NCT00358709

Brief Summary

To verify the efficacy of a group cognitive-behavioral therapy approach to lessening psychotic symptoms of individuals with a first episode of psychosis, and to compare its effects to a known skills training approach and a control group. Our primary hypotheses were that CBT would do better than the control group at all points in time, and better than the skills training approach, though only at follow-ups

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_3 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 19, 2008

Status Verified

June 1, 2008

Enrollment Period

4.5 years

First QC Date

July 28, 2006

Last Update Submit

June 18, 2008

Conditions

Schizophrenia

Keywords

Cognitive-behavioral therapysymptom managementfirst psychotic episode

Outcome Measures

Primary Outcomes (1)

  • Expected effects on symptoms, measured before beginning of treatment, three months, nine-months, and 15-months follow-ups

    15 months

Secondary Outcomes (1)

  • Self-esteem, social adaptation, coping, insight, substance abuse, measured before beginning treatment, three months, nine-months, and 15-months follow-ups

    15 months

Interventions

Cognitive-Behavioral therapy and Symptom ManagementBEHAVIORAL

A group cognitive-behavioral therapy approach to lessening psychotic symptoms of individuals with a first episode of psychosis, and comparison its effects to a known skills training approach and a control group.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \) less than two years since their first consultation in psychiatry for psychotic symptoms, 2) a DSM-IV diagnosis in the schizophrenia spectrum (or a psychotic episode suggesting a non-mood related psychosis), 3) ability to read and write in English, 4) aged between 18 and 35, 5) no organic disorder, and 6) consenting to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fraser Health Authority

Surrey, British Columbia, Canada

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Behavioral TherapyPalliative Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Tania Lecomte

    The University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2006

First Posted

August 1, 2006

Study Start

June 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

June 19, 2008

Record last verified: 2008-06

Locations

CA(1)