Actively Recruiting

Phase Not Applicable
Age: 55Years +
All Genders
Healthy Volunteers
ID05219955

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

Age: 55Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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

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