Clinical trial for Caregivers
Official title Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
ClinicalTrials.gov ID: NCT05949047
What this study is testing
- What it's testing
- The study aims to see if a one‑week smartphone training in cognitive reappraisal can lower stress, caregiver burden, and depressive symptoms, and improve heart‑rate variability. It also explores how these changes happen over time.
- Who it's for
- Unpaid primary caregivers who look after a family member with Alzheimer's disease or related dementia.
- What's involved
- Participants will be randomly assigned to a smartphone app that teaches either psychological distancing, reinterpretation, or no training. They will use the app for one week, wear a Polar H10 chest band to record heart‑rate variability, and complete brief mood and health questionnaires.
- Time commitment
- The study runs for about three months with assessments at baseline, after the one‑week training, and follow‑up checks at 2 weeks, 4 weeks, and 3 months, all done remotely.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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/
You likely can't join if
- 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...
- Must have a smartphone. This represents any major iOS or Android-based smartphone.
- Must provide significant level of caregiving to their care recipient
- Must be at least minimally-stressed Cognitively Impaired Adults
See the full eligibility 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/
- 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...
- 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...
- 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 study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.