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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Ontario Mental Health Foundation.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Schizophrenia Society of Ontario
Information provided by:
Ontario Mental Health Foundation
ClinicalTrials.gov Identifier:
NCT00722163
First received: July 23, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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
Psychosis
 Other: Cognitive Behavioural Therapy
Other: befriending
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ontario Mental Health Foundation:

Primary Outcome Measures:
  • Social Functioning [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Positive & negative symptoms [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Individual dimensions of psychotic symptoms [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Substance use [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Alcohol and Drug Use [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Medication adherenceAdaptation to illness [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Self Esteem [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Coping Skills (MACS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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
Experimental: 1
behavioural
 Other: Cognitive Behavioural Therapy
Active Comparator: 2
befriending
 Other: befriending
No Intervention: 3
TAU

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.

  Eligibility

Ages Eligible for Study:   16 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722163

Contacts
Contact: Diane Kirsopp, BA 416-535-8501 ext 6288 diane_kirsopp@camh.net

Locations
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
Investigators
Principal Investigator: Jean Addington, PhD Centre for Addiction and Mental Health
  More Information

No publications provided

Responsible Party: Dr. Jean Addington, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00722163     History of Changes
Obsolete Identifiers: NCT00495911
Other Study ID Numbers: 195/2006
Study First Received: July 23, 2008
Last Updated: July 23, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ontario Mental Health Foundation:
Cognitive Behavioural therapy
Psychosis

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on June 18, 2013