title: Rationale and baseline characteristics of PREVENT: a second-generation intervention trial in subjects at-risk (prodromal) of developing first-episode psychosis evaluating cognitive behavior therapy, aripiprazole, and placebo for the prevention of psychosis.
abstract: Antipsychotics, cognitive behavioral therapy (CBT), and omega-3-fatty acids have been found superior to control conditions as regards prevention of psychosis in people at-risk of first-episode psychosis. However, no large-scale trial evaluating the differential efficacy of CBT and antipsychotics has been performed yet. In PREVENT, we evaluate CBT, aripiprazole, and clinical management (CM) as well as placebo and CM for the prevention of psychosis in a randomized, double-blind, placebo-controlled trial with regard to the antipsychotic intervention and a randomized controlled trial with regard to the CBT intervention with blinded ratings. The hypotheses are first that CBT and aripiprazole and CM are superior to placebo and CM and second that CBT is not inferior to aripiprazole and CM combined. The primary outcome is transition to psychosis. By November 2010, 156 patients were recruited into the trial. The subjects were substantially functionally compromised (Social and Occupational Functioning Assessment Scale mean score 52.5) and 78.3% presented with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition axis I comorbid diagnosis. Prior to randomization, 51.5% of the participants preferred to be randomized into the CBT arm, whereas only 12.9% preferred pharmacological treatment. First, assessments of audiotaped treatment sessions confirmed the application of CBT-specific skills in the CBT condition and the absence of those in CM. The overall quality rating of the CBT techniques applied in the CBT condition was good. When the final results of the trial are available, PREVENT will substantially expand the current limited evidence base for best clinical practice in people at-risk (prodromal) of first-episode psychosis.
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Cologne, Kerpener Str. 62, 50924 Cologne, Germany. andreas.bechdolf@uk-koeln.de
authors.forename: Andreas
authors.initials: A
authors.lastname: Bechdolf
authors.forename: Hendrik
authors.initials: H
authors.lastname: Müller
authors.forename: Hartmut
authors.initials: H
authors.lastname: Stützer
authors.forename: Michael
authors.initials: M
authors.lastname: Wagner
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Maier
authors.forename: Marion
authors.initials: M
authors.lastname: Lautenschlager
authors.forename: Andreas
authors.initials: A
authors.lastname: Heinz
authors.forename: Walter
authors.initials: W
authors.lastname: de Millas
authors.forename: Birgit
authors.initials: B
authors.lastname: Janssen
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Gaebel
authors.forename: Tanja Maria
authors.initials: TM
authors.lastname: Michel
authors.forename: Frank
authors.initials: F
authors.lastname: Schneider
authors.forename: Martin
authors.initials: M
authors.lastname: Lambert
authors.forename: Dieter
authors.initials: D
authors.lastname: Naber
authors.forename: Martin
authors.initials: M
authors.lastname: Brüne
authors.forename: Seza
authors.initials: S
authors.lastname: Krüger-Özgürdal
authors.forename: Thomas
authors.initials: T
authors.lastname: Wobrock
authors.forename: Michael
authors.initials: M
authors.lastname: Riedel
authors.forename: Joachim
authors.initials: J
authors.lastname: Klosterkötter
mesh_terms: D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003131:Combined Modality Therapy / Q000379:methods*; D004311:Double-Blind Method; D061345:Early Medical Intervention / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D010879:Piperazines / Q000627:therapeutic use*; D010919:Placebos; D011618:Psychotic Disorders / Q000188:drug therapy / Q000517:prevention & control* / Q000628:therapy; D015363:Quinolones / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D010919:Placebos; D015363:Quinolones; D000068180:Aripiprazole