[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512176":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":39,"locations":44,"responsibleParty":67,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":24,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":24,"enrollmentInfo":85,"targetDuration":24,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":99,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"William Marsh Rice University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Distancing","EXPERIMENTAL","Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction via videoconference in which detailed instructions for implementation of the distancing strategy is explained (i.e. appraising an emotional stimulus as an objective, impartial observer).",[13],"Behavioral: Cognitive Emotion Regulation Training via Psychological Distancing",{"label":15,"type":16,"description":17,"interventionNames":18},"Reinterpretation","ACTIVE_COMPARATOR","Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction via videoconference in which detailed instructions for implementation of the reinterpretation strategy is explained (i.e. imagining a better outcome than what initially seemed apparent).",[19],"Behavioral: Cognitive Emotion Regulation Training via Reinterpretation",{"label":21,"type":22,"description":23,"interventionNames":24},"No regulation \"Look Only\"","NO_INTERVENTION","The No Regulation \"Look Only\" Control group will serve as a habituation and natural history control; they will see the same emotional images, but they will only be cued to look and respond naturally for all trials.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"BEHAVIORAL","Cognitive Emotion Regulation Training via Psychological Distancing","The project will randomly assign Alzheimer's Disease or related dementia (AD\u002FADRD) unpaid primary caregivers to receive a brief course of reappraisal training using either psychological distancing or reinterpretation, or to a no regulation natural history control condition. In the Psychological Distancing group, participants will be asked to down-regulate negative emotion by reappraising an emotional stimulus as an objective, impartial observer.",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"Cognitive Emotion Regulation Training via Reinterpretation","The project will randomly assign Alzheimer's Disease or related dementia (AD\u002FADRD) unpaid primary caregivers to receive a brief course of reappraisal training using either psychological distancing or reinterpretation, or to a no regulation natural history control condition. In the Reinterpretation group, participants will be asked to down-regulate negative emotion by imagining a better outcome (when engaging with an emotional stimulus) than what initially seemed apparent.",[15],[36],{"name":37,"affiliation":5,"role":38},"Bryan Denny, Ph.D.","PRINCIPAL_INVESTIGATOR",[40],{"name":37,"role":41,"phone":42,"phoneExt":24,"email":43},"CONTACT","713-348-8257","btd3@rice.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Rice University","RECRUITING","Houston","Texas","77030","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-95.36327,29.76328,{"lat":57,"lon":56},[60,64,66],{"name":61,"role":41,"phone":62,"phoneExt":24,"email":63},"Lexi O'Brien, BA","713-348-8246","lo25@rice.edu",{"name":65,"role":41,"phone":42,"phoneExt":24,"email":43},"Bryan T Denny, PhD",{"name":65,"role":38,"phone":24,"phoneExt":24,"email":24},{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Bryan Denny","Assistant Professor",[72],{"name":73,"class":74},"National Institute on Aging (NIA)","NIH","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":86,"type":87},270,"ESTIMATED","INTERVENTIONAL",[90],"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.",[93,94,95,96,97,98],"Caregivers","Emotions","Emotion Regulation","Stress","Psychological","Psychophysiology",[100,101,102,103,104],"emotion regulation","caregiving","affective science","psychophysiology","psychoneuroimmunology","2026-05-27",{"date":107,"type":108},"2026-05-29","ACTUAL",{"date":110,"type":108},"2023-09-14",{"date":112,"type":87},"2027-05-31",{"name":69,"class":6},1]