Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT05219955

Conditions

Depressive Symptoms

Caregiver Burden

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

Morning Action Plan Execution

Activity Strategy-based Session with Therapist

Attention-based Session with Therapist

Advance sleep-wake time

Study Details

Brief 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

Study ID

NCT05219955

Start date

Jul 15, 2022

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Morning Action Plan Execution

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

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.

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

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.)

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) ]
  • Change from baseline in depressive symptoms at 6-months [ Time Frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months) ]
  • Change from baseline in anxiety symptoms at 6-months [ Time Frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months) ]
  • Change in objective Morning Activation Deficits (MADs) over 1 week [ Time Frame: Continuously for up to 1-week at baseline ]
  • Change in self-report Morning Activation Deficits (MADs) at 6-months [ Time Frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months) ]
  • Change in resting-state connectivity at 6-weeks [ Time Frame: Baseline and 6-weeks ]
  • Change in neurological response to rumination cues at 6 weeks [ Time Frame: Baseline and 6-weeks ]

Central Contacts and Locations

Central contacts

Sara Sellars, MA

412-246-5963alberts3@upmc.edu

Locations

UPMC Western Behavioral Health

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Sara Sellars, MA

412-246-5963alberts3@upmc.edu

Principal Investigator:

Stephen Smagula, PhD

More Information

Sponsor

University of Pittsburgh

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • Depression
  • Caregiving
  • Late-Life
  • Morningness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-05-19.