Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group (CBT-I) | Experimental | This group will receive 6 weeks of CBT-I treatment |
|
| Control group | No Intervention | This group will receive no treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral treatment for insomnia | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia 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. | (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass | Assessment of body mass index (BMI) To assess the patients' body weight, a bioimpedance scale (Multilaser - HC060N) will be used, with a capacity of up to 180kg. Height will be assessed using a digital portable stadiometer (Welmy). The body mass index will be calculated using the formula: body mass/height squared. | Baseline (pre-intervention) |
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giselle Soares Passos, PhD | Contact | +556436068304 | passosgs@ufg.br | |
| Tamara R.L. Zanuzzi, Master´s | Contact | tamaralima@discente.ufj.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Giselle S Passos, PhD | Federal University of Jatai | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28392168 | Background | van Straten A, van der Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee J. Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. Sleep Med Rev. 2018 Apr;38:3-16. doi: 10.1016/j.smrv.2017.02.001. Epub 2017 Feb 9. | |
| 25926368 | Background | Reis R, Teixeira F, Martins V, Sousa L, Batata L, Santos C, Moutinho J. Validation of a Portuguese version of the STOP-Bang questionnaire as a screening tool for obstructive sleep apnea: Analysis in a sleep clinic. Rev Port Pneumol (2006). 2015 Mar-Apr;21(2):61-8. doi: 10.1016/j.rppnen.2014.04.009. Epub 2015 Feb 7. |
Not provided
Not provided
The ethics committee guarantees the privacy of all participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
the statistician
| (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. | (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. | (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. | (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. | (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. | (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up. |
| Chronotype | Morningness-Eveningness Questionnaire - (MEQ) The Horne & Östberg Morningness-Eveningness Questionnaire (1976) is a psychometric instrument used to assess an individual's chronotype, that is, their preference natural for the times of day when they feel most alert, active and productive. It is used for classification of three main chronotypes, which are: morning, who prefers activities early in the day, wakes up and sleeps early, feels more alert in the morning; evening, who prefers activities at the end of the day, feels more willing at night, sleeps and wakes up later; and intermediate, who has no clear preference for morning or night. The score ranges from 16 to 86, in which scores between 16 and 41 determine the evening type, between 42 and 58 the indifferent type and between 59 and 86 defines the morning type (4). | Baseline (pre-intervention) |
| Physical activity level | International Physical Activity Questionnaire - Short Form (IPAQ-SF) The short version of the International Physical Activity Questionnaire is used to assess the level of physical activity, based on the activities of last week. The questionnaire consists of questions about the frequency and duration of moderate, vigorous and walking physical activities. The participants will be classified as insufficiently active (<150 minutes moderate activity/week) and active (>150 minutes moderate activity)(Matsudo et al., 2001). | baseline (pre-intervention) |
| Restless legs syndrome symptoms | Restless Legs Syndrome Rating Scale (IRLS) The IRLS is a scale to assess the severity of symptoms of restless legs syndrome. Restless legs syndrome is characterized by discomfort, usually in the legs, with an urgent need to move them, in the face of unpleasant sensations, which impair significantly the sufferer's sleep. The IRLS consists of 10 questions, in which the answers have a variation from 0 (corresponds to 'none') to 5 (corresponds to 'very large'). From the sum of the points of 0-10 indicates mild severity, 11 to 20 moderate, 21 to 30 severe, 31 to 40 very severe (Masuko AH et al., 2008). | Baseline (pre-intervention) |
| Sleep apnea symptoms | Stop-Bang The STOP-Bang (acronym for snoring, tiredness, observed apnea, high blood pressure, body mass index, age, neck circumference, and gender) is a self-report questionnaire that contains eight yes/no questions, used to detect obstructive sleep apnea (OSA). The scoring criteria for this questionnaire are low risk of OSA with scores of 'yes' for less than three questions and high risk for OSA with scores of 'yes' for more than three questions (Reis at al., 2015). | baseline (pre-intervention) |
| 19099121 | Background | Masuko AH, Carvalho LB, Machado MA, Morais JF, Prado LB, Prado GF. Translation and validation into the Brazilian Portuguese of the restless legs syndrome rating scale of the International Restless Legs Syndrome Study Group. Arq Neuropsiquiatr. 2008 Dec;66(4):832-6. doi: 10.1590/s0004-282x2008000600011. |
| 24238871 | Background | 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. |
| 29482814 | Background | 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. |
| 2748771 | Background | Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. |
| 22018588 | Background | Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115. |
| 1027738 | Background | Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110. |
| 11438246 | Background | Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4. |
| 7618029 | Background | Sadeh A, Hauri PJ, Kripke DF, Lavie P. The role of actigraphy in the evaluation of sleep disorders. Sleep. 1995 May;18(4):288-302. doi: 10.1093/sleep/18.4.288. |
| D001523 |
| Mental Disorders |
| D001519 | Behavior |