Access, Detection and Psychological Treatments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00260273
Recruitment Status : Unknown
Verified October 2007 by Ontario Mental Health Foundation.
Recruitment status was:  Active, not recruiting
First Posted : December 1, 2005
Last Update Posted : November 8, 2007
Information provided by:
Ontario Mental Health Foundation

Brief Summary:
Schizophrenia is one of society's most costly medical conditions and the most severe among psychiatric disorders. One of the most important and exciting new concepts in psychiatry is that detection and intervention very early in the course of schizophrenia offers what may be the field's best practical hope for realizing substantive improvements in the outcome of schizophrenia or schizophrenia spectrum disorders. Thus, we propose a five year program that focuses on three interconnected major research streams: (1) an evaluation of the effectiveness and cost-effectiveness of a model-driven psychological intervention in preventing or delaying the onset of a psychotic illness; (2) a qualitative study of the pathways to mental health at this time of very high risk; and (3) an exploration of the burden to the healthcare and informal caregiver systems associated with this high risk population.

Condition or disease Intervention/treatment Phase
Psychoses Behavioral: Cognitive Behaviour Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Access, Detection and Psychological Treatments
Study Start Date : August 2004
Estimated Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
cognitive Behavioural Therapy
Behavioral: Cognitive Behaviour Therapy
No Intervention: 2
supportive therapy

Primary Outcome Measures :
  1. Research Stream 1: Treatment and Cost Effectiveness Primary outcome measure: (i) Time to conversion. [ Time Frame: 18 months ]
  2. Research Stream 2: Pathways to Care Primary outcome measure: Pathway to care interview [ Time Frame: 18 months ]
  3. Research Stream 3: Costs of Caring in Psychosis Primary outcome measure: (i) Time to conversion, (ii) costs of formal and informal care giving. [ Time Frame: 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 12-30 years·
  • Meeting criteria for an "at risk mental state" based on one or more of the 3 Criteria of Prodromal Symptoms (COPS criteria) with severity as determined by ratings on the Scale of Prodromal Symptoms (SOPS) or the criteria for attenuated symptoms of the early prodromal state defined by the presence of at least two of 9 symptoms on the Bonn Scale for the Assessment of Basic Symptoms that have been demonstrated to have the best positive predictive value of developing schizophrenia (Klosterkötter et al., 2001). These criteria for the early prodromal state course are currently used in the multi-site European Prediction of Psychosis Study (EPOS) (Birchwood et al., 2002).

Exclusion Criteria:

  • Meets criteria for current or lifetime axis I psychotic disorder.·
  • Meets DSM-IV criteria for an Axis 1 disorder where in the judgment of the evaluating clinician the diagnostic prodromal symptoms are clearly caused by the Axis 1 disorder. Note that, except for bipolar and psychotic disorders and a current major depression other DSM-IV disorders will not be exclusionary (e.g. substance abuse or dependence disorder, major depression, anxiety disorders, Axis II Disorders) as long as the disorder does not account for the diagnosis of prodromal symptoms.·
  • Use of substances where in the judgment of the evaluating clinician, the diagnostic prodromal symptoms are substance-induced.
  • Prior history of treatment with an antipsychotic for the current presenting symptoms or for any previous episode of psychotic symptoms.
  • Impaired intellectual functioning (IQ< than 70).
  • Past or current history of a clinically significant central nervous system disorder which may confound or contribute to prodromal symptoms.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00260273

Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Ontario Mental Health Foundation
Principal Investigator: Jean Addington, PhD Centre for Addiction and Mental Health/ University of Toronto Identifier: NCT00260273     History of Changes
Other Study ID Numbers: 107/2004
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: November 8, 2007
Last Verified: October 2007

Keywords provided by Ontario Mental Health Foundation:
Preventive Therapy
Cognitive Behaviour Therapy

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders