NCT05949047 · RECRUITING
Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
This trial tests whether a one-week smartphone-based emotion regulation program can reduce stress, depression, and caregiver burden in unpaid family caregivers of people with Alzheimer's or related dementias. Participants are randomly assigned to one of two mental reframing techniques or a control group, with follow-up over three months. This is a Phase NA behavioral study — it is testing whether the approach works, not evaluating a drug or approved therapy.
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)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-04-16