Caregiver Stress and Sleep Study (NCT05219955) | Clinical Trial Compass
RecruitingNot Applicable
Caregiver Stress and Sleep Study
United States120 participantsStarted 2022-07-15
Plain-language summary
The purpose of this research study is to better understand how stress, sleep and activity might impact caregivers' mood and brain health. This study includes a randomized experimental component where therapists will systematically deliver one of two evidence-based talk-therapy treatments. The aim is to evaluate effects on meaningful health-relevant measures including morning activation levels, depression symptoms, rumination, and aspects brain connectivity previously linked with depression. Participants will complete surveys about their caregiving experiences, health, and mood, undergo an MRI, and wear an actigraphy watch that measures activity levels throughout the day and when sleeping.
Who can participate
Age range
55 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:
* Age 55 years or older.
* Provide at least 15 hours/week of unpaid care to a patient with a dementia diagnosis.
* Reporting stress or strain delivering care
* No or stable pharmacotherapy for depression
* Meets screening definition for having morning activation difficulty or a definite morning type per the Composite Morningness Questionnaire (CMQ)
Exclusion Criteria:
* Unsafe or unable to undergo MRI
* Active Cognitive Behavioral Therapy for mood or insomnia
* Probable dementia diagnosis
* Deadly illness or plans to leave the study area
* Current active substance use disorder
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.
What they're measuring
1
Change from baseline in rumination at 6-months
Timeframe: Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)
2
Change from baseline in depressive symptoms at 6-months
Timeframe: Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)
3
Change from baseline in anxiety symptoms at 6-months
Timeframe: Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)
4
Change in objective Morning Activation Deficits (MADs) over 1 week
Timeframe: Continuously for up to 1-week at baseline
5
Change in self-report Morning Activation Deficits (MADs) at 6-months
Timeframe: Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)
6
Change in resting-state connectivity at 6-weeks
Timeframe: Baseline and 6-weeks
7
Change in neurological response to rumination cues at 6 weeks