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Search / Trial NCT05949047

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

Launched by BRYAN DENNY · Jul 14, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Emotion Regulation Caregiving Affective Science Psychophysiology Psychoneuroimmunology

ClinConnect Summary

This clinical trial is studying a new smartphone-based training program designed to help unpaid caregivers of people with Alzheimer's Disease (AD) manage their emotions and reduce stress. Caregivers often face significant emotional and physical challenges while caring for their loved ones, which can lead to feelings of sadness and overwhelm. The trial aims to teach caregivers skills to improve their emotional well-being through techniques like viewing situations from a different perspective or imagining better outcomes. This training may help caregivers feel less stressed and improve their overall quality of life.

To participate in this study, caregivers must be at least 18 years old, provide at least four hours of care each day to someone with Alzheimer's, and have a smartphone. They should also be experiencing some stress, as indicated by a specific screening tool. Participants will be randomly assigned to different training methods and will complete follow-up assessments over the next few months to see how the training affects their mood and stress levels. This study not only aims to support caregivers but also hopes to benefit the individuals they care for by enhancing the quality of care they receive.

Gender

ALL

Eligibility criteria

  • 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 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)
  • 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)

About Bryan Denny

Bryan Denny is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on ethical practices and regulatory compliance, Bryan Denny collaborates with leading healthcare professionals and institutions to develop and evaluate new therapies. The organization prioritizes patient safety and data integrity, leveraging cutting-edge methodologies and technology to ensure rigorous scientific standards. By fostering partnerships and promoting transparency, Bryan Denny aims to contribute significantly to the advancement of healthcare solutions that address unmet medical needs.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

Bryan Denny, Ph.D.

Principal Investigator

William Marsh Rice University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported