Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia
NCT ID: NCT06636006
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-10-10
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Aerobic Exercise
50 continuous minutes, at moderate intensity (Identified by the Borg Subjective Perception of Exertion Scale, scores from 12 to 13)
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).
No interventions assigned to this group
Interventions
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Aerobic Exercise
50 continuous minutes, at moderate intensity (Identified by the Borg Subjective Perception of Exertion Scale, scores from 12 to 13)
Cognitive Behavioral Therapy for Insomnia
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)
Eligibility Criteria
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Inclusion Criteria
* insomnia severity index score \>8
* be physically inactive according to the IPAQ questionnaire
Exclusion Criteria
* absence or incomplete answers in the questionnaires/evaluation methods of the study
* shift workers
18 Years
ALL
No
Sponsors
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Universidade Federal de Goias
OTHER
Responsible Party
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Giselle Soares Passos
Associate professor
Locations
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Maria Tereza
Jatai, Goiás, Brazil
Countries
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Central Contacts
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Facility Contacts
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Renata Bolzan (Graduate Student)
Role: backup
References
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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.
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.
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.
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.
Other Identifiers
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PI05992-2024
Identifier Type: -
Identifier Source: org_study_id
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