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Behavioural Intervention
Smartphone-Based Cognitive Emotion Regulation Training for Caregiver Stress
N/A
Recruiting
Led By Bryan Denny, Ph.D.
Research Sponsored by Bryan Denny
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unpaid primary caregiver of patient with Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD)
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.
Timeline
Screening 1 days
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial seeks to use an experimental medicine approach to test a smartphone-based intervention to help caregivers of people with Alzheimer's Disease and Alzheimer's Disease-Related Dementias cope with the emotional, physical and financial burden of caregiving.
Who is the study for?
This trial is for unpaid primary caregivers of Alzheimer's patients who are over 18, speak English, provide at least 4 hours of care daily, and experience some stress. They must be generally healthy with no major psychological diagnoses except certain mood or anxiety disorders. Participants need a smartphone to receive training and complete assessments.Check my eligibility
What is being tested?
The study tests two types of cognitive emotion regulation training delivered via smartphone: one focuses on reinterpreting situations positively (Reinterpretation), the other on viewing them from an emotionally detached perspective (Psychological Distancing). Caregivers will be randomly assigned to one of these trainings or a control group without regulation guidance.See study design
What are the potential side effects?
Since this intervention involves psychological techniques rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort when engaging in new strategies for managing their emotions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am the main caregiver for someone with Alzheimer's and I do not get paid.
Select...
I own a smartphone capable of running iOS or Android apps.
Select...
I provide at least 4 hours of daily care in the recipient's home.
Timeline
Screening ~ 1 days1 visit
Treatment ~ Varies
Follow Up ~ 3 months0 visits
Screening ~ 1 days
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Caregiver burden
Caregiver quality of life
Depressive symptoms
+8 moreSecondary outcome measures
Care recipient affect
Care recipient quality of life
Quick Dementia Rating System (QDRS)
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: DistancingExperimental Treatment1 Intervention
Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction via videoconference in which detailed instructions for implementation of the distancing strategy is explained (i.e. appraising an emotional stimulus as an objective, impartial observer).
Group II: ReinterpretationActive Control1 Intervention
Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction via videoconference in which detailed instructions for implementation of the reinterpretation strategy is explained (i.e. imagining a better outcome than what initially seemed apparent).
Group III: No regulation "Look Only"Active Control1 Intervention
The No Regulation "Look Only" Control group will serve as a habituation and natural history control; they will see the same emotional images, but they will only be cued to look and respond naturally for all trials.
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,615 Total Patients Enrolled
Bryan DennyLead Sponsor
1 Previous Clinical Trials
84 Total Patients Enrolled
Bryan Denny, Ph.D.Principal InvestigatorWilliam Marsh Rice University
1 Previous Clinical Trials
84 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently in therapy for caregiver stress or learning to change my thoughts.I am the main caregiver for someone with Alzheimer's and I do not get paid.I provide at least 4 hours of daily care in the recipient's home.I have no major issues with seeing, hearing, or thinking that would stop me from understanding and completing tasks.I own a smartphone capable of running iOS or Android apps.I am a healthy adult caregiver.I am 18 years old or older.I am a healthy adult caregiver.
Research Study Groups:
This trial has the following groups:- Group 1: Reinterpretation
- Group 2: No regulation "Look Only"
- Group 3: Distancing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Days to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 7 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research team continue to accept participants in this experiment?
"Clinicialtrials.gov indicates that the recruitment period for this trial, which began on August 15th 2023 and concluded July 14th 2023 has ended. However, there are currently 770 clinical trials accepting participants at present."
Answered by AI
What benefits are researchers hoping to uncover with this trial?
"This trial's primary outcome, monitored from Sessions Day 1 - 7, is an Ecological momentary assessment of positive and negative affect. Secondary outcomes include the Quick Dementia Rating System (QDRS), Revised Memory and Behavior Problem Checklist (RMBPC) scores with Frequency Score ranging 0 to 4, Reaction Scoring also between 0-4; Care recipient Affect evaluated by Self-Assessment Manikin ratings for Valence and Arousal at certain intervals."
Answered by AI
Who else is applying?
What site did they apply to?
Rice University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
How responsive is this trial?
Most responsive sites:
- Rice University: < 48 hours
Typically responds via
Phone Call
Average response time
- < 2 Days
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