Topic: Mental Health Research Network
Conditions
Interventions
Description: We aim to have usable data on 60 participants. If we recruit 75 participants (25 per condition) over the 28-month recruitment period this would allow for a dropout rate of 20%.
Antipsych
the responsible consultant psychiatrists will choose the individual AP before randomisation.
Cognitive behaviour therapy: Up to 25 sessions will be delivered over the 6-month treatment period.
Comb
Sponsors
Greater Manchester West Mental Health NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 25/07/2014: 1. In contact with mental health care services (under the care of a consultant) 2. 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 3. Aged 16+ 4. Competent and willing to provide written, informed consent 5. Score at least 4 on PANSS delusions or hallucinations or at least 5 on Suspiciousness/Grandiosity 6. Help seeking Previous inclusion criteria: 1. Aged 18+ 2. In contact with mental health services 3. Competent to provide written, informed consent. 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. Score at least 4 on PANSS delusions or hallucinations or at least 5 on suspiciousness/grandiosity 6. Help seeking
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 25/07/2014: 1. Primary diagnosis of alcohol/substance misuse 2. Moderate or severe learning disability 3. Score 5+ on PANSS conceptual disorganisation 4. Non-English speaking 5. Current receipt of structured CBT from a qualified psychologist in accordance with NICE guideline recommendations (as opposed to more generic psychosocial interventions) OR receipt of antipsychotics, OR receipt of either within the past 3 months. 6. Immediate risk to self or others 7. Organic Impairment Previous exclusion criteria: 1. Primary diagnosis of alcohol/substance dependence 2. Moderate or severe learning disability 3. Score 5+ on PANSS conceptual disorganisation 4. Non-English speaking 5. Current receipt of structured CBT or APs, or receipt within the last 3 months 6. Inpatient 7. Immediate risk to self or others 8. Organic Impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive and Negative Syndrome Scale (PANSS); Timepoint(s): 6 weeks, 12 weeks, 24 weeks, 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical Global Impression scales (CGI); Timepoint(s): 6 weeks, 12 weeks, 24 weeks, 52 weeks 2. Hospital Anxiety and Depression Scale (HADS); Timepoint(s): 24 weeks, 52 weeks 3. Personal and social performance scale (PSP); Timepoint(s): 24 weeks, 52 weeks 4. Questionnaire about the process of Recovery (QPR); Timepoint(s): 24 weeks, 52 weeks 5. WHOQOL- quality of life; Timepoint(s): 6 weeks, 12 weeks, 24 weeks and 52 weeks | — |
Countries
United Kingdom
Outcome results
None listed