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

July 23, 2008 updated by: Ontario Mental Health Foundation
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

330

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 1R8
        • Recruiting
        • Centre for Addiction and Mental Health
        • Principal Investigator:
          • Jean Addington, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Mental Health Foundation

Collaborators

Schizophrenia Society of Ontario

Investigators

  • Principal Investigator: Jean Addington, PhD, Centre for Addiction and Mental Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Anticipated)

May 1, 2009

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 23, 2008

First Posted (Estimate)

July 25, 2008

Study Record Updates

Last Update Posted (Estimate)

July 25, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 195/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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