Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aerobic Exercise, Cognitive Behavioral Therapy for Insomnia.
- Who it may be relevant to
- Registry conditions: Insomnia Chronic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia in University Students With Insomnia Complaints
Overview
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.
Interventions
- Behavioral Aerobic Exercise
50 continuous minutes, at moderate intensity (Identified by the Borg Subjective Perception of Exertion Scale, scores from 12 to 13) - Behavioral 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)
Primary outcome measures
- Insomnia Severity [Time frame: baseline and post-intervention (7 weeks)]
Secondary outcome measures (7)
- Physical evaluation and Anamnesis [Time frame: baseline and post-intervention (7 weeks)]
- Cognitive and somatic arousal [Time frame: baseline and post-intervention (7 weeks)]
- Sleep Quality [Time frame: baseline and post-intervention (7 weeks)]
- Sleep Diary [Time frame: baseline and post-intervention (7 weeks)]
- Symptoms of anxiety, depression, and stress [Time frame: baseline and post-intervention (7 weeks)]
- Physical activity level [Time frame: baseline and post-intervention (7 weeks)]
- Sedentary Behavior [Time frame: baseline and post-intervention (7 weeks)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Maria Tereza — Jatai
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. PMID 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. PMID 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. PMID 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. PMID 21145786
Identifiers
NCT: NCT06636006 · PI05992-2024