NCT00885014已完成2 期
Telephone Cognitive-behavioral Therapy for Subthreshold Depression and Presenteeism in Workplace: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Depression severity as measured by Beck Depression Inventory-II (BDI2)
研究概览
简要总结
The purpose of the study is to examine the effectiveness of telephone cognitive-behavioral therapy for subthreshold depression and presenteeism in workplace, in comparison with treatment-as-usual (TAU) (which is minimal contact through Employers Assistance Program (EAP)).
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
- None
入排标准
- 年龄范围
- 20 Years 至 57 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-57 at study entry [because the retirement age is usually 60, we have to recruit the patients well before 60 in order to allow time for follow-up]
- •Men and women
- •Currently employed full-time (either regular or temporary) by the business company
- •Expected to be employed full-time for 2 years after screening
- •K6 scores greater than or equal to 9 (or 10) at screening
- •BDI2 scores greater than or equal to 10 at 2nd screening (Composite International Diagnostic Interview (CIDI) interview)
排除标准
- •Part-time employees
- •Sick leave for 6 or more days for a physical or mental condition in the past month
- •Expected to be on pregnancy leave, maternity leave or nursing leave within 2 years after screening
- •Current treatment for a mental health problem from a mental health professional
- •Major depressive episode in the past month, as ascertained by CIDI [We do not exclude dysthymia or major depression in partial remission]
- •Lifetime history of bipolar disorder, as ascertained by CIDI
- •Any substance dependence in the past 12 months, as ascertained by CIDI. [We do not exclude substance abuse.]
- •Any other current mental disorder if it constitutes the predominant aspect of the clinical presentation and requires treatment not offered in the project
- •Those who have already received the telephone CBT in the pilot runs
结局指标
主要结局
Depression severity as measured by Beck Depression Inventory-II (BDI2)
时间窗: 4 months post-randomization
Work performance as measured by the Health and Work Performance Questionnaire (HPQ) "effective hours worked" for the past month
时间窗: 4 months post-randomization
次要结局
- Client satisfaction as measured by Visual Analogue Scale (VAS)(4 months post-randomization)
- Depression severity as measured by Kessler Scale (K6)(4 months post-randomization)
- Depression severity as measured by BDI2 and K6(15 months post-randomization)
- Work performance as measured by HPQ and by job retention(15 months post-randomization)
- Client satisfaction as measured by VAS(15 months post-randomization)
- Use of EAP services and other health services(15 months post-randomization)
- Suicidal attempt and/or hospitalization (physical or mental)(15 months post-randomization)
- Time to incident major or minor depressive episode(15 months post-randomization)
研究者
Toshiaki A. Furukawa
Professor
Kyoto University
研究点 (2)
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