The goal of this clinical trial is to learn if Cognitive Behavioral Therapy for Insomnia (CBT-I) can treat insomnia complaints in participants physically active; men and woman; aged 30-59 years old. The main question it aims to answer is: Can this terapy to reduce the insomnia severity? Can this terapy to improve sleep and related complaints? Researchers will compare CBT-I vs No treatment to see if CBT-I can promote better sleep. Participants will receive 6 weeks of treatment.
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.
This intervention is a multicomponent therapy directed to insomnia treatment. It includes sleep restriction, cognitive therapy, stimulus control, sleep higiene, and relaxation therapy (Van Straten et la., 2018)
Tamara R. L. Zanuzzi
Jatai, Goiás, Brazil
RECRUITINGInsomnia severity
The Insomnia Severity Index is a questionnaire that assesses insomnia complaints. It is a self-administered, simple and short instrument, with seven items that can be classified from 0 to 4, with the lowest final score = 0 and the highest = 28. Non-significant insomnia is considered scores from 0 to 7, lower limit for insomnia from 8 to 14, moderate insomnia from 15 to 21 and severe insomnia from 22 to 28.
Time frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.
Sleep assessment by Actigraphy
Actigraphy is a technique that allows determining the pattern of the wake-sleep cycle, through recording motor activity, resulting from body movements. This method has been considered gold standard for assessing/investigating insomnia complaints, as it provides evidence of information such as total sleep time, total wake time, latency to sleep onset and awakenings. The Micro MotionLogger® model (Ambulatory Monitoring, Inc., USA) equipment is similar to a wristwatch, which should be used for 10 consecutive days.
Time frame: (1) at baseline (pre-intervention), (2) six weeks and (3) four weeks of follow-up
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) The Pittsburg Sleep Quality Index is a questionnaire that measures the quality of sleep through seven domains that are: subjective sleep quality, sleep onset latency, duration of sleep, sleep efficiency, sleep disturbances, use of sleeping medications and daytime impairments in the last thirty days. The evaluation starts from the analysis of global scores less than or equal to 5, which suggest a good sleep quality, while scores greater than 5 suggest poor sleep quality.
Time frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.
Pré-sleep arousal
Pre-Sleep Arousal Scale (PSAS) To assess the level of Pre-Sleep cognitive and somatic alertness, the questionnaire will be used self-reported Pre-Sleep Arousal Scale (PSAS), consisting of 16 items, with eight items in the assessment of cognitive alertness and eight for somatic alertness. Each item has a five-point scale that determines the intensity of the symptom experienced at the beginning of sleep, with a score of one indicating no symptom experienced and a score of five expressing an extremely intense symptom.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Time frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.
Subjective sleep
Sleep Diary The sleep diary is a method used to assess the subjective perception of quality of sleep, so it must be answered in the morning upon waking. The questions contained in this questionnaire are related to sleep and wake times, the amount of hours of sleep, sleep onset latency of sleep and awakenings during the night. The sleep diary must be completed for a consecutive period of ten days.
Time frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.
Emotional Distress
Depression Anxiety Stress Scale-21 (DASS-21) The DASS-21 is an instrument that assesses the intensity of symptoms of depression, anxiety, and stress. It is a self-report questionnaire with twenty-one questions. Each question has a four-point Likert scale, ranging from 0 to 3. The answers are based on how the person felt in the last seven days. The raw scores are classified into levels of normal, mild, moderate, severe, and extremely severe.
Time frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.
Quality of Life
Medical Outcomes Study (SF-36) The SF-36 is a multidimensional questionnaire that covers eight components: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, vitality, general health perception, body pain, and mental health. All scores ranged from 0 to 100, with a higher score indicating better quality of life.
Time frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.