8. Suggested design of study.
Methods | Allocation: randomised, fully explicit description of methods of randomisation and allocation concealment. Blinding: single, tested. Setting: community rather than hospital. Duration: 12 weeks treatment, and then follow‐up to at least 52 weeks. |
Participants | Diagnosis: schizophrenia (ICD). N = 300.* Age: adults. Sex: both. |
Interventions | 1. Cognitive behaviour therapy plus standard care. N = 150. Content:
Delivered by: experienced therapists. 2. Other psychosocial therapy plus standard care . N = 150. |
Outcomes | General: time to all‐cause treatment failure marked by its discontinuation, relapse/rehospitalisation, general impression of clinician (CGI), carer/other, compliance with treatment. Mental state: BPRS and PANSS. Global state: CGI (Clinical Global Impression). Quality of life. QOL (Quality of Life Questionnaire). Social functioning: return to everyday living for 80% of time.* Economic outcomes. |
Notes | * Powered to be able to identify a difference of ˜ 20% between groups for primary outcome with adequate degree of certainty. |
BPRS = Brief Psychiatric Rating Scale CGI = ICD = International Classification of Diseases PANSS = Positive and Negative Syndrome Scale QOL =