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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
50 continuous minutes, at moderate intensity (Identified by the Borg Subjective Perception of Exertion Scale, scores from 12 to 13)
CBT-I includes some therapies, including sleep restriction therapy, stimulus control therapy, sleep hygiene education, relaxation and cognitive therapy\[19\]. Traditionally, CBT-I is applied in person (individually or in a group) by a trained psychologist or psychiatrist. However, several studies show similar effects when CBT-I is performed remotely, and online (digital)
Maria Tereza
Jatai, Goiás, Brazil
RECRUITINGInsomnia Severity
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
Time frame: baseline and post-intervention (7 weeks)
Physical evaluation and Anamnesis
To evaluate the changes in the body composition (body mass, % fat and fat-free mass) of participants, a bioimpedance scale (Omron, HBF-514) will be used, with a capacity of up to 150kg. Height will be assessed by stadiometer (Sanny, Professional). The Body Mass Index (body mass/height 2) will be calculated. An anamnesis form will be used to record the participants' personal information such as age, gender, use of medications, etc
Time frame: baseline and post-intervention (7 weeks)
Cognitive and somatic arousal
To assess the level of pre-sleep cognitive and somatic arousal, the self-reported questionnaire will be used Pre-Sleep Arousal Scale (PSAS), composed of 16 items, 8 of which assess cognitive alertness and 8 assess somatic alertness. Each item has a 5-point scale that determines the intensity of the symptom experienced at the onset of sleep, with a score of 1 being no symptoms experienced and a score of 5 expressing an extremely intense symptom.
Time frame: baseline and post-intervention (7 weeks)
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess the sleep quality over the past 30 days. An overall score of 5 or less indicates good sleep quality, whereas scores greater than 5 indicate poor sleep quality.
Time frame: baseline and post-intervention (7 weeks)
Sleep Diary
The sleep diary is a method used to assess the subjective perception of sleep quality, so it should be answered in the morning upon waking. The questions contained in this questionnaire are related to bedtime and wake-up times, the number of hours of sleep, latency to sleep onset, and awakenings during the night.
Time frame: baseline and post-intervention (7 weeks)
Symptoms of anxiety, depression, and stress
Depression Anxiety Stress Scale-21 (DASS-21) will be used to evaluate anxiety, depression and stress. It is an instrument composed of a self-report scale that contains a set of three subscales type Likert of four points 0, 1, 2 and 3, where zero (strongly disagree) and three (strongly agree). Each subscale of the DASS-21 It consists of seven items. The variations in the scores correspond to the severity of the symptoms for each subscale, which vary between "normal", "minimal", "mild", "moderate", "severe and "very severe". The scores of each subscale were calculated by summing the scores of the seven items, multiplied by two.
Time frame: baseline and post-intervention (7 weeks)
Physical activity level
The short version of the International Physical Activity Questionnaire (IPAQ-SF) will be used to assess the level of physical activity of the participants, with reference to the activities of the last week. The questionnaire consists of questions regarding the frequency and duration of moderate, vigorous, and walking physical activities. Participants will be classified as insufficiently active (\<150 minutes of moderate activity/week) and active (≥150 minutes of moderate activity).
Time frame: baseline and post-intervention (7 weeks)
Sedentary Behavior
Sedentary behavior will be assessed using time spent sitting during a typical weekday and weekend. The following equation will be applied to calculate the average sitting time per day: \[(week x 5) + (weekend x 2)\] / 7. Daily sitting time classified into 3 categories (\<8 hours per day, ≥ 8 to \< 11 hours a day and ≥ 11 hours a day).
Time frame: baseline and post-intervention (7 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.