RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-14
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05949047

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Unpaid primary caregiver of patient with Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD)
  2. * At least 18 years of age, with no maximum age, provided that all other inclusion/exclusion criteria are met
  3. * Must be able to speak, read, and write in English
  4. * 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)
  5. * 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.
  6. * Must provide at least 4 hours of active caregiving a day to their care recipient in the care recipient's home
  7. * Must be at least minimally-stressed (i.e., CES-D score of at least 16)
  8. * Must have diagnosed with Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD)
  9. * Must be the care recipient of the primary caregiver who is completing the study
  10. * Must be able to understand and willing to complete a questionnaire and the consent form
  11. * Must have a Quick Dementia Rating System (QDRS) rating of at least 6
  1. * Current or past DSM diagnosis, 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)
  2. * Currently receiving psychotherapy that specifically addresses caregiver burden/distress or employs cognitive reappraisal as a major component
  3. * Significant visual, auditory, or cognitive impairment that compromises their ability to understand and complete the task
  4. * Caregiver participants who cease meeting inclusion criteria during the study (e.g., if the care recipient enters a skilled nursing facility during the study and inclusion criteria above are no longer met) will be dismissed from the study and compensated pro-rata.
  5. * 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)
  6. * The care recipient does not wish to participate, and/or their caregiver does not want them to participate
  7. * 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
  8. * 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)

Contacts and Locations

Study Contact

Bryan Denny, Ph.D.
CONTACT
713-348-8257
btd3@rice.edu

Principal Investigator

Bryan Denny, Ph.D.
PRINCIPAL_INVESTIGATOR
William Marsh Rice University

Study Locations (Sites)

Rice University
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Bryan Denny

  • Bryan Denny, Ph.D., PRINCIPAL_INVESTIGATOR, William Marsh Rice University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-14
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2023-09-14
Study Completion Date2027-05-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Caregivers
  • Emotions
  • Emotion Regulation
  • Stress
  • Psychological
  • Psychophysiology