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.

TY - JOUR

T1 - 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.

AU - Bechdolf, Andreas

AU - Müller, Hendrik

AU - Stützer, Hartmut

AU - Wagner, Michael

AU - Maier, Wolfgang

AU - Lautenschlager, Marion

AU - Heinz, Andreas

AU - de Millas, Walter

AU - Janssen, Birgit

AU - Gaebel, Wolfgang

AU - Michel, Tanja Maria

AU - Schneider, Frank

AU - Lambert, Martin

AU - Naber, Dieter

AU - Brüne, Martin

AU - Krüger-Özgürdal, Seza

AU - Wobrock, Thomas

AU - Riedel, Michael

AU - Klosterkötter, Joachim

AU - Group, PREVENT Study

PY - 2011

Y1 - 2011

N2 - 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.

AB - 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.

KW - Adult

KW - Humans

KW - Male

KW - Female

KW - Adolescent

KW - Young Adult

KW - Treatment Outcome

KW - Double-Blind Method

KW - Placebos

KW - Piperazines/therapeutic use

KW - Antipsychotic Agents/therapeutic use

KW - Cognitive Therapy/methods

KW - Combined Modality Therapy/methods

KW - Early Medical Intervention/methods

KW - Psychotic Disorders/drug therapy/prevention & control/therapy

KW - Quinolones/therapeutic use

KW - Adult

KW - Humans

KW - Male

KW - Female

KW - Adolescent

KW - Young Adult

KW - Treatment Outcome

KW - Double-Blind Method

KW - Placebos

KW - Piperazines/therapeutic use

KW - Antipsychotic Agents/therapeutic use

KW - Cognitive Therapy/methods

KW - Combined Modality Therapy/methods

KW - Early Medical Intervention/methods

KW - Psychotic Disorders/drug therapy/prevention & control/therapy

KW - Quinolones/therapeutic use

M3 - SCORING: Journal article

VL - 37 Suppl 2

SP - 111

EP - 121

JO - SCHIZOPHRENIA BULL

JF - SCHIZOPHRENIA BULL

SN - 0586-7614

ER -