CBT-I in Physically Active Participants With Insomnia Complaints

May 26, 2026 updated by: Giselle Soares Passos, Federal University of Jatai

Effects of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Physically Active Participants With Insomnia Complaints: a Randomized Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Giselle Soares Passos, PhD
  • Phone Number: +556436068304
  • Email: passosgs@ufg.br

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Age range between 30-59 years;
  • Practice regular physical exercise for over 150 minutes per week;
  • Complaints of insomnia (difficulty initiating and/or maintaining sleep and/or early awakening) more than three times a week, for at least three months, associated with complaints of daytime impairments (occupational, academic or social) related to insomnia;
  • Insomnia severity index greater than fifteen (>15).

Exclusion criteria:

  • Shift workers;
  • Evidence that insomnia is associated with restless legs syndrome;
  • Evidence that insomnia is associated with medication side effects;
  • Evidence that insomnia is associated with signs or symptoms of mental disorders;
  • Abusive use of alcohol or illicit psychoactive substances.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group (CBT-I)
This group will receive 6 weeks of CBT-I treatment
Behavioral: Cognitive behavioral treatment for insomnia
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)
No Intervention: Control group
This group will receive no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia severity
Time Frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep assessment by Actigraphy
Time Frame: (1) at baseline (pre-intervention), (2) six weeks and (3) four weeks of follow-up
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.
(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.
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
Time Frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.
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
Time Frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.
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
Time Frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.
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
Time Frame: (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass
Time Frame: Baseline (pre-intervention)
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)
Chronotype
Time Frame: Baseline (pre-intervention)
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
Time Frame: baseline (pre-intervention)
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
Time Frame: Baseline (pre-intervention)
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
Time Frame: baseline (pre-intervention)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Jatai

Investigators

  • Principal Investigator: Giselle S Passos, PhD, Federal University of Jatai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 94602225.8.0000.0187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The ethics committee guarantees the privacy of all participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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