CBT-I in Physically Active Participants With Insomnia Complaints

NCT07607444 | Not Yet Recruiting

• 1 other identifier: CAAE: 94602225.8.0000.0187
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Insomnia

Keywords

insomnia; cognitive behavioral therapy; physical activity

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• Sleep assessment by Actigraphy

  (1) at baseline (pre-intervention), (2) six weeks and (3) four weeks of follow-up

• Sleep quality

  (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.

• Pré-sleep arousal

  (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.

• Subjective sleep

  (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.

• Emotional Distress

  (1) at baseline (pre-intervention), (2) six weeks, and (3) four weeks of follow-up.

Other Outcomes (5)

• Body mass

  Baseline (pre-intervention)

• Chronotype

  Baseline (pre-intervention)

• Physical activity level

  baseline (pre-intervention)

Study Arms (2)

Treatment group (CBT-I)

EXPERIMENTAL

This group will receive 6 weeks of CBT-I treatment

Behavioral: Cognitive behavioral treatment for insomnia

Control group

NO INTERVENTION

This group will receive no treatment

Interventions

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)

Treatment group (CBT-I)

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Jatai: lead

Related Publications (10)

• 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.

  PMID: 28392168 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.

  PMID: 25926368 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.

  PMID: 19099121 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.

  PMID: 24238871 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.

  PMID: 29482814 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.

  PMID: 2748771 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.

  PMID: 22018588 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.

  PMID: 1027738 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.

  PMID: 11438246 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.

  PMID: 7618029 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Study Officials

• Giselle S Passos, PhD

  Federal University of Jatai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giselle Soares Passos, PhD

CONTACT

+556436068304; passosgs@ufg.br

Tamara R.L. Zanuzzi, Master´s

CONTACT

tamaralima@discente.ufj.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 30, 2029
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share