title: Randomized controlled trial of interventions for young people at ultra-high risk of psychosis: study design and baseline characteristics.
abstract: OBJECTIVE
  Intervention during the pre-psychotic period of illness holds the potential of delaying or even preventing the onset of a full-threshold disorder, or at least of reducing the impact of such a disorder if it does develop. The first step in realizing this aim was achieved more than 10 years ago with the development and validation of criteria for the identification of young people at ultra-high risk (UHR) of psychosis. Results of three clinical trials have been published that provide mixed support for the effectiveness of psychological and pharmacological interventions in preventing the onset of psychotic disorder.
  
  
  METHODS
  The present paper describes a fourth study that has now been undertaken in which young people who met UHR criteria were randomized to one of three treatment groups: cognitive therapy plus risperidone (CogTher + Risp: n = 43); cognitive therapy plus placebo (CogTher + Placebo: n = 44); and supportive counselling + placebo (Supp + Placebo; n = 28). A fourth group of young people who did not agree to randomization were also followed up (monitoring: n = 78). Baseline characteristics of participants are provided.
  
  
  CONCLUSIONS
  The present study improves on the previous studies because treatment was provided for 12 months and the independent contributions of psychological and pharmacological treatments in preventing transition to psychosis in the UHR cohort and on levels of psychopathology and functioning can be directly compared. Issues associated with recruitment and randomization are discussed.
authors: Department of Psychology, University of Melbourne, Melbourne, Victoria 3010, Australia. lisajp@unimelb.edu.au
authors: Lisa J
authors: LJ
authors: Phillips
authors: Barnaby
authors: B
authors: Nelson
authors: Hok Pan
authors: HP
authors: Yuen
authors: Shona M
authors: SM
authors: Francey
authors: Magenta
authors: M
authors: Simmons
authors: Carrie
authors: C
authors: Stanford
authors: Margaret
authors: M
authors: Ross
authors: Daniel
authors: D
authors: Kelly
authors: Kathryn
authors: K
authors: Baker
authors: Philippe
authors: P
authors: Conus
authors: Paul
authors: P
authors: Amminger
authors: Francois
authors: F
authors: Trumpler
authors: Yang
authors: Y
authors: Yun
authors: Michelle
authors: M
authors: Lim
authors: Catharine
authors: C
authors: McNab
authors: Alison R
authors: AR
authors: Yung
authors: Patrick D
authors: PD
authors: McGorry
mesh_terms: D000293:Adolescent; D000328:Adult; D015928:Cognitive Behavioral Therapy; D003376:Counseling; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D018579:Patient Selection; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D011618:Psychotic Disorders / Q000188:drug therapy / Q000517:prevention & control* / Q000628:therapy; D045808:Refusal to Participate; D012107:Research Design; D012306:Risk; D018967:Risperidone / Q000627:therapeutic use*
chemical_list: D010919:Placebos; D018967:Risperidone