NL-OMON56549尚未招募不适用
The influence of cognitive behavioural therapy for insomnia (CBT-I) on the pathophysiology of major depressive disorder: A pilot study - The influence of CBT-I on MDD pathophysiology
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age 18 years or older.
- •- Primary diagnosis for MDD (without psychotic features) based on Diagnostic
- •and Statistical Manual 5th edition (DSM-5) criteria ascertained by the Mini
- •International Neuropsychiatric Interview (MINI).
- •- Co-morbid clinical insomnia (ISI >= 15)
- •- Stable pharmacological treatment for MDD. This pertains to all medication
- •described in the clinical guideline for the treatment of MDD including
- •antidepressant monotherapy, combination therapy (i.e., multiple antidepressants
- •provided simultaneously), and augmentation therapy (i.e., antidepressants
- •combined with lithium or atypical antipsychotics). No changes in
- •pharmacological MDD treatment (type and dosage) should be anticipated during
- •the study period or present within the four weeks prior to participation.
排除标准
- •- Comorbid diagnoses for a psychiatric disorder within one of the following
- •diagnostic groups:
- •o Bipolar disorders
- •o Schizophrenia or other psychotic disorders
- •o Delirium, dementia, and amnestic and other cognitive disorders
- •o Substance use disorder
- •- Current or recent (four weeks prior to inclusion) use of non-prescribed
- •psychoactive compounds (i.e., recreational drugs, herbal medicine etc.) not
- •including caffeine and alcohol.
- •- Pregnancy or breastfeeding.
研究者
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