NCT05482646已完成不适用
Tai Chi Versus Conventional Exercise to Alleviate Depressive Symptoms in Older Insomniacs: A Three-arm Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Hospital Anxiety and Depression Scale - Depression
研究概览
简要总结
This study aims to examine the effectiveness of Tai Chi and conventional exercise in alleviating depressive symptoms in older insomniacs.
详细描述
Chinese community-dwelling older adults with mild-to-moderate depressive symptoms and chronic insomnia will be recruited.
Eligible participants will be randomized to health education control, Tai Chi or conventional exercise interventions on a 1:1:1 basis after baseline assessment.
All interventions will last for 3 months. Outcomes will be assessed at baseline, at 3 months and at 6 months after the completion of the intervention.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 years or older
- •Can communicate using Cantonese or Mandarin
- •with mild-to-moderate depressive symptoms (HADS-depression score ≥8/21 and PHQ- 9 score ≤14/27)
- •Fulfil the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for chronic insomnia including difficulties in initiating or maintaining sleep, early morning awakening with complaint of significant distress or impairment of daytime functioning, sleep difficulty occurring at least three nights per week and present for at least 3 months.
排除标准
- •Somatic condition that prevents participation in tai chi or exercise
- •Regular moderate-to-vigorous intensity exercise or mind-body training such as tai chi, yoga, qigong or meditation in the past 3 months
- •Any form (or combination) of exercises amounting to 180 minutes per week in the past 3 months
- •Diagnosis with schizophrenia or other psychotic disorders, bipolar disorders or alcohol/substance use/abuse
- •Current usage or planning to use potentially confounding treatments, including herbal supplementations (e.g., St. John's Wort), acupuncture treatment, cognitive behavioral therapy or other psychotherapy, mind-body intervention (e.g., mindfulness training and muscle relaxation training) or muscle relaxants such as carisoprodol, cyclobenzaprine, diazepam
- •Current suicidal or self-injurious potential that requires immediate clinical follow-up.
结局指标
主要结局
Hospital Anxiety and Depression Scale - Depression
时间窗: 9 months (6 months post-intervention follow-up)
The depression score of the Hospital Anxiety and Depression Scale (HADS-D) will be used to evaluate the severity of depressive symptoms. This consists of a seven-item questionnaire with an overall score ranging from 0 to 21. Higher scores are indicative of more severe depressive symptoms.
次要结局
- Insomnia severity index(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Patient Health Questionnaire(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Pittsburgh Sleep Quality Index(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Medication usage(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Sleep efficiency through sleep diary(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Wake time after sleep onset through actigraph(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Number of awakenings through sleep diary(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Sleep onset latency through actigraph(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Average awake time through actigraph(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Number of awakenings through actigraph(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Average awake time through sleep diary(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Total sleep time through actigraph(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Total sleep time through sleep diary(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- General Anxiety Disorder Scale(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- The 12-item Short Form Survey(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Hospital Anxiety and Depression Scale - Anxiety(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Short Physical Performance Battery(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Sleep efficiency through actigraph(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Wake time after sleep onset through sleep diary(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
- Sleep onset latency through sleep diary(3 months (post-intervention) and 9 months (6 months post-intervention follow-up))
研究者
Parco M. Siu, PhD
Associate Professor
The University of Hong Kong
研究点 (1)
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