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Sponsors and Collaborators: |
Ontario Mental Health Foundation Schizophrenia Society of Ontario |
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Information provided by: | Ontario Mental Health Foundation |
ClinicalTrials.gov Identifier: | NCT00722163 |
In the first year of treatment after a FE of SCZ, 75% to 90% of patients achieve remission from psychotic symptoms. However, approximately 40% of FE patients are non-adherent to medication regimes and more than 60% have intermittent periods of gaps of non-adherence. Relapse rates are high with 82% of patients relapsing at least once within 5 years. Unfortunately even amongst those who do achieve full remission from psychotic symptoms, functional recovery remains a major challenge for patients. All the evidence suggests that individuals with SCZ do best with a combination of pharmacology and psychosocial intervention. Cognitive-behavior therapy (CBT) is gaining recognition as an effective treatment in SCZ and is in fact the only psychosocial treatment in SCZ with proven durability at short term follow-up. Although it is currently being used, the investigators need to learn more about the impact of CBT on FE SCZ especially as experts are advocating for CBT to be a critical component of FE clinical services.
Condition | Intervention | Phase |
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Psychosis |
Other: Cognitive Behavioural Therapy Other: befriending |
Phase 0 |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis |
Estimated Enrollment: | 330 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
behavioural
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Other: Cognitive Behavioural Therapy |
2: Active Comparator
befriending
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Other: befriending |
3: No Intervention
TAU
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The primary problem to be addressed is the incomplete functional recovery following a FE of SCZ and whether CBT is an effective treatment to aid this recovery. If CBT were to positively impact recovery in the FE we then need to address (i) which mechanisms are responsible for this improvement, and (ii) whether this treatment is effective for all FE patients.
Ages Eligible for Study: | 16 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion:
Contact: Diane Kirsopp, BA | 416-535-8501 ext 6288 | diane_kirsopp@camh.net |
Canada, Ontario | |
Centre for Addiction and Mental Health | Recruiting |
Toronto, Ontario, Canada, M5T 1R8 | |
Principal Investigator: Jean Addington, PHD |
Principal Investigator: | Jean Addington, PhD | Centre for Addiction and Mental Health |
Responsible Party: | Centre for Addiction and Mental Health ( Dr. Jean Addington ) |
Study ID Numbers: | 195/2006 |
Study First Received: | July 23, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00722163 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Cognitive Behavioural therapy Psychosis |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |