CBT-I for insomnia in physically active adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares CBT-I to no treatment in physically active adults aged 30-59 with insomnia symptoms. Participants are randomly assigned to receive six weeks of CBT-I or no intervention, with outcome data collected in a confidential setting in Jataí, Goiás, Brazil. The study uses a 1:1 allocation and follows CONSORT guidelines for nonpharmacologic trials. Insomnia severity and related daytime impairment are the focus, with a sample size based on an 80% power and a 5% significance level.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tamara R. L. Zanuzzi
  Jatai, Goiás, Brazil Recruiting

Study contacts

• Principal investigator: Giselle S Passos, PhD — Federal University of Jatai
• Study coordinator: Giselle Soares Passos, PhD
• Email: passosgs@ufg.br
• Phone: +556436068304

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.