Project 170515

A Randomized Controlled Evaluation of "Extended Specialized Early Intervention Service" vs "Regular care" for Management of Early Psychosis over the Five year Critical Period

170515

A Randomized Controlled Evaluation of "Extended Specialized Early Intervention Service" vs "Regular care" for Management of Early Psychosis over the Five year Critical Period

$2,367,886
Project Information
Study Type: Interventional Randomized_Controlled_Trial
Therapeutic Area: Psychiatry
Research Theme: Clinical
Disease Area: schizophrenia and psychotic disorders
Data Type: Canadian
Institution & Funding
Principal Investigator(s): Malla, Ashok K; Joober, Ridha
Co-Investigator(s): Abdel-Baki, Amal M; Brown, Thomas G; Iyer, Srividya N; Latimer, Eric A; Nordentoft, Merete; Norman, Ross M; Schmitz, Norbert
Institution: CIUSSS de l'Ouest-de-l'Ile-de-Montréal-Douglas Hospital
CIHR Institute: Neurosciences, Mental Health and Addiction
Program: Randomized Controlled Trials
Peer Review Committee: Randomized Controlled Trials - A (RSA)
Competition Year: 2008
Term: 5 yrs 0 mth
Abstract Summary

The generally poor long term outcome in schizophrenia and related psychotic disorders is established relatively early in the first five "critical" years after onset. Specialized Early Intervention (SEI) service is a relatively new concept in mental health and is designed to improve outcome through provision of a comprehensive package of phase specific interventions provided early in the course of these disorders. While the results of this early intervention approach to treatment of a first episode of psychosis (FEP) for outcome in the first two years are encouraging, these benefits are not sustained over the subsequent three years if the person is transferred back to routine mental health care. We, therefore, propose to conduct a randomized controlled study of FEP patients who have already received two years of specialized treatment by comparing the effectiveness of extending the SEI service for another three years with patients who after the first two years of SEI are transferred to routine care which is what they would expect to receive under current circumstances. We will also assess the cost-effectiveness of this approach. This study would provide us answers to the question whether a specialized early intervention approach should extend to the entire risk period of the first five years.

Research Characteristics

This project includes the following research characteristics:

Cost Effectiveness
Budget Impact
Health Technology Assessment
Resource Utilization
Productivity Outcomes
Implementation Science
Policy Evaluation
Health System Integration
Scalability Assessment
Barrier Identification
Patient Reported Outcomes
Real World Evidence
Patient Engagement
Community Based
International Collaboration
International Network
Safety Focus
Quality of Life
Time to Event
Composite Endpoint
Vulnerable Populations
Combination Therapy
Personalized Medicine
Study Justification

"poor long term outcome in schizophrenia and related psychotic disorders is established relatively early in the first five critical years after onset"

Novelty Statement

"comparing effectiveness of extending specialized early intervention service for three additional years versus transfer to routine care after initial two years of specialized treatment"

Keywords
Controlled Trial First Episode Multicenter Psychosis Routine Care Specialized Early Intervention