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临床试验/NCT06969053
NCT06969053招募中不适用

Evaluation of Mindfulness Intervention Therapy in Treating Chronic Insomnia (CI) With Comorbid Anxiety

Xuanwu Hospital, Beijing2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
2
主要终点
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This randomized controlled trial aims to investigate the efficacy of Mindfulness Intervention Therapy (MIT) in treating Chronic Insomnia (CI) comorbid with anxiety symptoms.

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
8 Years 至 —（Child, Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed with Insomnia Disorder according to DSM-5 criteria.
  • •Pittsburgh Sleep Quality Index (PSQI) total score >
  • •Age 8 years or older.
  • •Educational level of at least junior high school.
  • •Voluntarily agree to participate and provide written informed consent.
  • •Presence of anxiety symptoms, defined as Hamilton Anxiety Rating Scale (HAMA) score ≥ 14.

排除标准

  • •Presence of severe physical illnesses or major psychiatric disorders, or at risk of suicide.
  • •Diagnosed or suspected of having sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or engaged in shift work.
  • •Pregnant or breastfeeding women.
  • •Currently undergoing any psychological therapy.

结局指标

主要结局

The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks

时间窗: Baseline, 6 weeks

The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.

次要结局

  • The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months.)
  • The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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