Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi) (NCT05226585) | Clinical Trial Compass
CompletedNot Applicable
Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi)
United States93 participantsStarted 2021-09-26
Plain-language summary
The purpose of this study is to investigate the mechanisms of change in Cognitive Behavioral Therapy for insomnia (CBTi) in a sample of adults aged 50-65. This study aims to evaluate the pre-post treatment change in sleep, circadian rhythms, biomarkers, cognitive performance, and structural and functional magnetic resonance imaging scans (MRI).
Who can participate
Age range
50 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 50-65
* Normal hearing with or without hearing aids
* Ability to speak and read English and ability to give informed consent
* Possession of a computer with video and audio capabilities
* Meets DSM-5 Criteria for Insomnia Disorder
* Internet speed sufficient for participating in teletherapy (e.g., Zoom Health) or SHUTi (for iCBTi group)
* MoCA scores ≥24 will be deemed normal cognitive status and considered eligible for study participation and/or assessed by the ability to comprehend the baseline screening questionnaires
* Willing to refrain from new external behavioral health or medication treatment for issues pertaining to sleep during participation in the study
* Indication that the individual plans to be in the area for the 6 months following the first baseline assessment
Exclusion Criteria:
* Failure to meet the above "inclusion criteria"
* Current circadian rhythm disorder, sleep deprivation, or hypersomnia and related sleep disorders (assessed with clinical interview and/or self-report) as CBTi has not been validated in these populations. Verified by self-report and/or clinical interview (SCISD-R)
* Untreated sleep disordered breathing (e.g., obstructive sleep apnea) assessed by self-report, clinical interview, and/or diagnostic sleep study (i.e., baseline sleep study PSG)
* Failing to meet criteria for MRI scan (e.g., having metallic implants); see Pre-screen MRI Checklist for full list of exclusions for MRI scans.
* Fear/phobia of needle…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.