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Insomnia ChronicNCT06636006

Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia

A study testing Aerobic Exercise and Cognitive Behavioral Therapy for Insomnia in people with Insomnia Chronic, run by Universidade Federal de Goias at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Insomnia Chronic
What is being tested?
Aerobic Exercise and Cognitive Behavioral Therapy for Insomnia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteBrazil
Study dates
10 Oct 2024to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ages ≥ 18 years old
  • insomnia severity index score >8
  • be physically inactive according to the IPAQ questionnaire

Who cannot join

  • non-adherence to intervention protocols
  • absence or incomplete answers in the questionnaires/evaluation methods of the study
  • shift workers

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Giselle Soares Passos, PhD contact

+55 064 981036150

passos.gs@gmail.com

Brazil1 site, 1 recruiting

  • Maria Tereza

    Jatai, Goiás, 75801-615

    Maria Tereza Vidigal, Master Degree Student, +55 64 992220588, mariatereza.vidigal@gmail.com

    Renata Bolzan (Graduate Student)

    Recruiting

Other trials in Brazil

About this study

Official title: Effects of Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia in University Students With Insomnia Complaints

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.

Being tested
Aerobic Exercise, Cognitive Behavioral Therapy for Insomnia
Keywords
chronic insomnia, exercise, sleep, anxiety, depression
Medical subject headings
Sleep Initiation and Maintenance Disorders, Motor Activity, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic ExerciseBehavioural

    50 continuous minutes, at moderate intensity (Identified by the Borg Subjective Perception of Exertion Scale, scores from 12 to 13)

  • Cognitive Behavioral Therapy for InsomniaBehavioural

    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)

Study groups in NCT06636006
Study groupRoleWhat they receive
Aerobic ExerciseExperimentalThree 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.
Receives: Behavioral: Aerobic Exercise
Digital Cognitive Behavioral Therapy (CBT-I)Active comparatorThree 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline and post-intervention (7 weeks)

Secondary outcomes (7)

  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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: baseline and post-intervention (7 weeks)

  5. 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.

    Measured: baseline and post-intervention (7 weeks)

  6. 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).

    Measured: baseline and post-intervention (7 weeks)

  7. 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).

    Measured: baseline and post-intervention (7 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2024
  2. Study start10 Oct 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06636006
Sponsor's protocol ID
PI05992-2024
Status last verified
Apr 2026
First submitted
8 Oct 2024
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vignola RC, Tucci AM. Adaptation and validation of the depression, anxiety and stress scale (DASS) to Brazilian Portuguese. J Affect Disord. 2014 Feb;155:104-9. doi: 10.1016/j.jad.2013.10.031. Epub 2013 Oct 28.

    PubMed 24238871

  • Rosenberg DE, Bull FC, Marshall AL, Sallis JF, Bauman AE. Assessment of sedentary behavior with the International Physical Activity Questionnaire. J Phys Act Health. 2008;5 Suppl 1:S30-44. doi: 10.1123/jpah.5.s1.s30.

    PubMed 18364524

  • Matsudo, S., Araújo, T., Matsudo, V., Andrade, D., Andrade, E., Oliveira, L. C., Braggion, G. International Physical Activity Questionnaire (IPAQ): Validity and reproducibility study in Brazil. . Brazilian Journal of Physical Activity and Health. 2001,5:5-18.

  • Ruivo Marques D, Allen Gomes A, Nicassio PM, Azevedo MHP. Pre-Sleep Arousal Scale (PSAS): psychometric study of a European Portuguese version. Sleep Med. 2018 Mar;43:60-65. doi: 10.1016/j.sleep.2017.10.014. Epub 2017 Dec 19.

    PubMed 29482814

  • Bertolazi AN, Fagondes SC, Hoff LS, Dartora EG, Miozzo IC, de Barba ME, Barreto SS. Validation of the Brazilian Portuguese version of the Pittsburgh Sleep Quality Index. Sleep Med. 2011 Jan;12(1):70-5. doi: 10.1016/j.sleep.2010.04.020. Epub 2010 Dec 9.

    PubMed 21145786

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Exercise and Cognitive Behavioral Therapy for Insomnia in people with Insomnia Chronic, run by Universidade Federal de Goias at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giselle Soares Passos, PhD (+55 064 981036150, passos.gs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insomnia Severity (time frame: baseline and post-intervention (7 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06636006, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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