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Study of Cognitive Behavioral Therapy for Insomnia (CBT-I)

This study is looking at how Cognitive Behavioral Therapy for Insomnia (CBT-I) helps improve sleep and daily well-being for people with chronic insomnia. CBT-I is a common treatment that teaches you tools to improve your sleep. Researchers want to understand how CBT-I affects your body's stress response system (called the HPA axis, which involves cortisol levels). They will measure your insomnia symptoms, how well you sleep through the night (sleep continuity), and your total sleep time. You may be able to join if you are at least 18 years old, speak English, and have chronic insomnia. The study is currently unclear on its status and plans to enroll 115 participants.

Study design
This is an interventional study planning to enroll 115 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will receive weekly CBT-I sessions. Measurements will be taken at the start, before treatment, after treatment, and at the end of the study, which can last up to 7 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment through study completion, which can be up to 7 months depending on the assigned treatment group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07156383

Restorative Effects of Sleep on Everyday Health and Wellbeing: A Treatment Study

Recruiting
NAAges 18+InterventionalTreatment
University of Notre Dame
~115 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:Cognitive Behavioral Therapy for Insomnia

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insomnia Symptoms
Measured over From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).
+3 more outcomes measured

Conditions

Chronic Insomnia

Explore related trials

Insomnia

Where it's being run

1 sites across 1 states
Indiana1

Who to contact

Ivan Vargas
[email protected]
574-631-5914
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

At least 18-years-old
Speaks English
Meets DSM-5 criteria for Insomnia Disorder, determined through initial screener than verified during brief clinical interview (at intake)

Exclusion

Sleep disorders other than Insomnia
Endocrine disorders
Extreme sleep schedule (i.e. shift workers)
Currently taking sleep medication
Currently taking medication for endocrine dysfunction
Currently taking medication that interferes with sleep or cortisol levels
Excessive alcohol/substance use or AUD/SUD
Serious mental illness
Chronic medical conditions (which may be exacerbated by sleep restriction)
Pregnant or nursing women
Women in the peri-menopausal stage due to irregular menses and fluctuations in sex hormones.

What this trial measures

  • Insomnia SymptomsFrom enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).

    Total score on the Insomnia Severity Index (ISI), which ranges from 0-28. Higher scores indicate greater insomnia severity, while lower scores indicate less insomnia severity.

  • Sleep Continuity DisturbanceFrom enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).

    Mean sleep latency, wake after sleep onset, and early morning awakenings (in minutes assessed via daily sleep diaries).

  • Total Sleep TimeFrom enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).

    Mean sleep duration (in minutes) assessed via daily sleep diaries

  • HPA-Axis FunctioningFrom enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).

    Salivary cortisol assessed in three ways: hair (chronic stressor exposure), at-home saliva (basal cortisol), and saliva in response to an in-lab stressor (stress reactivity).