Caregiver Stress and Sleep Study

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT05219955
Status
Recruiting
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Conditions

  • Caregiver Burden
  • Depressive Symptoms

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Morning Action Plan Execution — BEHAVIORAL
    Each day, participants are asked to track if they do the morning activity plan.
  • Activity Strategy-based Session with Therapist — BEHAVIORAL
    Participants will meet weekly with a trained therapist to discuss their prescribed activity plan. If unsuccessful, at weekly follow-ups, participants are asked to refine their plan or make a new one. Each session lasts about 30-45 minutes.
  • Attention-based Session with Therapist — BEHAVIORAL
    Participants will meet weekly with trained a therapist to talk about stressors they experience, providing an opportunity to voice and self-address their problems. In this control condition, therapists will not deliver any particular strategy except for active listening and referring to the educational materials
  • Advance sleep-wake time — BEHAVIORAL
    Some participants will be asked to adjust their sleep schedule to accommodate morning activity engagement by introducing or altering mechanisms known promote early rising (i.e., light exposure, reward and processes, etc.)

Study Details

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.

Key Dates

Start date
Jul 15, 2022
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Active condition (SAMM Protocol)
    The goal of the SAMM protocol is to increase morning activity engagement over a 6-week period. Participants in this condition will review their morning routine, and make a list of potential morning activities to add. They will choose one activity and develop a plan for doing it. Each day, participants are asked to track if they do the morning activity plan. If unsuccessful, at weekly follow-ups, participants are asked to refine their plan or make a new one.
  • Active Comparator: Attention-matched supportive control condition
    Participants in this condition will receive sessions in the same number and duration as the SAMM experimental condition. Therapists will create a comfortable environment by demonstrating interest, empathy, and acceptance without judgment. Caregivers will be encouraged to talk about stressors they experience, providing an opportunity to voice and self-address their problems. In this control condition, therapists will not deliver any particular strategy except for active listening and referring to the educational materials.

Primary Outcome Measure

Change from baseline in rumination at 6-months [ Time Frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Western Behavioral HealthPittsburghPennsylvania15213
Sara Sellars, MA
[email protected]
412-246-5963
Stephen Smagula, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
UPMC Western Behavioral Health· Pittsburgh, PA

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