ChiCTR2100048750
Not yet recruiting
Early Phase 1
Neurobiological mechanisms underlying the effects of mindfulness-based intervention and Tai Chi Chuan on sleep disturbance in older people
General Research Fund1 site in 1 country156 target enrollmentStarted: January 1, 2022Last updated:
Overview
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- General Research Fund
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Subjective sleep quality
Overview
Brief Summary
- 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.
- To explore the lived experience of individuals in terms of sleep quality and the impact, if any, of different interventions.
- 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.
- To perform cost benefit analysis of different mind-body CAMs after collecting qualitative data from participants.
- 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.
- 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.
- To enrich the etiological model of sleep disturbance through focusing on the effects of MBI and TCC on rumination and arousal level, respectively.
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
- Masking
- None
Eligibility Criteria
- Ages
- 60 to N/A (—)
- Sex
- All
Inclusion Criteria
- •(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).
Exclusion Criteria
- •Elderly people with comorbid diagnoses of organic brain syndrome, substance misuse, psychosis, or intellectual disabilities will be excluded.
Arms & Interventions
Mindfulness-based intervention (MBI)
Mindfulness-based intervention (MBI)
Tai Chi Chuan (TCC) group
Tai Chi Chuan
Sleep hygiene education (SHE) control group
Sleep hygiene education
Outcomes
Primary Outcomes
Subjective sleep quality
Secondary Outcomes
- Objective sleep quality
- Subjective rumination
- Subjective hyperarousal
- Brain arousal level
- Frontal midline theta
Investigators
Study Sites (1)
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