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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
UPMC Western Behavioral Health
Pittsburgh, Pennsylvania, 15213
Sara Sellars, MA, 412-246-5963, alberts3@upmc.edu
Stephen Smagula, PhD
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.
- Conditions
- Depressive Symptoms, Caregiver Burden
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Attention-based Session with Therapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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
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)
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
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)
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)
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)
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)
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
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
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
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.
- First posted2 Feb 2022
- Study start15 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Stephen Smagula, University of Pittsburgh
- Investigators
- Stephen F Smagula, PhD, Principal investigator, University of Pittsburgh
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Stress and Sleep Study
- ClinicalTrials.gov ID
- NCT05219955
- Acronym / sponsor ID
- CARES / STUDY21100123
- Conditions
- Depressive Symptoms, Caregiver Burden
- Keywords
- Depression, Caregiving, Late-Life, Morningness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active condition (SAMM Protocol) | Experimental | Behavioral: Morning Action Plan Execution, Behavioral: Activity Strategy-based Session with Therapist, Behavioral: Advance sleep-wake timeThe 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. |
| Attention-matched supportive control condition | Active comparator | Behavioral: Attention-based Session with TherapistParticipants 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morning Action Plan ExecutionEach day, participants are asked to track if they do the morning activity plan. | Behavioural | Active condition (SAMM Protocol) |
| Activity Strategy-based Session with TherapistParticipants 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. | Behavioural | Active condition (SAMM Protocol) |
| Attention-based Session with TherapistParticipants 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 | Behavioural | Attention-matched supportive control condition |
| Advance sleep-wake timeSome 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.) | Behavioural | Active condition (SAMM Protocol) |
Primary outcome
Change from baseline in rumination at 6-months
Time frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (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
Change from baseline in depressive symptoms at 6-months
Time frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (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.
Change from baseline in anxiety symptoms at 6-months
Time frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (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.
Change in objective Morning Activation Deficits (MADs) over 1 week
Time frame: Continuously for up to 1-week at baseline
Morning activation deficits (MADs), a common component of depression measurable as actigraphy assessed morning inactivity.
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)
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.
Change in resting-state connectivity at 6-weeks
Time frame: Baseline and 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
Change in neurological response to rumination cues at 6 weeks
Time frame: Baseline and 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.
7 secondary outcomes
Change in self-report nocturnal mentation at 6-months
Time frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)
Change in self-report reward anticipation at 6-months
Time frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)
Change in self-report apathy at 6-months
Time frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)
Change in morning light exposure at 6-weeks
Time frame: Baseline and 6-weeks
Change in cognitive functioning at 6-weeks
Time frame: Baseline and 6-weeks
Change in executive function at 6-weeks
Time frame: Baseline and 6-weeks
Change in cognitive functioning at 6-weeks
Time frame: Baseline and 6-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen F Smagula, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
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.