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. 2019 Nov 1;2019(11):CD012236. doi: 10.1002/14651858.CD012236.pub2

ISRCTN42478021.

Trial name or title Combined individual and family cognitive behavioural therapy compared with treatment as usual
Methods Allocation: randomised (using secure telephone, 1:1 ratio)
Blinding: double
Setting: UK
Inclusion criteria: aged 16‐35 years, screen positive on CAARMS for at‐risk mental state, living with at least one member of their family, help seeking
Exclusion criteria: receipt of antipsychotic drugs, moderate‐severe learning disability, organic impairment, insufficient fluency in English
Duration: 12 months
Participants Diagnosis: UHR for psychosis
N = 76
Age: 16‐35 years
Sex: men and women
Interventions 1. Individual + family therapy: maximum 25 individual therapy sessions, ˜1/week, 1 h, over 6 months, (focusing on whatever most concerned participant) + 4‐6 sessions of CBT with key family members or family support members (focusing on making sense of experiences, communication styles, problem solving and goal setting) + TAU, routine care from their care team or GP
2. TAU
Outcomes Mental state: transition to psychosis (CAARMS defined), BDI, SIAS
Health and social care: adapted EPQ, EQ‐5D
Starting date March 2016
Contact information Greater Manchester West Mental Health NHS Foundation Trust Psychosis Research Unit, Rico House, Harrop House, Bury New Road
Notes Protocol registration: ISRCTN42478021