跳至主要内容
临床试验/NCT00358709
NCT00358709已完成3 期

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

University of British Columbia1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2002年6月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
129
试验地点
1
主要终点
Expected effects on symptoms, measured before beginning of treatment, three months, nine-months, and 15-months follow-ups

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 15 months

次要结局

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

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验