Recruiting

Cognitive Reappraisal

Sponsor:

Bryan Denny

Code:

NCT05949047

Conditions

Caregivers

Emotions

Emotion Regulation

Stress

Psychological

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cognitive Emotion Regulation Training via Psychological Distancing

Cognitive Emotion Regulation Training via Reinterpretation

Study Details

Brief summary:

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

Caregivers

Emotions

Emotion Regulation

Stress

Psychological

Study ID

NCT05949047

Start date

Sep 14, 2023

Status verified date

May, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Healthy Adult Caregivers

  • 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/exclusion criteria are met
  • 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
  • Must be at least minimally-stressed

Cognitively Impaired Adults

  • Must have diagnosed with Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD)
  • Must be the care recipient of the primary caregiver who is completing the study
  • Must be able to understand and willing to complete a questionnaire and the consent form
  • Must have minimum level of dementia symptoms

Exclusion Criteria:

Healthy Adult Caregivers

  • 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/or past substance-related disorders would not represent an exclusion factor)
  • Currently receiving psychotherapy that specifically addresses caregiver burden/distress or employs cognitive reappraisal as a major component
  • Significant visual, auditory, or cognitive impairment that compromises their ability to understand and complete the task
  • Caregiver participants who cease meeting inclusion criteria during the study will be dismissed from the study and compensated pro-rata.
  • Has formerly participated in a study from our lab involving the same or essentially same design (e.g., former participants who provided pilot/preliminary data for this study)

Cognitively Impaired Adults

  • The care recipient does not wish to participate, and/or their caregiver does not want them to participate
  • 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
  • Has formerly participated in a study from our lab involving the same or essentially same design (e.g., former participants who provided pilot/preliminary data for this study)

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Distancing

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).

active comparator: Reinterpretation

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).

no intervention: No regulation "Look Only"

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.

Interventions

Cognitive Emotion Regulation Training via Psychological Distancing

The 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

The 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.

Primary outcome measure

  • Self-reported negative affect [ Time Frame: During Sessions Day 1 - Day 7; this cycle is 7 days ]
  • Ecological momentary assessment of positive and negative affect [ Time Frame: During Sessions Day 1 - Day 7; this cycle is 7 days ]
  • Heart rate variability [ Time Frame: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 ]
  • Perceived stress [ Time Frame: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 ]
  • Caregiver burden [ Time Frame: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 ]
  • Caregiver quality of life [ Time Frame: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 ]
  • Depressive symptoms [ Time Frame: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 ]
  • Difficulty in regulating emotion [ Time Frame: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 ]
  • Positive and negative affect [ Time Frame: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 ]
  • Interpersonal regulation [ Time Frame: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 ]
  • Empathy [ Time Frame: Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3 ]

Central Contacts and Locations

Central contacts

Bryan Denny, Ph.D.

713-348-8257btd3@rice.edu

Locations

Rice University

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Bryan T Denny, PhD

More Information

Sponsor

Bryan Denny

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • emotion regulation
  • caregiving
  • affective science
  • psychophysiology
  • psychoneuroimmunology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bryan Denny on 2026-05-29.