Effects of Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia in University Students With Insomnia Complaints
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Insomnia Severity
研究概览
简要总结
The purpose of this study is to compare the effects of aerobic exercise versus digital CBT-I in university students with insomnia complaints. This is a clinical trial. Participants will be randomized into two groups: aerobic exercise (n=25) and digital CBT-I (n=25). The severity of insomnia, sleep quality, pre-sleep cognitive and somatic arousal, and participants' complaints of depression, anxiety, and stress will be assessed using self-administered questionnaires. Based on previous studies describing the effects of physical exercise on chronic insomnia, the hypothesis of this study is that aerobic exercise promotes similar results compared to digital CBT-I in insomnia severity and sleep quality, in addition to improving the complaints of depression, anxiety and stress of the participants.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages ≥ 18 years old
- •insomnia severity index score >8
- •be physically inactive according to the IPAQ questionnaire
排除标准
- •non-adherence to intervention protocols
- •absence or incomplete answers in the questionnaires/evaluation methods of the study
- •shift workers
研究组 & 干预措施
Aerobic Exercise
Three sessions of aerobic exercise per week (outdoor walking), for 50 continuous minutes, at moderate intensity (Identified by the Borg Subjective Perception of Exertion Scale, scores from 12 to 13), will be performed for 7 weeks. These sessions will be accompanied by a researcher responsible for data collection, who will make a daily record of the activities. The practice time will be between 5:00 pm and 7:00 pm.
干预措施: Aerobic Exercise (Behavioral)
Digital Cognitive Behavioral Therapy (CBT-I)
Three weekly sessions of digital CBT-I will be held through the Vigilantes do Sono® application (digital therapy with the therapeutic protocol approved by ANVISA, Brazil).
结局指标
主要结局
Insomnia Severity
时间窗: baseline and post-intervention (7 weeks)
The severity of insomnia will be assessed using the Insomnia Severity Index (ISI) questionnaire. This instrument was developed to assess insomnia complaints. It is a self-administering, brief and simple scale, composed of 7 items that can be classified from 0 to 4, with the lowest final score = 0 and the highest = 28. Scores from 0 to 7 are considered non-significant insomnia, lower limit for insomnia from 8 to 14, moderate insomnia from 15 to 21, and severe insomnia from 22 to 28
次要结局
- Physical evaluation and Anamnesis(baseline and post-intervention (7 weeks))
- Cognitive and somatic arousal(baseline and post-intervention (7 weeks))
- Sleep Quality(baseline and post-intervention (7 weeks))
- Sleep Diary(baseline and post-intervention (7 weeks))
- Symptoms of anxiety, depression, and stress(baseline and post-intervention (7 weeks))
- Physical activity level(baseline and post-intervention (7 weeks))
- Sedentary Behavior(baseline and post-intervention (7 weeks))
研究者
Giselle Soares Passos
Associate professor
Universidade Federal de Goias