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. 2024 May 7;2024(5):CD009531. doi: 10.1002/14651858.CD009531.pub3

5. Future study design.

Study design Study design Recommendation
Setting   Primary care and community mental healthcare services
Method Duration Minimum of 12‐month follow‐up
  Allocation Randomised (cluster or individual)
  Blinding Blinding of outcome assessors
Blinding of statisticians
Allocation concealment
  Outcomes
  • Psychiatric admissions

  • Intervention costs

  • Quality of life

  • Mental state

  • Social functioning

  • Personal recovery

  • Adverse effects, e.g. acute mental health episodes (defined as number of crises in time period)

  • Process outcomes

  • Experience of care/satisfaction

  • Fidelity


Core outcome set for bipolar I and II (Retzer 2020)
  Retention Utilise participant retention strategies
  Analysis Produce and report analysis plans prior to research being conducted
Participants Diagnosis Severe mental illness
  Age 18+ (or younger if in receipt of adult services)
  Gender All
  N 300+
Intervention   Collaborative care according to Gunn 2006 description to include:
  • Multidisciplinary working (which includes primary care)

  • Enhanced communication between providers (e.g. via case manager, multidisciplinary team meetings)

  • Scheduled and proactive follow‐up

  • Delivery of evidence‐based treatment according to algorithms/protocols