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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00722163
Other study ID # 195/2006
Secondary ID
Status Recruiting
Phase Phase 0
First received July 23, 2008
Last updated July 23, 2008
Start date September 2007
Est. completion date March 2013

Study information

Verified date July 2008
Source Ontario Mental Health Foundation
Contact Diane Kirsopp, BA
Phone 416-535-8501
Email diane_kirsopp@camh.net
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Other known NCT identifiers
  • NCT00495911

Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
Cognitive Behavioural Therapy

befriending


Locations

Country Name City State
Canada Centre for Addiction and Mental Health Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Ontario Mental Health Foundation Schizophrenia Society of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

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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