Clinical trial NCT06636006: Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia
Official title: Effects of Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia in University Students with Insomnia Complaints
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia Chronic
Keywords: chronic insomnia
exercise
sleep
anxiety
depression
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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: Inclusion Criteria:

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

Exclusion criteria:

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

Primary outcomes:
measure: Insomnia Severity
timeFrame: baseline and post-intervention (7 weeks)
Secondary outcomes:
measure: Physical evaluation and Anamnesis
timeFrame: baseline and post-intervention (7 weeks)
measure: Cognitive and somatic arousal
timeFrame: baseline and post-intervention (7 weeks)
measure: Sleep Quality
timeFrame: baseline and post-intervention (7 weeks)
measure: Sleep Diary
timeFrame: baseline and post-intervention (7 weeks)
measure: Symptoms of anxiety, depression, and stress
timeFrame: baseline and post-intervention (7 weeks)
measure: Physical activity level
timeFrame: baseline and post-intervention (7 weeks)
measure: Sedentary Behavior
timeFrame: baseline and post-intervention (7 weeks)
Other outcomes:
Locations:
city: Jataí
country: Brazil
facility: Maria Tereza
state: GO
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.