A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis

Conditions
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Psychosis

Intervention / Treatment
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* Other: Cognitive Behavioural Therapy
* Other: befriending


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stabilized outpatients, ages 16 to 35 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. are competent and willing to give consent are within 12 months of admission to the FEPP for a FE. Exclusion: serious risk of suicide or violence to others a primary diagnosis of drug-induced psychosis or psychosis due to a general medical condition.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>behavioural | Other: Cognitive Behavioural Therapy<br> <br> |
| Active Comparator: 2<br>befriending | Other: befriending<br> <br> |
| No Intervention: 3<br>TAU | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Functioning |  | 18 months | 
| Positive & negative symptoms |  | 18 months | 
| Individual dimensions of psychotic symptoms |  | 18 months | 
| Depression |  | 18 months | 
| Substance use |  | 18 months | 
| Alcohol and Drug Use |  | 18 months | 
| Medication adherenceAdaptation to illness |  | 18 months | 
| Self Esteem |  | 18 months | 
| Coping Skills (MACS) |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioural therapy, Psychosis