Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia
ConditionInsomnia Chronic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade Federal de Goias
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ages ≥ 18 years old
insomnia severity index score >8
be physically inactive according to the IPAQ questionnaire
Disqualifiers
non-adherence to intervention protocols
absence or incomplete answers in the questionnaires/evaluation methods of the study
shift workers
Trial design
Design model
Parallel
Treatments tested in this trial
Aerobic Exercise
Behavioral50 continuous minutes, at moderate intensity (Identified by the Borg Subjective Perception of Exertion Scale, scores from 12 to 13)
Cognitive Behavioral Therapy for Insomnia
BehavioralCBT-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)
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Aerobic ExerciseExperimental treatment 1 intervention
Group B: Digital Cognitive Behavioral Therapy (CBT-I)Active comparator 0 interventions
Trial outcomes
Primary outcomes
1
Insomnia 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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov