NCT00260273

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

November 8, 2007

Status Verified

October 1, 2007

First QC Date

November 28, 2005

Last Update Submit

November 7, 2007

Conditions

Psychoses

Keywords

Preventive TherapyPsychosesCognitive Behaviour Therapy

Outcome Measures

Primary Outcomes (3)

  • Research Stream 1: Treatment and Cost Effectiveness Primary outcome measure: (i) Time to conversion.

    18 months

  • Research Stream 2: Pathways to Care Primary outcome measure: Pathway to care interview

    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.

    18 months

Study Arms (2)

1

ACTIVE COMPARATOR

cognitive Behavioural Therapy

Behavioral: Cognitive Behaviour Therapy

2

NO INTERVENTION

supportive therapy

Interventions

Cognitive Behaviour TherapyBEHAVIORAL

therapy

1

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Meets criteria for current or lifetime axis I psychotic disorder.·
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jean Addington, PhD

    Centre for Addiction and Mental Health/ University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 28, 2005

First Posted

December 1, 2005

Study Start

August 1, 2004

Study Completion

August 1, 2008

Last Updated

November 8, 2007

Record last verified: 2007-10

Locations

CA(1)