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Caregiver Stress and Sleep Study for Dementia Caregivers

This study is looking at how stress, sleep, and daily activities affect the mood and brain health of family caregivers for people with dementia. It involves two types of behavioral therapy: one focuses on an "Activity Strategy" with a therapist, and the other is an "Attention-based Session" where a therapist listens to your stressors. Some participants may also be asked to adjust their sleep schedule. The study aims to see if these interventions can improve morning activity levels, reduce depressive symptoms and rumination (repeated negative thoughts), and impact brain connections linked to depression. You might be able to join if you are 55 or older, provide at least 15 hours of unpaid care weekly to someone with dementia, feel stressed by caregiving, and have difficulty with morning activation.

Study design
This is an interventional study planning to enroll 120 participants. It includes a randomized experimental component where participants receive one of two talk-therapy treatments.
What's involved
Participants will meet weekly with a therapist for 30-45 minutes for about 6 weeks. You will also complete surveys, have an MRI scan, and wear an actigraphy watch to track activity and sleep.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after the initial treatment period to assess changes in rumination, depressive symptoms, and anxiety symptoms.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05219955

Caregiver Stress and Sleep Study

Recruiting
NAAges 55+InterventionalBasic science
University of Pittsburgh
~120 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Morning Action Plan ExecutionActivity Strategy-based Session with TherapistAttention-based Session with TherapistAdvance sleep-wake time

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in rumination at 6-months
Measured over Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)
+6 more outcomes measured

Conditions

Depressive Symptoms
Caregiver Burden

Explore related trials

Caregiver BurdenCaregivingDementiaDepression

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Stephen F Smagula, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Sara Sellars, MA
[email protected]
412-246-5963
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change from baseline in rumination at 6-monthsBaseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

    Rumination will be measured using the rumination subscale of the Behavioral Activation Scale for Depression (BASD). There is a minimum possible score of 0 and a maximum possible score of 24 with higher scores indicating higher \[worse\] rumination. This measure will be accessed via Ecological Momentary Assessment (EMA). A link will be sent to participant's mobile device by text message cuing participants to respond

  • Change from baseline in depressive symptoms at 6-monthsBaseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

    Depression will be measured using the Patient Health Questionnaire (PHQ-9). There is a minimum possible score of 0 and a maximum possible score of 27 with higher scores indicating higher \[worse\] depression.

  • Change from baseline in anxiety symptoms at 6-monthsBaseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

    Anxiety will be measured using the Generalized Anxiety Disorder 7-Item Scale (GAD-7). There is a minimum possible score of 0 and a maximum possible score of 21 with higher scores indicating higher \[worse\] anxiety.

  • Change in objective Morning Activation Deficits (MADs) over 1 weekContinuously for up to 1-week at baseline

    Morning activation deficits (MADs), a common component of depression measurable as actigraphy assessed morning inactivity.

  • Change in self-report Morning Activation Deficits (MADs) at 6-monthsBaseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

    Morning Activation Deficits (MADs) will be assessed using the Composite Morningness Questionnaire (CMQ). There is a minimum possible score of 13 and a maximum possible score of 55 with higher scores indicating a higher degree or morningness.

  • Change in resting-state connectivity at 6-weeksBaseline and 6-weeks

    Resting connectivity of the amygdala and ventral posterior cingulate cortex (PCC) structures will be measured by brain imaging conducted with a 7 Tesla scanner

  • Change in neurological response to rumination cues at 6 weeksBaseline and 6-weeks

    Rumination-related brain activation in the Limbic (amygdala), default mode network (DMN), ventral posterior cingulate cortex (PCC), and Frontal Parietal Control Network (FPCN) will be measured by brain imaging conducted with a 7 Tesla scanner.