A Randomized Controlled Study of Cognitive Behavioral Therapy for Insomnia With Anxiety and Depression
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change of depressive symptoms
研究概览
简要总结
Objective to explore whether cbt-i plus is more effective and feasible for patients with insomnia complicated with anxiety and depression than the traditional cognitive behavioral therapy for insomnia.
Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.
详细描述
The purpose of this study was to explore the treatment of cognitive behavioral enhancement of insomnia (cbt-i plus), which was randomly divided into cbt-i plus intervention group (Study Group) and cbt-i intervention group (control group). The study group used the unified cognitive behavioral therapy manual for insomnia (cbt-i plus) for one-to-one individual treatment intervention, once a week, 45-50 minutes each time, a total of 8 times; the control group used the unified cognitive behavioral therapy manual for insomnia (cbt-i) for one-on-one treatment intervention, once a week, 45-50 minutes each time, a total of 8 times. The related indexes were evaluated at baseline, 2 weeks, 4 weeks and 8 weeks after enrollment, and were followed up at 12 weeks and 24 weeks after enrollment. Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.
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 (Investigator)
盲法说明
The blind method of this study is evaluator blindness, that is, the evaluator does not know the grouping of subjects.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, male and female
- •Meet the diagnostic criteria of DSM-5 for insomnia, the Pittsburgh Sleep Quality Index (PSQI) scale total score ≥10
- •May be accompanied by depression symptoms, but currently does not meet any depression disorders diagnostic criteria,14≤HAMD-17≤23
- •May be accompanied by anxiety symptoms, but currently does not meet any anxiety disorders diagnostic criteria ,14≤HAMA≤29
- •Have sufficient education and understanding to complete this study to be examined and evaluated
- •Voluntary participation in this clinical trial and signature of informed consent.
排除标准
- •DSM-5 other sleep problems, such as apnea syndrome, restless leg syndrome
- •Women who are pregnant, nursing or planning to become pregnant during the study
- •Insomnia caused by alcohol or substance abuse
- •Severe cognitive problems
- •Patients who were previously or currently diagnosed as bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, trauma and stress related disorders, separation disorders, eating disorders
- •Patients with history of epilepsy or other serious somatic diseases
- •Persons receiving MECT treatment for nearly one month
- •Excluding those who have received systemic psychotherapy for more than 3 months in a row
- •The researchers believe that it is not suitable to participate in this clinical study.
结局指标
主要结局
Change of depressive symptoms
时间窗: Change from Baseline Sleep efficiency at 8 weeks
The measurement tool is Hamilton Depression Scale-17 items,the minimum score of the scale was 0 and the maximum score was 52. The higher the score was, the more serious the depression was.
Change of anxiety symptoms
时间窗: Change from Baseline Sleep efficiency at 8 weeks
The measurement tool is Hamilton Anxiety Scale, the minimum score of the scale was 0 and the maximum score was 56. The higher the score was, the more serious the anxiety was.
Change of sleep efficiency
时间窗: Change from Baseline Sleep efficiency at 8 weeks
Sleep efficiency was measured by sleep diary Sleep efficiency was measured by sleep diary
次要结局
未报告次要终点