About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Unpaid primary caregiver of patient with Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD)
At least 18 years of age, with no maximum age, provided that all other inclusion/
Disqualifiers
Must be able to speak, read, and write in English
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/or past substance-related disorders would not represent an exclusion factor)
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.
Must provide significant level of caregiving to their care recipient
Trial design
Parallel
Treatments tested in this trial
Cognitive Emotion Regulation Training via Psychological Distancing
BehavioralThe project will randomly assign Alzheimer's Disease or related dementia (AD/ADRD) 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.
Cognitive Emotion Regulation Training via Reinterpretation
BehavioralThe project will randomly assign Alzheimer's Disease or related dementia (AD/ADRD) 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.
Treatment groups
Trial outcomes
Primary outcomes
Self-reported negative affect
Self-reported negative affect data collected during completion of emotion regulation task via smartphone
Ecological momentary assessment of positive and negative affect
Ecological momentary assessment (EMA) of positive and negative affect collected during 4 daily afternoon EMA pings via smartphone
Heart rate variability
Heart rate variability measured via smartphone in conjunction with a Bluetooth-connected H10 Polar Chest Band. Change in heart rate variability assessed at the following timepoints:
Perceived stress
Perceived stress assessed via the Perceived Stress Scale on a scale of 0 to 4, with 0 indicating "Never" and 4 indicating "Very Often". A higher overall score on the stress scale indicates a worse outcome. Change in self-reports of perceived stress assessed at the following timepoints:
Secondary outcomes
Reappraisal usage frequency
General/overall reappraisal usage frequency assessed via the Emotion Regulation Questionnaire
Reappraisal usage frequency
General/overall reappraisal usage frequency assessed via the Emotion Regulation Questionnaire
Reappraisal usage frequency
General/overall reappraisal usage frequency assessed via the Emotion Regulation Questionnaire
Reappraisal usage frequency
General/overall reappraisal usage frequency assessed via the Emotion Regulation Questionnaire
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bryan Denny
Lead sponsor
William Marsh Rice University
Sponsor institution
National Institute on Aging (NIA)
Collaborator