CBT-I in Physically Active Participants With Insomnia Complaints

MATERIAL AND METHODS

This is a randomized clinical trial with two parallel groups, conducted in the period from November 2025 to April 2029, in the municipality of Jataí, located in the interior of Goiás, region Midwest of Brazil. Data collection will be carried out in a private room environment, to guarantee secrecy and confidentiality of the participants' information, as well as their accommodation. All participants in the study will be identified by codes, to guarantee secrecy and confidentiality of information from participants

Sample selection Patients of the male and female gender will be selected, physically active (practice of physical exercise \>150 min/week) with complaints of insomnia, who will be randomly distributed into two groups: control group (without interventions) and intervention group with CBT-I. The selected participants will be randomly distributed with an allocation rate of 1:1, according to the standards of the Consolidated of Reporting Trials (CONSORT) for Randomized Trials of Nonpharmacologic Treatments. Randomization will be carried out by an external automated online system, ensuring that the allocation is not influenced by the research team.

The selected participants will be randomly distributed (simple randomization 1:1).. The sample size was calculated considering a significance level of 5% (p=0.05), test power of 80%, difference of 4 points in the mean of the Insomnia Severity Index (ISI), and average standard deviation (sigma) of 5.0. Control group (n=25) and CBT-I Group (n=25).

The schedule of activities with the intervention and control groups will occur for a total period of up to 13 weeks. Assessments will be carried out at three different times: (1) at baseline (pre-intervention), (2) after six weeks and (3) after four weeks of follow-up.

Ethical considerations The study was approved from the Research Ethics Committee of the Federal University of Jataí (CAAE: 94602225.8.0000.0187). Participants must sign the Free and Informed Consent Form. All material from the study will be the responsibility of the researcher responsible and stored for a period of five years, then incinerated.

This research follows the ethical principles for medical research on human beings outlined in the Helsinki Declaration, contemplating the norms established by Resolution 466/2012 (1)of the National Health Council, making use of the principles of autonomy, beneficence, non-maleficence and justice. All necessary measures will be taken to guarantee the integrity, privacy and well-being of the participants during all stages of the study.

Only participants who sign the Free and Informed Consent Form will participate in the research Clarified, which must comprise the first session of the research form, whose signature for agreement will be recorded on the form itself by filling in the full name of the participant. The autonomy of the participants to answer, or not, the research will be ensured, as well as the guarantee of confidentiality and anonymity, in addition to the presentation of the risks and benefits arising from their participation. Any damage demonstrably caused by the research will be repaired in accordance with the Resolution CNS nº 466/12(1).

The consent form guarantees the right to clarify the research, withdrawal at any time from participating in the research, without any prejudice, guarantee of privacy and confidentiality, in addition to compensation for any damage resulting from the research and reimbursement of expenses arising from participation in the study.

Study design This is a randomized clinical trial with two parallel groups, conducted in the period from November 2025 to December 2028, in the municipality of Jataí, located in the interior of Goiás, Midwest region of Brazil. The protocol will be registered in the Clinicaltrials.com database.

Participants will be recruited voluntarily through advertising and leaflets in gyms in the city of Jataí-Goiás and on the official website of the Federal University of Jataí. Through contact via telephone (WhatsApp) or e-mail, the participant must fill out a registration form. Then, through a face-to-face interview, in a well-lit, air-conditioned room, free of distractions, with suitable and comfortable furniture for privacy, on the premises of Clínica Neso, located at Tiradentes N. 2567, in the city of Jataí-Goiás, volunteers will receive guidance on their search procedures and signing of the informed consent form and registration form. Volunteers interested in participating in the research will be submitted to a sequence of assessments, which aim to ensure the inclusion criteria and exclusion of this study. Included participants will be submitted to assessments on health and sleep conditions through self-applicable questionnaires and sleep assessment through actigraphy. In addition, they will also be questionnaires applied that assess frequency and duration of physical activity; chronotype of morningness and eveningness; level of cognitive and somatic alertness in pre-sleep; dysfunctional beliefs and attitudes about sleep; mood changes, depression, anxiety and stress; quality of life; sleep hygiene index; risk of obstructive sleep apnea; risk of restless legs syndrome symptoms; and body mass index.

• Sleep assessment by Actigraphy [Time frame: (1) at baseline (pre-intervention), (2) six weeks and (3) four weeks of follow-up]
• Sleep quality [Time frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.]
• Pré-sleep arousal [Time frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.]
• Subjective sleep [Time frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.]
• Emotional Distress [Time frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.]
• Quality of Life [Time frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.]