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Depressive SymptomsCARESNCT05219955

Caregiver Stress and Sleep Study

A study testing Morning Action Plan Execution, Activity Strategy-based Session with Therapist and Attention-based Session with Therapist in people with Depressive Symptoms and Caregiver Burden, run by University of Pittsburgh at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Depressive Symptoms, Caregiver Burden
What is being tested?
Morning Action Plan Execution, Activity Strategy-based Session with Therapist and Attention-based Session with Therapist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
15 Jul 2022to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sara Sellars, MA contact

412-246-5963

alberts3@upmc.edu

United States1 site, 1 recruiting
  • UPMC Western Behavioral Health

    Pittsburgh, Pennsylvania, 15213

    Sara Sellars, MA, 412-246-5963, alberts3@upmc.edu

    Stephen Smagula, PhD

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Depression symptoms are a major public health concern in family dementia caregivers (dCGs) with shared risk factors. With more people living with dementia in the coming decades, more people will become unpaid dCGs. Replacing dCGs with skilled workers is untenable and would cost an estimated $162 billion annually. An estimated 1 in 5 dCGs have a depressive disorders. Over periods of 1-2 years, studies estimate that 25-48% of dCGs will develop new clinically significant symptoms or disorders. Depression symptoms relate to poorer quality caregiving and have health implications, including increased risk for physical function decline and chronic disease mortality. Especially when other risk factors are present, depression symptoms increase the likelihood that symptoms will worsen and disorders emerge. As in older adults generally, the recent National Academies of Sciences, Engineering, and Medicine report "Families Caring for an Aging America" states that the impact of caregiving on mental health is "highly individual," i.e., allocated to caregivers with vulnerability factors. This study focuses on one such vulnerability, morning activation deficits (MADs), based on evidence that MADs are a promising modifiable target for precision depression interventions in dCGs.

Investigators recently observed that MADs predict the depression symptoms persistence, independent of other key factors in dCGs. Data from dCGs shows that the relationship between MADs and depression symptoms involves heightened resting-state amygdala-posterior cingulate connectivity. In the context of prior literature, this implicates rumination. Given that bi-directional relations are plausible, controlled experimental data are needed to determine if targeting morning inactivation influences depression's mechanisms. If so, this would confirm MADs as a clinically actionable intervention target for controlling associated depression mechanisms.

Investigators piloted targeting MADs by using activity scheduling and monitoring, the logically relevant component of existing approaches, which is called Scheduling Activity and Monitoring Mornings (SAMM). MADs are defined as difficulty "getting going" and related objective morning inactivity. The SAMM protocol aims to increase the ease/level morning activity engagement by making, scheduling, and monitoring a morning action plan. Pilot data demonstrates that SAMM engages the target (MADs) and affects mood. This support the feasibility of using SAMM to probe effects of target modification on the hypothesized (ruminative processes) and alternative pathways. Tracking effects of modifying MADs with multi-modal data will elucidate how MADs may contribute in depression's mechanism. This randomized controlled study is needed to determine if SAMM has causal effects apart from non-specific therapeutic effects. Results will indicate if/how targeting MADs with SAMM could be pursued in precision efficacy trials.

Investigators are not proposing a prevention or treatment efficacy trial. The overarching aim is to delineate a mechanism that investigators propose operates across continuums of depression severity, risk, and resilience. Aim 1 will compare dCGs selected to be on either end of a spectrum: dCGs with MADs at levels linked with depression symptoms versus "morning type" dCGs who habitually prefer morning activity engagement. This provides a window into the mechanism by which MADs predict depression symptom persistence, while being a "morning type" appears protective. This contrasts with the designs of depression risk/incidence, prevention efficacy, and treatment efficacy studies; such studies select participants based on depression thresholds, which here, would restrict natural variability in (and bias estimates of) the mechanism of interest. This contrasts with case-controlled studies that compare people with/without depression (regardless of morning activation); such designs could add mechanistic heterogeneity and divert signal from the process by which MADs relate to depression symptoms.

Aim 1 (observing mechanistic differences comparing ends of the MAD exposure spectrum): To characterize differences between dCGs who have MADs, compared with "morning type" dCGs, with regard to: (A) daily patterns rumination and mood symptoms; (B) resting-state connectivity; and (C) rumination cue-related activation.

Hypotheses: The group with MADs will have relatively (A) greater rumination and depression symptoms; and (B) greater resting amygdala-PCC connectivity; and (C) exaggerated limbic, DMN, and FPCN responses to rumination cues.

Additional model testing: Unique from concurrent correlations, MADs will predict later rumination and depression symptoms.

