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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Power analysis for caregiver perceived stress, caregiver burden, depressive symptoms: Sufficient power to assess questionnaire outcomes (e.g., perceived stress, caregiver burden, depressive symptoms) will be achieved by recruiting 90 participants per training condition."
  • "Loss to follow-up will be mitigated via systematic tracking of participant progress during the experiment (e.g., timeliness and completeness of training via Qualtrics from T1-T7; completion rate for daily EMA pings; and timeliness and completeness of questionnaires)."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a one-week smartphone training to help unpaid main caregivers of people with Alzheimer's disease or related dementia manage emotions. It looks at whether training lowers stress, caregiving strain, and signs of depression, and whether it helps the person receiving care have a better quality of life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Caregivers: Be age 18 or older and provide a large amount of unpaid care as the main caregiver.
  • Caregivers: Care for someone with Alzheimer's disease or related dementia.
  • Caregivers: Be able to speak, read, and write in English.
  • Caregivers: Have an iPhone or Android smartphone.
  • Caregivers: Feel at least a little stressed.
  • Caregivers: Have no current or past mental health diagnosis, except mood or anxiety disorders or past substance use disorders.
  • People receiving care: Have Alzheimer's disease or related dementia, with at least a minimum level of symptoms, and receive care from a caregiver in the study.
  • People receiving care: Be able to understand and willing to complete a questionnaire and consent form.

Who can't join

  • Caregivers: Have a current or past mental health disorder other than the allowed exceptions listed above.
  • Caregivers: Currently get talk therapy that focuses on caregiving stress or uses changing how you think about events as a main method.
  • Caregivers: Have trouble seeing, hearing, or thinking that prevents them from understanding or doing study tasks.
  • Caregivers: Stop meeting the study rules during the study. They will leave the study and be paid for the part they completed.
  • People receiving care: Do not want to join, or their caregiver does not want them to join.
  • People receiving care: Cannot understand or complete questionnaires because of trouble seeing, hearing, or thinking, even with help from their caregiver.
  • Either group: Have already joined a study from this lab with the same or nearly the same design.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 sites (1)

TX