Integrated Cognitive Behavior Therapy to Improve Work Outcomes in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Workforce Participation Measure - Total Number of Jobs Attained
研究概览
简要总结
Schizophrenia/Schizoaffective Disorder is associated with serious problems with cognitive skills, social skills, and functional skills (like employment). There is a new form of cognitive behavioral therapy called integrated cognitive behavioral therapy (iCBT) that specifically addresses the cognitive, social, and functional deficits of schizophrenia/schizoaffective disorder. This study compared iCBT to the usual care (UC) that Veteran's receive. The investigators compared iCBT to UC in subjects with schizophrenia/schizoaffective disorder who are enrolled in a Supported Employment (SE) program, and evaluate whether iCBT is more helpful in improving job attainment, and other areas of functioning, both right after treatment, and 6 months after the end of treatment.
详细描述
The objective of the current study was to evaluate whether integrated cognitive behavior therapy (iCBT) can improve engagement and success in an existing Supported Employment (SE) program among the most functionally disabled patients with schizophrenia/schizoaffective disorder. The iCBT condition also included computerized cognitive remediation. The primary specific aim was to determine whether iCBT will significantly improve work outcomes at post-treatment to a greater extent than Usual Care (UC) in low functioning patients with schizophrenia/schizoaffective disorder who join the SE program. The secondary aims were to evaluate the whether iCBT will significantly improve work outcomes at 6 month follow-up relative to UC, and whether iCBT will improve functional outcomes post-treatment and at follow-up relative to UC in subjects who join the SE program.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of DSM-IV schizophrenia or schizoaffective disorder (SCID)
- •Severe/extreme functional disability [World Health Organization Disability Assessment Scale (WHODAS) score > 50]
- •Clinical stability (as per primary mental health provider)
- •Receiving treatment at the Veterans Administration
- •Minimal engagement in psychiatric rehabilitation services (just psychiatrist and therapist/case management in the last 6 months)
- •Eligible for and willing to be enrolled in Supported Employment program
- •Age 18 to 65
- •Proficient in English
- •Able to give informed consent
排除标准
- •Neurologic disease or damage that would make the diagnosis of schizophrenia questionable
- •Current opioid or stimulant dependence (SCID)
- •Not appropriate due to safety concerns (based on risk assessment)
结局指标
主要结局
Workforce Participation Measure - Total Number of Jobs Attained
时间窗: Baseline to post-treatment (18-months)
Measure completed by the support employment specialist that evaluates participation in the workforce: Total number of jobs attained per group across the full length of the study (Baseline to 18 month follow-up, study end)
Overall Job Attainment Proportion
时间窗: Study start through 18 months of the active portion of the study.
This is the proportion of participants, by group, that attained at least one job during the active portion of the study.
Job Participant Composite-hours Worked
时间窗: Baseline to study intervention start point (ranging from 1-10 months), then at 6 months after intervention start, 12 months after intervention start, and then 18 months after intervention start.
This is a composite of hours work per week X number of weeks worked, in each assessment period.
次要结局
- Work Behavior Inventory(Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months))
- Specific Levels of Functioning (SLOF)(Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months))