A study on caregiver stress and sleep patterns in dementia caregivers
Official title: Caregiver Stress and Sleep Study
Run by University of Pittsburgh · NCT05219955 · Data updated 2026-11-12
This study is testing a new program to help family caregivers of dementia patients feel better and sleep more soundly by improving their morning energy and reducing feelings of sadness.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | July 15, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | May 19, 2026 |
| Trial ID | NCT05219955 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 60 and older who provide unpaid care to a co-residing dementia patient and report stress or strain in their caregiving role.
✕Probably not a fit
Patients who are currently undergoing active cognitive behavioral therapy or have a probable dementia diagnosis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effects of a behavioral intervention aimed at improving morning activation levels and reducing depressive symptoms among family caregivers of dementia patients. Participants will be randomly assigned to receive either an experimental behavioral probe or a supportive control condition, with the goal of assessing changes in health-relevant measures such as rumination and brain connectivity. The study addresses the significant mental health challenges faced by caregivers, particularly those experiencing morning activation deficits, which have been linked to persistent depression symptoms. By focusing on these vulnerabilities, the research aims to develop targeted interventions for this population.
Why it matters
Potential benefit: If successful, this study could lead to improved mental health and caregiving quality for family caregivers of dementia patients.
How similar studies have gone: Other studies have shown promise in addressing caregiver mental health through targeted interventions, suggesting that this approach may yield beneficial outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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UPMC Western Behavioral Health
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Stephen F Smagula, PhD — University of Pittsburgh
- Study coordinator: Sara Sellars, MA
- Email: alberts3@upmc.edu
- Phone: 412-246-5963
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.