Psychosis Clinical Trial
— PSTEPOfficial title:
A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis
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.
Status | Recruiting |
Enrollment | 330 |
Est. completion date | March 2013 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 35 Years |
Eligibility |
Inclusion Criteria: 1. stabilized outpatients, 2. ages 16 to 35 3. meet DSM-IV criteria for: schizophrenia, schizophreniform disorder, brief psychotic disorder, delusional disorder, schizoaffective disorder, substance induced psychotic disorder, or psychotic disorder NOS. Participants who also meet DSM-IV criteria for substance abuse or dependence will not be excluded. 4. are competent and willing to give consent 5. are within 12 months of admission to the FEPP for a FE. Exclusion: 1. serious risk of suicide or violence to others 2. a primary diagnosis of drug-induced psychosis or psychosis due to a general medical condition. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ontario Mental Health Foundation | Schizophrenia Society of Ontario |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Social Functioning | 18 months | No | |
Primary | Positive & negative symptoms | 18 months | No | |
Primary | Individual dimensions of psychotic symptoms | 18 months | No | |
Primary | Depression | 18 months | No | |
Primary | Substance use | 18 months | No | |
Primary | Alcohol and Drug Use | 18 months | No | |
Primary | Medication adherenceAdaptation to illness | 18 months | No | |
Primary | Self Esteem | 18 months | No | |
Primary | Coping Skills (MACS) | 18 months | No |
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