| NCT ID | NCT05219955 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Depressive Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-07-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-07-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Stephen F Smagula, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05219955 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Depressive Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05219955 currently recruiting?
Yes, NCT05219955 is actively recruiting participants. Contact the research team at alberts3@upmc.edu for enrollment information.
Where is the NCT05219955 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT05219955 clinical trial?
NCT05219955 is sponsored by University of Pittsburgh. The principal investigator is Stephen F Smagula, PhD at University of Pittsburgh. The trial plans to enroll 120 participants.