Caregiver Stress and Sleep Study

Summary

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.

Conditions

• Depressive Symptoms
• Caregiver Burden

Interventions

BEHAVIORAL

Morning Action Plan Execution

Each day, participants are asked to track if they do the morning activity plan.

BEHAVIORAL

Activity Strategy-based Session with Therapist

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.

BEHAVIORAL

Attention-based Session with Therapist

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

BEHAVIORAL

Advance sleep-wake time

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.)

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Stephen F Smagula, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-15

Primary Completion

2026-12-31

Completion

2027-06-30

Countries

• United States

Study Locations