Actively Recruiting
Caregiver Stress and Sleep Study Evaluating Morning Activity and Mood in Dementia Caregivers
Led by University of Pittsburgh · Updated on 2026-05-19
120
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how stress, sleep, and daily activity affect mood and brain health in unpaid family caregivers of people with dementia. The study focuses on depression symptoms, morning activation deficits (difficulty getting going in the morning), and brain connectivity patterns linked to depression. It includes a randomized component comparing two talk-therapy treatments to explore how changes in morning activity might influence depression-related brain mechanisms. Participants will be randomly assigned to one of two groups. One group follows the Scheduling Activity and Monitoring Mornings (SAMM) protocol, which involves creating and tracking a morning activity plan over six weeks with weekly therapist sessions to adjust plans as needed. The other group receives supportive therapy sessions focused on active listening without specific activity strategies. Some participants may also adjust their sleep schedules to support earlier morning activity. During the study, participants complete surveys on mood and caregiving experiences, wear an activity-tracking watch, and undergo brain MRI scans at baseline and follow-up. Researchers will measure changes in rumination, depressive and anxiety symptoms, morning activation deficits, brain connectivity, and responses to rumination cues. Follow-up assessments occur up to six months after starting the intervention to monitor lasting effects and mechanisms involved in depression symptoms among caregivers.
CONDITIONS
Brief Title
Caregiver Stress and Sleep Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 55 years or older
- Provide at least 15 hours per week of unpaid care to a person with dementia
- Currently experiencing stress or strain related to caregiving
- No depression medication or stable pharmacotherapy for depression
- Meet screening criteria for morning activation difficulty or definite morning type per the Composite Morningness Questionnaire
You will not qualify if you...
- Unsafe or unable to undergo MRI
- Currently receiving active Cognitive Behavioral Therapy for mood or insomnia
- Probable diagnosis of dementia
- Life-threatening illness or plans to leave the study area
- Current active substance use disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants engage in weekly sessions with a therapist for up to 6 weeks. Those in the active condition develop and track a morning activity plan daily, with weekly follow-ups to adjust the plan as needed. Participants in the control condition receive supportive therapy sessions of similar frequency and duration without specific behavioral strategies.
Weekly visits for 6 weeks
Duration - 6 months
Participants are monitored for changes in mood, rumination, anxiety, and morning activity deficits up to 6 months after treatment completion.
1 visit (in-person) at 6 months
Trial Site Locations
Total: 1 location
1
UPMC Western Behavioral Health
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
S
Sara Sellars, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here