Recruiting

Caregiver Stress and Sleep Study

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…

ClinicalTrials.gov IDNCT05219955
PhaseNA
Enrollment120
SponsorUniversity of Pittsburgh
Age55 Years
SexALL
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Conditions studied

Depressive Symptoms, Caregiver Burden

About this study

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.

Interventions

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.