3. Suggested design for future trial.
| Methods | Participants | Interventions | Outcomes |
| Allocation: randomised, clearly described | Diagnosis: people with schizophrenia or related disorders and history of aggressive behaviours | 1. CBT plus standard care1 | Aggression:
Agitation:
|
| Blinding: outcome assessors (due to nature of intervention) | N ~ 3002 | 2. Standard care3 | Self‐harm:
Adverse effects/events:
|
| Duration: 3 to 6 months (endpoint), 6 to 12 months (follow‐up) | Global state:
Leaving the study early:
Others:
|
CBT: cognitive behavioural therapy.
1Psychological therapy for cognitive restructure of thoughts, emotions and behaviours that usually includes cognitive therapy and elements of behavioural therapy delivered individually or concurrently
32 Powered to be able to identify a difference of ~20% between groups for primary outcome with adequate degree of certainty.
3Normal level of care participants would receive for their condition