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OpenTrials
Completed

NCT Number: NCT00358709

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

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

Completed

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fraser Health Authority

Surrey, British Columbia, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

-

Treatment and study plan

Cognitive-Behavioral therapy and Symptom Management

Behavioral

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 outcomes

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

    Time frame: 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

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Aug 1, 2006
Registry last updated
Jun 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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