title: Early detection and intervention evaluation for people at risk of psychosis: multisite randomised controlled trial.
abstract: OBJECTIVE
  To determine whether cognitive therapy is effective in preventing the worsening of emerging psychotic symptoms experienced by help seeking young people deemed to be at risk for serious conditions such as schizophrenia.
  
  
  METHODS
  Multisite single blind randomised controlled trial.
  
  
  METHODS
  Diverse services at five UK sites.
  
  
  METHODS
  288 participants aged 14-35 years (mean 20.74, SD 4.34 years) at high risk of psychosis: 144 were assigned to cognitive therapy plus monitoring of mental state and 144 to monitoring of mental state only. Participants were followed-up for a minimum of 12 months and a maximum of 24 months.
  
  
  METHODS
  Cognitive therapy (up to 26 (mean 9.1) sessions over six months) plus monitoring of mental state compared with monitoring of mental state only.
  
  
  METHODS
  Primary outcome was scores on the comprehensive assessment of at risk mental states (CAARMS), which provides a dichotomous transition to psychosis score and ordinal scores for severity of psychotic symptoms and distress. Secondary outcomes included emotional dysfunction and quality of life.
  
  
  RESULTS
  Transition to psychosis based on intention to treat was analysed using discrete time survival models. Overall, the prevalence of transition was lower than expected (23/288; 8%), with no significant difference between the two groups (proportional odds ratio 0.73, 95% confidence interval 0.32 to 1.68). Changes in severity of symptoms and distress, as well as secondary outcomes, were analysed using random effects regression (analysis of covariance) adjusted for site and baseline symptoms. Distress from psychotic symptoms did not differ (estimated difference at 12 months -3.00, 95% confidence interval -6.95 to 0.94) but their severity was significantly reduced in the group assigned to cognitive therapy (estimated between group effect size at 12 months -3.67, -6.71 to -0.64, P=0.018).
  
  
  CONCLUSIONS
  Cognitive therapy plus monitoring did not significantly reduce transition to psychosis or symptom related distress but reduced the severity of psychotic symptoms in young people at high risk. Most participants in both groups improved over time. The results have important implications for the at risk mental state concept.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN56283883.
authors.affiliation: School of Psychological Sciences, University of Manchester, Manchester M13 9PL, UK. tony.morrison@manchester.ac.uk
authors.forename: Anthony P
authors.initials: AP
authors.lastname: Morrison
authors.forename: Paul
authors.initials: P
authors.lastname: French
authors.forename: Suzanne L K
authors.initials: SL
authors.lastname: Stewart
authors.forename: Max
authors.initials: M
authors.lastname: Birchwood
authors.forename: David
authors.initials: D
authors.lastname: Fowler
authors.forename: Andrew I
authors.initials: AI
authors.lastname: Gumley
authors.forename: Peter B
authors.initials: PB
authors.lastname: Jones
authors.forename: Richard P
authors.initials: RP
authors.lastname: Bentall
authors.forename: Shôn W
authors.initials: SW
authors.lastname: Lewis
authors.forename: Graham K
authors.initials: GK
authors.lastname: Murray
authors.forename: Paul
authors.initials: P
authors.lastname: Patterson
authors.forename: Kat
authors.initials: K
authors.lastname: Brunet
authors.forename: Jennie
authors.initials: J
authors.lastname: Conroy
authors.forename: Sophie
authors.initials: S
authors.lastname: Parker
authors.forename: Tony
authors.initials: T
authors.lastname: Reilly
authors.forename: Rory
authors.initials: R
authors.lastname: Byrne
authors.forename: Linda M
authors.initials: LM
authors.lastname: Davies
authors.forename: Graham
authors.initials: G
authors.lastname: Dunn
mesh_terms: D000293:Adolescent; D000328:Adult; D015928:Cognitive Behavioral Therapy; D042241:Early Diagnosis; D006801:Humans; D001523:Mental Disorders / Q000175:diagnosis / Q000517:prevention & control / Q000628:therapy*; D011618:Psychotic Disorders / Q000517:prevention & control*; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult