Randomized controlled trial of interventions for young people at ultra-high risk of psychosis: study design and baseline characteristics.
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.
Phillips
Lisa J
LJ
Department of Psychology, University of Melbourne, Melbourne, Victoria 3010, Australia. lisajp@unimelb.edu.au
Nelson
Barnaby
B
Yuen
Hok Pan
HP
Francey
Shona M
SM
Simmons
Magenta
M
Stanford
Carrie
C
Ross
Margaret
M
Kelly
Daniel
D
Baker
Kathryn
K
Conus
Philippe
P
Amminger
Paul
P
Trumpler
Francois
F
Yun
Yang
Y
Lim
Michelle
M
McNab
Catharine
C
Yung
Alison R
AR
McGorry
Patrick D
PD
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*
D010919:Placebos; D018967:Risperidone