Psychosis - schizophrenia Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomly allocated to one of two groups and receive either the GiVE intervention (and Treatment-As-Usual) or Treatment-As-Usual alone
GiVE intervention - is described in our publ
Sponsors
Sussex Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. In contact with Secondary Care Mental Health Services (under the care of a mental health team in one of the recruiting Trusts) 2. Have a clinician-reported diagnosis of psychosis 3. Aged 18 yeras or over 4. Willing to provide written, informed consent 5. Experiencing current voice-hearing; this will be operationalised by participants having a score of at least 1 on item 1 (‘Frequently’) on the Psychotic Symptoms Rating Scale - Auditory Hallucinations Scale (PSYRATS-AH) at the time of consent – indicating that the participant has experienced at least one episode of voice-hearing in the past week 6. Scoring 3 or 4 (rated on a 0–4 scale) on either the intensity of distress item or the amount of distress item on PSYRATS-AH at the time of consent.
Exclusion criteria
Exclusion criteria: 1. Established organic cause for distressing voices 2. Primary diagnosis of substance misuse 3. Currently detained in hospital under a section of the Mental Health Act 4. Having completed a full course (minimum of 16 hours) of CBTp for psychotic symptoms during the past year 5. Immediate and serious risk to self or others (assessed at the point of referral/eligibility review).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psychotic Symptoms Rating Scale – Auditory Hallucinations (PSYRATS-AH) – voice-related distress will be measured by the 5-item ‘distress’ subscale at screening/eligibility, 16 weeks and 28 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoints: screening/eligibility (-t1), baseline (-t2), 16 weeks post-randomization (16 weeks) and 28 weeks post-randomization (28 weeks). 1. Secondary (clinical) outcome: Psychotic Symptoms Rating Scale – Auditory Hallucinations (PSYRATS-AH) – the attribution, loudness and frequency of voices will be measured at -t1, 16 weeks and 28 weeks. 2. Secondary (clinical) outcome: Hospital Anxiety and Depression Scale (HADS) – anxiety and depression will be measured at -t2, 16 weeks and 28 weeks. 3. Secondary (clinical) outcome: CHoice of Outcome In Cbt for psychosEs (CHOICE) – recovery will be measured at -t2, 16 weeks and 28 weeks. 4. Secondary (mechanism) outcome: The Brief Core Schema Scale (BCSS) - self scale - the degree of positive and negative beliefs about self will be measured -t2, 16 weeks and 28 weeks. 5. Secondary (mechanism) outcome: Approve – Voices - the styles of relating to voices will be measured at -t2, 16 weeks and 28 weeks. 6. Secondary (mechanism) outcome: Approve – Social - the styles of relating to other people will be measured at -t2, 16 weeks and 28 weeks. 7. Secondary (mechanism) outcome: Beliefs about voices questionnaire - revised (BAVQ-R) – the 14-item version of this measure will capture ‘persecutory beliefs’ and ‘benevolent beliefs’ at -t2, 16 weeks and 28 weeks. 8. Secondary (clinical) outcome: Revised Green Paranoid Thoughts Scale (R-GPTS) – will measure paranoid delusions at -t2, 16 weeks and 28 weeks. 9. Health economic measure: Client Service Receipt Inventory (CSRI-UK) - will be used to collect information on service utilization, income, accommodation, and other cost-related variables at -t2, 16 weeks and 28 weeks. 10. Health economic measure: EQ-5D-5L - will be used as a measure of health-related quality of life relevant to a wide range of health conditions and treatments at -t2, 16 weeks and 28 weeks. 11. Health economic measure: SF-12 v2 – will capture information about functional health and well-being from the patient’s point of v | — |
Countries
England, United Kingdom
Outcome results
None listed