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. 2018 Dec 20;2018(12):CD007964. doi: 10.1002/14651858.CD007964.pub2

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:
  • a discrete psychological intervention, which is in addition to, and separate from, other therapeutic interventions (for example, behavioural family therapy) and

  • recipients establish links between their symptoms, thoughts and beliefs, and consequent distress or problem behaviour, and

  • the re‐evaluation of their perceptions, beliefs or reasoning relating to the target symptoms; this may include the re‐evaluation of specific 'inferential' beliefs or more global 'evaluative' beliefs.


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 =