[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456159":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":45,"locations":51,"responsibleParty":70,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":28,"enrollmentInfo":87,"targetDuration":28,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":54,"whyStopped":28,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14,15],"Behavioral: Morning Action Plan Execution","Behavioral: Activity Strategy-based Session with Therapist","Behavioral: Advance sleep-wake time",{"label":17,"type":18,"description":19,"interventionNames":20},"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.",[21],"Behavioral: Attention-based Session with Therapist",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BEHAVIORAL","Morning Action Plan Execution","Each day, participants are asked to track if they do the morning activity plan.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"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.",[9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"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",[17],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"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.)",[9],[42],{"name":43,"affiliation":5,"role":44},"Stephen F Smagula, PhD","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},"Sara Sellars, MA","CONTACT","412-246-5963","alberts3@upmc.edu",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"UPMC Western Behavioral Health","RECRUITING","Pittsburgh","Pennsylvania","15213","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-79.99589,40.44062,{"lat":64,"lon":63},[67,68],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},{"name":69,"role":44,"phone":28,"phoneExt":28,"email":28},"Stephen Smagula, PhD",{"type":44,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Stephen Smagula","Assistant Professor of Psychiatry",[74],{"name":75,"class":76},"National Institute of Mental Health (NIMH)","NIH","100456159","caregiver-stress-and-sleep-study-100456159",false,"NCT05219955","Caregiver Stress and Sleep Study","CARES","Inclusion Criteria:\n\n* Age 55 years or older.\n* Provide at least 15 hours\u002Fweek of unpaid care to a patient with a dementia diagnosis.\n* Reporting stress or strain delivering care\n* No or stable pharmacotherapy for depression\n* Meets screening definition for having morning activation difficulty or a definite morning type per the Composite Morningness Questionnaire (CMQ)\n\nExclusion Criteria:\n\n* Unsafe or unable to undergo MRI\n* Active Cognitive Behavioral Therapy for mood or insomnia\n* Probable dementia diagnosis\n* Deadly illness or plans to leave the study area\n* Current active substance use disorder",true,"ALL","55 Years",{"count":88,"type":89},120,"ESTIMATED","INTERVENTIONAL",[92],"NA","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.",[95,96],"Depressive Symptoms","Caregiver Burden",[98,99,100,101],"Depression","Caregiving","Late-Life","Morningness","2026-05-15",{"date":104,"type":105},"2026-05-19","ACTUAL",{"date":107,"type":105},"2022-07-15",{"date":109,"type":89},"2027-06-30",{"name":5,"class":6},1]