Caregiver Stress and Sleep Study

NCT05219955 | Recruiting DMC

• 2 other identifiers: STUDY21100123MH125846
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study includes a randomized experimental component where therapists will systematically deliver an experimental behavioral probe or a supportive control condition. 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.

Conditions

Depressive Symptoms; Caregiver Burden

Keywords

Depression; Caregiving; Late-Life; Morningness

Outcome Measures

Primary Outcomes (7)

• Change from baseline in rumination at 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

  Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

• Change from baseline in depressive symptoms at 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.

  Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

• Change from baseline in anxiety symptoms at 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.

  Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

• Change in objective Morning Activation Deficits (MADs) over 1 week

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

  Continuously for up to 1-week at baseline

• Change in self-report Morning Activation Deficits (MADs) at 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.

  Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

• Change in resting-state connectivity at 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

  Baseline and 6-weeks

• Change in neurological response to rumination cues at 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.

  Baseline and 6-weeks

Secondary Outcomes (7)

• Change in self-report nocturnal mentation at 6-months

  Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

• Change in self-report reward anticipation at 6-months

  Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

• Change in self-report apathy at 6-months

  Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

• Change in morning light exposure at 6-weeks

  Baseline and 6-weeks

• Change in cognitive functioning at 6-weeks

  Baseline and 6-weeks

Study Arms (2)

Active condition (SAMM Protocol)

EXPERIMENTAL

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.

Behavioral: Morning Action Plan Execution; Behavioral: Activity Strategy-based Session with Therapist; Behavioral: Advance sleep-wake time

Attention-matched supportive control condition

ACTIVE COMPARATOR

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.

Behavioral: Attention-based Session with Therapist

Interventions

Morning Action Plan Execution BEHAVIORAL

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

Active condition (SAMM Protocol)

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.

Active condition (SAMM Protocol)

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

Attention-matched supportive control condition

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.)

Active condition (SAMM Protocol)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 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 types per the Composite Morningness Questionnaire (CMQ)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UPMC Western Behavioral Health

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Depression; Caregiver Burden

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress, Psychological

Study Officials

• Stephen F Smagula, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Sellars, MA

CONTACT

412-246-5963; alberts3@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: July 15, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)