A study on caregiver stress and sleep patterns in dementia caregivers
Caregiver Stress and Sleep Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05219955 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are currently undergoing active cognitive behavioral therapy or have a probable dementia diagnosis may not benefit from this study.
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 performed: Other studies have shown promise in addressing caregiver mental health through targeted interventions, suggesting that this approach may yield beneficial outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 60 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 types 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 this trial is running
Pittsburgh, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.