Treating Psychotic Symptoms of Young Individuals Presenting a First Episode of Schizophrenia: Comparison of Two State-of-the-Art Interventions
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Cognitive-Behavioral therapy and Symptom Management
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Cognitive-behavioral therapy, symptom management, first psychotic episode
Eligibility Criteria
Inclusion Criteria: 1) 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 Exclusion Criteria: -
Sites / Locations
- Fraser Health Authority
Outcomes
Primary Outcome Measures
Expected effects on symptoms, measured before beginning of treatment, three months, nine-months, and 15-months follow-ups
Secondary Outcome Measures
Self-esteem, social adaptation, coping, insight, substance abuse, measured before beginning treatment, three months, nine-months, and 15-months follow-ups
Full Information
NCT ID
NCT00358709
First Posted
July 28, 2006
Last Updated
June 18, 2008
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00358709
Brief Title
Treating Psychotic Symptoms of Young Individuals Presenting a First Episode of Schizophrenia: Comparison of Two State-of-the-Art Interventions
Official Title
Treating Psychotic Symptoms of Young Individuals Presenting a First Episode of Schizophrenia: Comparison of Cognitive-Behavioral Therapy and Skills Training Symptom Management on Measures of Symptoms and on Other Indices of Well-Being
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of British Columbia
4. Oversight
5. Study Description
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
Detailed Description
The study's protocol has the following objectives: to verify the efficacy of a group CBT approach; to compare the effects of CBT to those of the symptom management module and to a control group on psychotic symptoms and subjective experiences (e.g., depression, anxiety, self-esteem, social support, insight, and coping); and to assess what the effects are related to, via measuring client variables, therapist variables, and intervention variables that might explain the results. This study follows a randomized controlled trial design where participants are randomly assigned to one of the three groups at each recruiting wave. Both treatment modalities hold the same number of group meetings as well as similar formats, lengths of treatment and operational structures, each operationalized in detailed manuals. Interviewers are blind to group allocation. Symptoms, both psychotic and otherwise, depression, self-esteem, social adaptation, anxiety, insight, social support, and coping are all measured before the beginning of treatment, three months follow-up, nine-months follow-up, and 15-months follow-up
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Cognitive-behavioral therapy, symptom management, first psychotic episode
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
129 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral therapy and Symptom Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Expected effects on symptoms, measured before beginning of treatment, three months, nine-months, and 15-months follow-ups
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Self-esteem, social adaptation, coping, insight, substance abuse, measured before beginning treatment, three months, nine-months, and 15-months follow-ups
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) 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
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania Lecomte
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fraser Health Authority
City
Surrey
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Treating Psychotic Symptoms of Young Individuals Presenting a First Episode of Schizophrenia: Comparison of Two State-of-the-Art Interventions
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