Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05949047

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Rice University

Houston, Texas, United States, 77030

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease | DecenTrialz