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. 2023 Jul 25;2023(7):CD013511. doi: 10.1002/14651858.CD013511.pub2

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:
  • Episodes of aggression (physical or verbal)

  • Average endpoint or change score on aggression scale


Agitation:
  • Frequency of agitation

  • Average endpoint or change score on agitation scale

Blinding: outcome assessors (due to nature of intervention) N ~ 3002 2. Standard care3 Self‐harm:
  • Suicide

  • Frequency of self‐harm


Adverse effects/events:
  • Clinically important events

Duration: 3 to 6 months (endpoint), 6 to 12 months (follow‐up)     Global state:
  • Use of additional medication (not intervention medication)

  • Use of restraints or seclusion


Leaving the study early:
  • For any reason

  • For a specific reason


Others:
  • Number of new admissions to health and correctional services

  • Number of new contacts with mental services, justice system or police

  • Compliance with treatment

  • Psychiatric symptoms

  • Level of functioning

  • Number of relapses

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