NCT05555108已完成不适用
Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in insomnia severity scores
研究概览
简要总结
The main aim of this study is to test the efficacy of a Compassive Acceptance Intervention protocol (developed by the research team) for Chronic Insomnia in comparison with the standard treatment (CBT-I).
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 (Participant)
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
- 是
入选标准
- •Insomnia Diagnosis (ICSD-3; DSM-5)
排除标准
- •Comorbidity with severe psychiatric/psychological disorder (e.g. severe depression; psychotic disorder)
- •Comorbidity with other untreated sleep disorder
- •Altered Sleep patterns due to factors different from insomnia (e.g. shift-work; pregnancy)
研究组 & 干预措施
ACTCOM-I Intervention
Experimental
干预措施: ACTCOM-I Intervention (Behavioral)
Standard CBT-I Intervention
Active Comparator
干预措施: Standard CBT-I Intervention (Behavioral)
结局指标
主要结局
Change in insomnia severity scores
时间窗: Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion
Insomnia severity assessed by the Insomnia Severity Index (ISI). The ISI is a 7-item self-report questionnaire that evaluates the nature, severity, and impact of insomnia. Scores range from 0 to 28 points with higher scores indicating more severe insomnia symptoms.
次要结局
- Change in pre-sleep arousal scores(Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion)
- Change in psychological flexibility scores(Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion)
- Change in personal values enactment scores(Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion)
- Change in dysfunctional beliefs and attitudes about sleep scores(Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion)
- Change in positive and negative affect scores(Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion)
- Change in anxiety and depression symptoms scores(Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion)
- Change in sleep effort scores(Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion)
- Change in trait mindfulness scores(Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion)
- Change in cognitive fusion scores(Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion)
- Change in Quality of life scores(Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion)
- Change in self-compassion scores(Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion)
研究者
Mariana Miller-Mendes
PhD fellowship at Center for Research in Neuropsychology and Cognitive Bebavioral Intervention (CINEICC)
University of Coimbra
研究点 (1)
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