Actively Recruiting
Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
Led by Bryan Denny ยท Updated on 2026-04-16
270
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
Sponsors
B
Bryan Denny
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unpaid primary caregiver of patient with Alzheimer's Disease or related dementias (AD/ADRD)
- At least 18 years old, no maximum age limit
- Able to speak, read, and write English
- Free of current or past psychiatric diagnoses except mood, anxiety, or past substance-related disorders
- Must have a smartphone (iOS or Android) for data collection
- Provide significant caregiving to care recipient
- At least minimally stressed
- Care recipients diagnosed with AD/ADRD
- Care recipients able to understand and willing to complete questionnaires and consent
- Care recipients have minimum level of dementia symptoms
You will not qualify if you...
- Current or past psychiatric disorders except mood, anxiety, or past substance-related disorders
- Currently receiving psychotherapy that addresses caregiver burden or uses cognitive reappraisal
- Significant visual, auditory, or cognitive impairment compromising task understanding or completion
- Caregivers who stop meeting inclusion criteria during study
- Previous participation in a study from this lab with similar design
- Care recipients who do not wish to participate or whose caregiver does not want participation
- Care recipients with significant impairments that prevent questionnaire completion even with help
- Care recipients previously involved in similar lab studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rice University
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Bryan Denny, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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