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临床试验/NCT00183625
NCT00183625已完成4 期

The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2000年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
107
试验地点
2
主要终点
Total Weeks Worked

研究概览

简要总结

This study will compare employment support with behavioral skills training to employment support alone in schizophrenia patients taking either risperidone or olanzapine to determine which is more effective in helping the patients maintain a job.

详细描述

Schizophrenia is a severe mental disorder characterized by disorganized thoughts, difficulty concentrating, and hallucinations. Individuals with schizophrenia often experience reduced emotional, social, and occupational functioning. Data indicate that antipsychotic drug treatment and occupational training and support may be effective in helping people with schizophrenia maintain a stable job. Risperidone and olanzapine are antipsychotic drugs; participants in this study will be taking either risperidone or olanzapine for the duration of the study. This study will provide schizophrenia patients with employment support alone or with behavioral skills training to determine which combination is more effective in helping patients obtain and maintain a job.

At study entry, participants will undergo a clinical and diagnostic evaluation to determine the severity of their schizophrenia. Participants will be tapered off their regular medication for schizophrenia over 4 weeks. At the end of Week 4, they will be randomly assigned to receive either risperidone or olanzapine. Participants will then be assigned an Individual Placement and Support (IPS) specialist to assist them in finding a job. After participants secure a job, they will be randomly assigned to receive IPS either alone or with the Workplace Fundamentals Skills Training Module for 2 years. Participants' risperidone or olanzapine treatment will continue during this 2-year period. Participants will have clinic visits at study entry and Months 7, 12, and 24. At each visit, participants will complete questionnaires and will be interviewed about their schizophrenia symptoms and occupational functioning.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of schizophrenia
  • Candidate for maintenance schizophrenia treatment
  • Willing to initiate and continue risperidone or olanzapine therapy for the duration of the study

排除标准

  • Any serious medical problems other than schizophrenia that would interfere with the study

研究组 & 干预措施

Risperidone Plus Supported Employment

Active Comparator

干预措施: Individual Placement and Support (Supported Employment) (Behavioral)

Risperidone Plus Supported Employment

Active Comparator

干预措施: Risperidone (Drug)

Olanzapine Plus Supported Employment

Active Comparator

干预措施: Individual Placement and Support (Supported Employment) (Behavioral)

Olanzapine Plus Supported Employment

Active Comparator

干预措施: Olanzapine (Drug)

Risperidone+Supported Employment+Skills

Active Comparator

干预措施: Individual Placement and Support (Supported Employment) (Behavioral)

Risperidone+Supported Employment+Skills

Active Comparator

干预措施: Social Skills Training (Behavioral)

Risperidone+Supported Employment+Skills

Active Comparator

干预措施: Risperidone (Drug)

Olanzapine+Supported Employment+Skills

Active Comparator

干预措施: Individual Placement and Support (Supported Employment) (Behavioral)

Olanzapine+Supported Employment+Skills

Active Comparator

干预措施: Social Skills Training (Behavioral)

Olanzapine+Supported Employment+Skills

Active Comparator

干预措施: Olanzapine (Drug)

结局指标

主要结局

Total Weeks Worked

时间窗: 24 months

次要结局

  • Body Mass Index(First 18 months of study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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