Aim 2 (modifying target): Among dCGs with MADs, test the effects of an active experimental probe targeting morning activity engagement (SAMM), compared with a contact-time matched control condition, on self-reported and actigraphy measured MADs.

Hypotheses: Relative to the control condition, the active probe will be associated with decreased self-reported MADs and increased actigraphy-measured morning activity.

Aim 3 (modifying mechanism via target): (A) Test effects of the active vs. control probes on EMA-measured rumination, resting-state connectivity, and brain network responses to rumination cues. (B) Evaluate if the probe's effects are explained by increases in morning activation.

Hypotheses: SAMM (vs. control) will be associated with reduced rumination and changes in the biomarker pattern listed in Aim 1.

Additional model testing: Experimental effects will be mediated by morning activation increases.

Being tested
Morning Action Plan Execution, Activity Strategy-based Session with Therapist, Attention-based Session with Therapist, Advance sleep-wake time
Keywords
Depression, Caregiving, Late-Life, Morningness
Medical subject headings
Depression, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Morning Action Plan ExecutionBehavioural

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

  • Activity Strategy-based Session with TherapistBehavioural

    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 TherapistBehavioural

    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 timeBehavioural

    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 groups in NCT05219955
Study groupRoleWhat they receive
Active condition (SAMM Protocol)ExperimentalThe 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.
Receives: Behavioral: Morning Action Plan Execution; Behavioral: Activity Strategy-based Session with Therapist; Behavioral: Advance sleep-wake time
Attention-matched supportive control conditionActive comparatorParticipants 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.
Receives: Behavioral: Attention-based Session with Therapist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

    Measured: Continuously for up to 1-week at baseline

  5. 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.

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

  6. 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

    Measured: Baseline and 6-weeks

  7. 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.

    Measured: Baseline and 6-weeks

Secondary outcomes (7)
  1. Change in self-report nocturnal mentation at 6-months

    Nocturnal mentation will be assessed using the nocturnal mentation subscale of Dream Recall Frequency Scale. There is a minimum possible score of 0 and a maximum possible score of 24 with higher scores [better] indicating less negative thoughts/feelings.

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

  2. Change in self-report reward anticipation at 6-months

    Reward anticipation will be assessed using the a custom measure (e.g., "How much do you anticipate that your upcoming activities/things you do will be rewarding?"). There is a minimum possible score of 0 and a maximum possible score of 27 with higher scores indicating a higher degree of reward anticipation.

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

  3. Change in self-report apathy at 6-months

    Apathy will be assessed using the Apathy Evaluation Scale. There is a minimum possible score of 18 and a maximum possible score of 72 with higher scores indicating a less apathy [better].

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

  4. Change in morning light exposure at 6-weeks

    Light exposure will be assessed as lux levels in the morning from sensors on the actigraph

    Measured: Baseline and 6-weeks

  5. Change in cognitive functioning at 6-weeks

    Cognitive functioning will be measured by the Montreal Cognitive Assessment (MoCA), which was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visual constructional skills, conceptual thinking, calculations, and orientation. There is a minimum possible score of 0 and maximum possible score of 30 with a higher score indicating better cognitive function. A score of 26 or above is considered normal.

    Measured: Baseline and 6-weeks

  6. Change in executive function at 6-weeks

    Executive function will be assessed by the Stroop Neuropsychological Screening Test, which was designed to measure inhibition. Participants have 120 seconds to name as many of the stimuli items as possible. Those with the ability to accurately employ inhibitory control, have better executive function. Scoring is based on percentiles and normative values, thus there is no minimum or maximum possible scores to report.

    Measured: Baseline and 6-weeks

  7. Change in cognitive functioning at 6-weeks

    Cognitive function will be assessed by the Trail-Making Test A and B, which was designed to measure executive function and memory. The Trail Making Test is scored by how long it takes to complete the test. The average time it takes to complete Part A is 29 seconds and a time greater than 78 seconds indicates impairment in these cognitive domains. The average time it takes to complete Part B is 75 seconds and a time greater than 273 seconds indicates impairment in these cognitive domains.

    Measured: Baseline and 6-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start15 Jul 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05219955
Sponsor's protocol ID
STUDY21100123
Other IDs
MH125846
Acronym
CARES
Status last verified
May 2026
First submitted
21 Jan 2022
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Morning Action Plan Execution, Activity Strategy-based Session with Therapist and Attention-based Session with Therapist in people with Depressive Symptoms and Caregiver Burden, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sara Sellars, MA (412-246-5963, alberts3@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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