Mental Health / Psychosis Mental and Behavioural Disorders Unspecified nonorganic psychosis
Conditions
Interventions
1. Cognitive Behavioural Therapy, CBT will be delivered by a qualified psychological therapist on an individual basis over 9-months and will include up to 30 treatment sessions on an approximately wee
Sponsors
Greater Manchester West Mental Health NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria from 04/12/2012 (trial record updated 07/03/2014): 1. A criterion level of persistent symptom severity despite an adequate trial of clozapine in terms of dosage, duration and adherence (as used by Honer et al 2006): 1.1. Treatment of clozapine at a stable dose of 400mg or more (unless limited by tolerability) for at least 12 weeks, or if currently augmented with a second antipsychotic that this has been given for at least 12 weeks, without remission of psychotic symptoms, or have discontinued clozapine due to adverse reactions (including agranulocytosis) or lack of efficacy in the past 24 months 1.2. Presence of at least one psychotic symptom with severity =4 (for hallucinations/delusions) or =5 (for suspiciousness/grandiosity) on the PANSS in addition to a PANSS total score of at least 58, which is equivalent to a clinical global impression (CGI) of being at least mildly ill 51 2. Be in contact with mental health services and have a care coordinator 3. Either meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention for Psychosis service (operationally defined using PANSS) in order to allow for diagnostic uncertainty in early phases of psychosis 4. Aged at least 16 years old 5. Competent and willing to provide written, informed consent. Original inclusion criteria: 1. A criterion level of persistent symptom severity despite an adequate trial of clozapine monotherapy in terms of dosage, duration and adherence (as used by Honer et al. 2006): Treatment for at least 24 weeks at a stable dose of 400 mg or more of clozapine a day, unless the size of the dose was limited by side effects, without remission of psychotic symptoms, or have discontinued clozapine due to adverse reactions (including agranulocytosis) or lack of efficacy in the past 24 months. 2. Presence of at least one psychotic symptom with severity 4 (for hallucinations/delusions) or 5 (for suspiciousness/grandiosity) on the Positive and Negative Syndrome Scale (PANSS) in addition to a PANSS total score of at least 58, which is equivalent to a Clinical Global Impression (CGI) of being at least mildly ill. 3. Be in contact with mental health services and have a care coordinator 4. Either meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention for Psychosis service (operationally defined using PANSS) in order to allow for diagnostic uncertainty in early phases of psychosis 5. Male & female aged at least 16 years old 6. Competent and willing to provide written, informed consent
Exclusion criteria
Exclusion criteria: 1. Primary diagnosis of alcohol/substance dependence, where this is clearly the cause of their psychotic symptoms 2. Developmental disability 3. Non-English speaking 4. Current receipt (or within the last 12 months) of structured CBT from a qualified psychological therapist in accordance with NICE guideline recommendations (as opposed to more generic psychosocial interventions)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Alcohol Use Disorder Test (AUDIT) at baseline, 9 months (end of treatment) and 21 months (12 month follow up) 2. Anxious Thoughts Inventory - Meta worry subscale at baseline, 9 months (end of treatment) and 21 months (12 month follow up) 3. Calgary Depression Rating Scale for Schizophrenia at baseline, 9 months (end of treatment) and 21 months (12 month follow up) 4. Common Responses Questionnaire at baseline, 9 months (end of treatment) and 21 months (12 month follow up) 5. Drug Abuse Screening Test (DAST) at baseline, 9 months (end of treatment) and 21 months (12 month follow up) 6. Economic Patient Questionnaire at baseline, 9 months (end of treatment) and 21 months (12 month follow up) 7. PANSS scores at baseline, 9 months (end of treatment) and 21 months (12 month follow up) 8. Personal and Social Performance Scale at baseline, 9 months (end of treatment) and 21 months (12 month follow up) 9. Psychotic Symptoms Rating Scale (PSYRATS) at baseline, 9 months (end of treatment) and 21 months (12 month follow up) 10. The Beliefs about Paranoia Scale at baseline, 9 months (end of treatment) and 21 months (12 month follow up) 11. The Brief Core Schema Scale at baseline, 9 months (end of treatment) and 21 months (12 month follow up) 12. The Childhood Trauma Scale at 9 months (end of treatment) 13. The Internalised Stigma of Mental Illness Scale at baseline, 9 months (end of treatment) and 21 months (12 month follow up) 14. The Interpretation of Voices Inventory at baseline, 9 months (end of treatment) and 21 months (12 month follow up) 15. The Psychosis Attachment Measure at baseline; 9 months (end of treatment) and 21 months (12 month follow up) Added 06/03/2014: 16. The Economic Patient Questionnaire (EPQ), com | — |
Primary
| Measure | Time frame |
|---|---|
| Positive and Negative Syndrome Scale (PANSS) total score at Baseline, 9 months (end of treatment) and 21 months (12 month follow up) | — |
Countries
United Kingdom
Outcome results
None listed