Treating Psychotic Symptoms of Young Individuals Presenting a First Episode of Schizophrenia: Comparison of Two State-of-the-Art Interventions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2006-12-31

Brief Summary

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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

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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

Conditions

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Schizophrenia

Keywords

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Cognitive-behavioral therapy symptom management first psychotic episode

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Cognitive-Behavioral therapy and Symptom Management

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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University of British Columbia

Principal Investigators

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Tania Lecomte

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

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Fraser Health Authority

Surrey, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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B02-0769

Identifier Type: -

Identifier Source: org_study_id