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Access, Detection and Psychological Treatments

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Ontario Mental Health Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ontario Mental Health Foundation
ClinicalTrials.gov Identifier:
NCT00260273
First received: November 28, 2005
Last updated: November 7, 2007
Last verified: October 2007
History of Changes
  Purpose

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 Intervention
Psychoses
 Behavioral: Cognitive Behaviour Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Access, Detection and Psychological Treatments

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ontario Mental Health Foundation:

Primary Outcome Measures:
  • Research Stream 1: Treatment and Cost Effectiveness Primary outcome measure: (i) Time to conversion. [ Time Frame: 18 months ]
  • Research Stream 2: Pathways to Care Primary outcome measure: Pathway to care interview [ Time Frame: 18 months ]
  • 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 ]

Enrollment: 56
Study Start Date: August 2004
Estimated Study Completion Date: August 2008
Arms Assigned Interventions
Active Comparator: 1
cognitive Behavioural Therapy
 Behavioral: Cognitive Behaviour Therapy
therapy
No Intervention: 2
supportive therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260273

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Ontario Mental Health Foundation
Investigators
Principal Investigator: Jean Addington, PhD Centre for Addiction and Mental Health/ University of Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00260273     History of Changes
Other Study ID Numbers: 107/2004
Study First Received: November 28, 2005
Last Updated: November 7, 2007
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 23, 2013