Brisk Walking Training Compared with Cognitive Behavioral Therapy for the Treatment of Chronic Primary Insomnia in People Aged 60 Years or Above: a Randomized, Partially Blinded, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Score of the Insomnia Severity Index (ISI)
研究概览
简要总结
This study is a single-blinded (outcome assessor) and parallel-group non-inferiority RCT. Chinese older adults aged ≥60 years with chronic primary insomnia will be randomized evenly (1:1) to either the brisk walking training group or the CBT-I group. Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week). Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week). Self-reported and objective sleep outcomes are measured at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3).
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
- •Aged ≥60 years;
- •Ethnic Chinese; able to read, write and speak Cantonese
- •Having a Hong Kong ID;
- •Willing to wear an accelerometer on the wrist for a week to assess sleep parameters at T0, T1, and T
- •Score ≥10 in the Insomnia Severity Index (ISI) (presence of insomnia)
- •Experiencing any one of the following symptoms for ≥3 days per week
- •Difficulty initiating sleep; OR
- •Difficulty maintaining sleep; OR
- •Early-morning awakening with inability to return to sleep
排除标准
- •Score ≥1 in the Chinese version of the Physical Activity Readiness Questionnaire (PAR-Q);
- •Currently regularly practicing a moderate-intensity PA program such as brisk walking or Tai Chi (≥3 times a week, ≥30 minutes/session);
- •Currently receiving or scheduled to receive CBT-I during the study period;
- •Score ≤16 in the validated telephone version of the Cantonese Mini-Mental State Examination (T-CMMSE).
- •Working nightshifts and unable/unwilling to discontinue such work pattern;
- •Having a diagnosis of a major depressive disorder, anxiety disorders or other severe mental disorder (bipolar disorders, psychosis). Those with mild depression or anxiety disorders will not be excluded;
- •Use of antidepressant or antipsychotic medication or under treatment of other serious diseases (e.g., cancer chemotherapy) known to affect sleep;
- •Presence of any serious chronic diseases which affect sleep (e.g., cancer, autoimmune diseases).
- •Having a serious somatic condition preventing the participation of brisk walking training/CBT-I.
研究组 & 干预措施
Brisk walking group
Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week).
干预措施: Brisk walking (Behavioral)
CBT-I group
Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week).
干预措施: Cognitive-behavioral therapy for insomnia (Behavioral)
结局指标
主要结局
Score of the Insomnia Severity Index (ISI)
时间窗: 12 months
Score of the Insomnia Severity Index (ISI) measured at at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3).
次要结局
- Insomnia remission(12 months)
- Sleep quality(12 months)
- Seven-day ActiGraph(12 months)
研究者
Zixin Wang
Assistant Professor
Chinese University of Hong Kong