Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia

Universidade Federal de Goias

Status: Enrolling

Conditions: Insomnia Chronic

Treatments: Behavioral: Aerobic Exercise; Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT06636006

PI05992-2024

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Aerobic Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Aerobic Exercise

Digital Cognitive Behavioral Therapy (CBT-I)

Active Comparator group

Description:

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).