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临床试验/ChiCTR2100048750
ChiCTR2100048750尚未招募Unknown

Neurobiological mechanisms underlying the effects of mindfulness-based intervention and Tai Chi Chuan on sleep disturbance in older people

General Research Fund1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2022年1月1日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
156
试验地点
1
主要终点
Subjective sleep quality

研究概览

简要总结

  1. To provide novel insight into the additive and synergistic effects of an mindfulness-based intervention (MBI) group and a Tai Chi Chuan (TCC) group for sleep disturbance in older people over a 12-month follow-up period by comparison to a sleep hygiene education (SHE) control group.
  2. To explore the lived experience of individuals in terms of sleep quality and the impact, if any, of different interventions.
  3. To provide empirical support to guide clinical practice regarding the judicious use and feasibility of different types of mind-body-based complementary and alternative medicine (CAM) for sleep problems in the elderly population.
  4. To perform cost benefit analysis of different mind-body CAMs after collecting qualitative data from participants.
  5. To examine the mediating roles of salivary cortisol and brain-derived neurotrophic factor (BDNF) as biological mechanisms underlying the potential beneficial effects of MBI and TCC on sleep quality, respectively.
  6. To examine the mediating roles of frontal midline theta and brain arousal level as neurological mechanisms underlying the anticipated beneficial effects of MBI and TCC on sleep quality, respectively.
  7. To enrich the etiological model of sleep disturbance through focusing on the effects of MBI and TCC on rumination and arousal level, respectively.

研究设计

研究类型
Interventional
主要目的
随机平行对照
盲法
None

入排标准

年龄范围
60 至 —(—)
性别
All

入选标准

  • (1) aged 60 years or above;
  • (2) classified as experiencing sleep disturbances (poor sleep quality indicated by a score >5 on the PSQI (Tsai et al., 2005));
  • (3) primary education level or above and able to communicate in Cantonese;
  • (4) able to give informed consent;
  • (5) no previous experience with meditation or other mind-body techniques (e.g., Tai Chi or yoga).

排除标准

  • Elderly people with comorbid diagnoses of organic brain syndrome, substance misuse, psychosis, or intellectual disabilities will be excluded.

研究组 & 干预措施

Tai Chi Chuan (TCC) group

Tai Chi Chuan

Mindfulness-based intervention (MBI)

Mindfulness-based intervention (MBI)

Sleep hygiene education (SHE) control group

Sleep hygiene education

结局指标

主要结局

Subjective sleep quality

次要结局

  • Objective sleep quality
  • Subjective rumination
  • Subjective hyperarousal
  • Brain arousal level
  • Frontal midline theta

研究者

发起方
General Research Fund

研究点 (1)

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