[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychophysiology\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychophysiology":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100512176","smartphone-based-cognitive-emotion-regulation-training-for-unpaid-primary-caregivers-of-persons-with-alzheimers-disease-100512176",false,"NCT05949047","Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease","Biobehavioral Mechanisms of Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease","Inclusion Criteria:\n\nHealthy Adult Caregivers\n\n* Unpaid primary caregiver of patient with Alzheimer's Disease\u002FAlzheimer's Disease and Related Dementias (AD\u002FADRD)\n* At least 18 years of age, with no maximum age, provided that all other inclusion\u002Fexclusion criteria are met\n* Must be able to speak, read, and write in English\n* Must be free of any current or past DSM diagnosis (i.e. healthy adults), with the exception of current or past mood or anxiety disorders or past substance-related disorders (i.e., current or past mood or anxiety disorders and\u002For past substance-related disorders would not represent an exclusion factor)\n* Must have a smartphone. This represents any major iOS or Android-based smartphone. The smartphone will also be used for collection of ecological momentary assessment (EMA) data via SurveySignal.\n* Must provide significant level of caregiving to their care recipient\n* Must be at least minimally-stressed\n\nCognitively Impaired Adults\n\n* Must have diagnosed with Alzheimer's Disease\u002FAlzheimer's Disease and Related Dementias (AD\u002FADRD)\n* Must be the care recipient of the primary caregiver who is completing the study\n* Must be able to understand and willing to complete a questionnaire and the consent form\n* Must have minimum level of dementia symptoms\n\nExclusion Criteria:\n\nHealthy Adult Caregivers\n\n* Current or past psychiatric disorders (e.g., psychotic and personality disorders) with the exception of current or past mood or anxiety disorders or past substance-related disorders (i.e., current or past mood or anxiety disorders and\u002For past substance-related disorders would not represent an exclusion factor)\n* Currently receiving psychotherapy that specifically addresses caregiver burden\u002Fdistress or employs cognitive reappraisal as a major component\n* Significant visual, auditory, or cognitive impairment that compromises their ability to understand and complete the task\n* Caregiver participants who cease meeting inclusion criteria during the study will be dismissed from the study and compensated pro-rata.\n* Has formerly participated in a study from our lab involving the same or essentially same design (e.g., former participants who provided pilot\u002Fpreliminary data for this study)\n\nCognitively Impaired Adults\n\n* The care recipient does not wish to participate, and\u002For their caregiver does not want them to participate\n* Significant visual, auditory, or cognitive impairment that compromises their ability to understand and complete questionnaires, even with their caregiver's help will exclude them from the study\n* Has formerly participated in a study from our lab involving the same or essentially same design (e.g., former participants who provided pilot\u002Fpreliminary data for this study)",true,"ALL","18 Years",{"count":20,"type":21},270,"ESTIMATED","INTERVENTIONAL",[24],"NA","Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) not only exact a heavy toll on patients, they also impose an enormous emotional, physical, and financial burden on unpaid, often family, caregivers. The strain of providing care for a loved one diagnosed with AD, often across several years, is associated with elevated depression risk and poorer overall health. Emotion regulation skills represent an ideal target for psychological intervention to promote healthy coping in ADRD caregivers. The project seeks to use an experimental medicine approach to test the efficacy and biobehavioral mechanisms of a novel, relatively brief, targeted, scalable, smartphone-based cognitive emotion regulation intervention aimed at improving psychological outcomes (i.e., reducing perceived stress, caregiver burden, and depressive symptoms) in ADRD unpaid primary caregivers as well as examine potential benefits of the caregiver intervention on quality of life in care recipients. Cognitive reappraisal is the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal can be operationalized via two primary tactics: psychological distancing (i.e. appraising an emotional stimulus as an objective, impartial observer) and reinterpretation (i.e., imagining a better outcome than what initially seemed apparent). The project will investigate the efficacy and underlying biobehavioral mechanisms of a novel, one-week cognitive reappraisal intervention in this population, with follow-up assessments at 2 weeks, 4 weeks, and 3 months. ADRD unpaid primary caregivers will be randomly assigned to receive training in either distancing, reinterpretation, or a no regulation natural history control condition, with ecological momentary assessments of self-reported positive and negative affect, remotely- collected psychophysiological health-related biomarkers (i.e., heart rate variability data) using pre-mailed Polar H10 chest bands, and health-related questionnaire reports. Distancing training is expected to result in longitudinal reductions in self-reported negative affect, longitudinal increases in positive affect, and longitudinal increases in HRV that are larger than those attributable to reinterpretation training and no-regulation control training.",[27,28,29,30,31,32],"Caregivers","Emotions","Emotion Regulation","Stress","Psychological","Psychophysiology",[34,35,36,37,38],"emotion regulation","caregiving","affective science","psychophysiology","psychoneuroimmunology","RECRUITING","2026-05-27",{"date":42,"type":43},"2026-05-29","ACTUAL",{"date":45,"type":43},"2023-09-14",{"date":47,"type":21},"2027-05-31",{"name":49,"class":50},"Bryan Denny","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":16,"sex":59,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":73,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":51},"100578015","stress-reactivity-and-mother-infant-cardiovascular-disease-risk-100578015","NCT06805799","Stress Reactivity and Mother-Infant Cardiovascular Disease Risk","Maternal-Infant Stress Reactivity as an Intergenerational Pathway to Cardiovascular Disease Risk","Inclusion Criteria:\n\n* For the parent RCT study: Inclusion criteria: singleton pregnancy, English speaking, \\>18 years old, \\\u003C20 weeks' gestation at enrollment, normotensive at enrollment, and criteria consistent with 'moderate' to 'high' risk for preeclampsia based on American College of Obstetrician and Gynecologist guidelines. For the current research study: Participants will be (n=40) individuals from the parent RCT who have consented to be contacted for future research in the parent study and are not pregnant during the mentored research study procedures.\n\nExclusion Criteria:\n\nFor the parent RCT study: Exclusion criteria: multiple gestations; chronic hypertension; active suicidality or psychosis; ongoing mind-body practice (e.g., yoga, meditation, mindfulness \\> once a week).\n\n\\-","FEMALE","6 Months",{"count":62,"type":21},40,[24],"Prenatal Mindfulness training (MT) shows promise as a preventive intervention against hypertensive disorders of pregnancy (HDP) and may reduce risk for offspring cardiovascular disease (CVD). One proposed mechanism of MT to reduced CVD risk is improved self-regulation following stress. Perhaps the most crucial contributor to the development of self-regulation in the first year is the psychophysiological coregulatory relationship between mother and infant. However, this self-and co-regulation among women exposed to prenatal MT has not been studied and has yet to be examined in relation to CVD risk. The goal of this proposed project is to evaluate maternal-infant physiological reactivity to and recovery from stress at 6 months postpartum following prenatal MT, and to examine the relationship between these maternal infant stress responses and maternal-infant CVD risk at 12 months postpartum.\n\nUsing a lab-based stress paradigm and well-validated biomarkers of mother and infant CVD risk, the investigators will assess respiratory sinus arrhythmia and heart rate at 6 months postpartum for 40 mother-infant dyads who have completed either prenatal MT or a usual care arm of an RCT examining MT for women at risk for HDP. The investigators will compare maternal, infant, and dyadic stress responses by treatment arm. Then, cardiac stress responses will be examined as predictors of maternal and infant biomarkers of CVD risk at 12 months postpartum.",[66,67,68,69,70,32,71,72],"Maternal Health","Infant Health","Hypertension","Behavioral Medicine","Mindfulness","Cardiovascular Diseases","Cardiovascular Diseases Risk",[70,32,74,75,76,68],"Coregulation","Maternal-infant Coregulation","Cardiovascular Disease Risk","NOT_YET_RECRUITING","2026-03-31",{"date":80,"type":43},"2026-04-01",{"date":82,"type":21},"2026-04-15",{"date":84,"type":21},"2026-07-31",{"name":86,"class":50},"Lifespan"]