conversation and dynamically interact with the hearer) Original inclusion criteria: 1. Aged =18 2. Have heard voices for at least one year and score =4 on the auditory hallucination subscale of the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) 3. Have had no changes to medication within the past month 4. Have a lifetime diagnosis of ICD schizophrenia spectrum disorder 5. Able to provide written, informed consent 6. Not currently receiving, or waiting to receive, cognitive behavioural therapy for psychosis 7. Willing and able to communicate with their voices and relay what the voices say to a therapist 8. Whose voices are sufficiently personified to engage in dialogical work (i.e. voices which can engage in conversation and dynamically interact with the hearer) 9. No restrictions have been placed on recruitment according to gender
Exclusion criteria
Exclusion criteria: 1. At immediate risk of harm to self or others 2. Non-English speaking 3. Primary diagnosis of alcohol/substance dependence or autism spectrum disorder 4. Moderate/severe learning disability 5. Organic brain injury or illness implicated in the aetiology of psychotic symptoms 6. A score of > 5 on the conceptual disorganisation subscale of the Positive and Negative Syndrome Scale for Schizophrenia 7. Homeless and/or of no fixed abode
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As this is a feasibility trial, a single primary outcome is not meaningful. Key outcomes to inform the design of a future definitive trial are: 1. Referral rates and recruitment rates, which will be assessed at the end of the recruitment period in April 2019. 2. Attendance at, and engagement with, therapy sessions; and follow-up and questionnaire response rates, which will be assessed at the end of the follow-up period in October 2019. 3. Acceptability of treatment, which will be assessed using drop-out rates at the end of the follow-up period by October 2019. Added 27/06/2019: Progression criteria relate to recruitment, retention, adherence and data completeness and will have stop/refine/go (red/amber/green) criteria. The suggested criteria and cut-offs are: 1. Recruitment: Green >= 80% of target; Amber 60-79%; Red = 80%; Amber 60-79%; Red = 80% attending at least 8 sessions; Amber 60-79%; Red <= 59%. Eight sessions has been agreed to constitute a therapeutic ‘dose’ | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary outcomes are being collected to determine their suitability for use in a subsequent trial, rather than to draw conclusions about the safety or efficacy of the intervention: 1. Relationship with voices is measured using The Voice and You scale (VAY) at baseline and at six months post randomisation 2. Beliefs about voices are measured using The Revised Beliefs about Voices Questionnaire (BAVQ-R) at baseline and at six months post randomisation 3. Voice hearing phenomenology is measured using The Subtypes of Voice Hearing Questionnaire (SOV-Q) at baseline and at six months post randomisation 4. Dissociation is measured using The Revised Dissociative Experiences Scale (DES-II) at baseline and at six months post randomisation 5. Psychotic symptomology is measured using The Positive and Negative Syndrome Scale (PANSS) at baseline and at six months post randomisation 6. Social and occupational functioning is measured using The Questionnaire about the Process of Recovery (QPR) at baseline and at six months post randomisation 7. General health status is measured using the EQ-5D at baseline and at six months post randomisation | — |
Countries
England, United Kingdom
Outcome results
None listed