NCT06636006

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Oct 2024Dec 2027

First Submitted

Initial submission to the registry

October 8, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

October 8, 2024

Last Update Submit

April 23, 2026

Conditions

Insomnia Chronic

Keywords

chronic insomniaexercisesleepanxietydepression

Outcome Measures

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

    baseline and post-intervention (7 weeks)

Secondary Outcomes (7)

  • Physical evaluation and Anamnesis

    baseline and post-intervention (7 weeks)

  • Cognitive and somatic arousal

    baseline and post-intervention (7 weeks)

  • Sleep Quality

    baseline and post-intervention (7 weeks)

  • Sleep Diary

    baseline and post-intervention (7 weeks)

  • Symptoms of anxiety, depression, and stress

    baseline and post-intervention (7 weeks)

  • +2 more secondary outcomes

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

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.

Behavioral: Aerobic Exercise

Digital Cognitive Behavioral Therapy (CBT-I)

ACTIVE COMPARATOR

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).

Interventions

Aerobic ExerciseBEHAVIORAL

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

Aerobic Exercise
Cognitive Behavioral Therapy for InsomniaBEHAVIORAL

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

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Tereza

Jatai, Goiás, 75801-615, Brazil

RECRUITING

Related Publications (5)

  • 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: 24238871RESULT

  • 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: 18364524RESULT

  • 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.

    RESULT

  • 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: 29482814RESULT

  • 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: 21145786RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersMotor ActivityAnxiety DisordersDepression

Interventions

ExerciseCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Giselle Soares Passos, PhD

CONTACT

+55 064 981036150passos.gs@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 10, 2024

Study Start

October 10, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)