Smartphone-based Cognitive Emotion Regulation Training for Alzheimer's Caregivers
This study is testing a smartphone-based training program called Cognitive Emotion Regulation Training to help unpaid primary caregivers of people with Alzheimer's disease or related dementias. The training teaches skills like psychological distancing (viewing emotional situations objectively) or reinterpretation (finding a more positive way to think about a situation). Researchers want to see if this training can improve your psychological well-being, such as reducing stress and depressive symptoms. They will also look at how it might affect the quality of life for the person you care for. You can join if you are an unpaid primary caregiver, at least 18 years old, can speak English, and are generally healthy. The study aims to enroll 270 participants.
- Study design
- This study is an interventional study that will randomly assign participants to one of three groups: psychological distancing training, reinterpretation training, or a control group. It plans to enroll 270 participants.
- What's involved
- You will receive a brief course of reappraisal training. Your negative affect and heart rate variability will be measured at various points over approximately three months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your heart rate variability will be measured up to three months after the initial training.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Bryan Denny, Ph.D. · PRINCIPAL_INVESTIGATOR · William Marsh Rice University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Self-reported negative affectDuring Sessions Day 1 - Day 7; this cycle is 7 days
Self-reported negative affect data collected during completion of emotion regulation task via smartphone
- Ecological momentary assessment of positive and negative affectDuring Sessions Day 1 - Day 7; this cycle is 7 days
Ecological momentary assessment (EMA) of positive and negative affect collected during 4 daily afternoon EMA pings via smartphone
- Heart rate variabilityInitial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Heart rate variability measured via smartphone in conjunction with a Bluetooth-connected H10 Polar Chest Band. Change in heart rate variability assessed at the following timepoints:
- Perceived stressInitial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Perceived stress assessed via the Perceived Stress Scale on a scale of 0 to 4, with 0 indicating "Never" and 4 indicating "Very Often". A higher overall score on the stress scale indicates a worse outcome. Change in self-reports of perceived stress assessed at the following timepoints:
- Caregiver burdenInitial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Caregiver burden assessed via the Caregiver Burden Scale on a scale of 0 to 4, with 0 indicating "Never" and 4 indicating "Nearly Always". The greater the total score, the worse the outcome. Change in self-reports of caregiver burden assessed at the following timepoints:
- Caregiver quality of lifeInitial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Caregiver quality of life assessed via the Caregiver Quality of Life Index on a scale of 0 to 4, with 0 indicating "Not at all" and 4 indicating "Very much". A higher overall score on the Caregiver quality of life index indicates a higher quality of life and better outcome. Change in self-reports of caregiver quality of life assessed at the following timepoints:
- Depressive symptomsInitial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Depressive systems assessed via the Center for Epidemiological Studies-Depression (CES-D) Depression Inventory on a scale of 0 to 3, with 0 indicating "Rarely or none of the time (less than 1 day)," and 3 indicating "Most or all of the time (5-7 days)". The higher the score on the CES-D Depression Inventory, the worse the outcome. Change in self-reports of depressive symptoms assessed at the following timepoints:
- Difficulty in regulating emotionInitial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Difficulty in regulating emotion will be assessed using the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF). There are 5 possible responses to a series of questions: almost never (0-10%), sometimes (11-35%), about half of the time (36-65), most of the time (66%-90%), almost always (91-100%). "Almost never" is the minimum score and "almost always) is the maximum score. Higher scores reflect a worse outcome or greater difficulty with emotion regulation. Change in self-reports of regulating emotions assessed at the following timepoints:
- Positive and negative affectInitial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Positive and negative affect assessed via the Positive and Negative Affect Schedule (PANAS) on a scale of 1 to 5, with a score of 1 indicating "Very slightly or not at all" and a score of 5 indicating "extremely". It is scored using two categories, a positive affect score and a negative affect score. Those with a higher positive affect and lower negative affect score have the most positive outcome. Change in self-reports of positive and negative affect assessed at the following timepoints:
- Interpersonal regulationInitial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Interpersonal regulation efficacy assessed via the Interpersonal Regulation Questionnaire on a scale of 1 to 7, with a score of 1 indicating "strongly disagree" and a scale of 7 indicating "strongly agree". A higher score on this questionnaire indicates a change in self-reports of interpersonal regulation assessed at the following timepoints:
- EmpathyInitial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Empathy Assessed via the Interpersonal Reactivity Index (IRI) on a scale of 0 to 4, with a score of 0 indicating "does not describe me well" and a score of 4 indicating "describes very well". A higher score on this index indicates greater levels of empathy. In this study, the degree of empathy the individual scores does not correlate to a better or worse outcome. The Change in self-reports of empathy assessed at the following timepoints: