A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis (PSTEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00722163
Recruitment Status : Unknown
Verified July 2008 by Ontario Mental Health Foundation.
Recruitment status was:  Recruiting
First Posted : July 25, 2008
Last Update Posted : July 25, 2008
Schizophrenia Society of Ontario
Information provided by:
Ontario Mental Health Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Psychosis Other: Cognitive Behavioural Therapy Other: befriending Early Phase 1

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Official Title: A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis
Study Start Date : September 2007
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Other: Cognitive Behavioural Therapy
Active Comparator: 2
Other: befriending
No Intervention: 3

Primary Outcome Measures :
  1. Social Functioning [ Time Frame: 18 months ]
  2. Positive & negative symptoms [ Time Frame: 18 months ]
  3. Individual dimensions of psychotic symptoms [ Time Frame: 18 months ]
  4. Depression [ Time Frame: 18 months ]
  5. Substance use [ Time Frame: 18 months ]
  6. Alcohol and Drug Use [ Time Frame: 18 months ]
  7. Medication adherenceAdaptation to illness [ Time Frame: 18 months ]
  8. Self Esteem [ Time Frame: 18 months ]
  9. Coping Skills (MACS) [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00722163

Contact: Diane Kirsopp, BA 416-535-8501 ext 6288

Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5T 1R8
Principal Investigator: Jean Addington, PHD         
Sponsors and Collaborators
Ontario Mental Health Foundation
Schizophrenia Society of Ontario
Principal Investigator: Jean Addington, PhD Centre for Addiction and Mental Health

Responsible Party: Dr. Jean Addington, Centre for Addiction and Mental Health Identifier: NCT00722163     History of Changes
Obsolete Identifiers: NCT00495911
Other Study ID Numbers: 195/2006
First Posted: July 25, 2008    Key Record Dates
Last Update Posted: July 25, 2008
Last Verified: July 2008

Keywords provided by Ontario Mental Health Foundation:
Cognitive Behavioural therapy

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders