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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.
Must not have
Significant visual, auditory, or cognitive impairment that compromises their ability to understand and complete the task
Timeline
Screening 1 days
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a smartphone app designed to help unpaid caregivers of Alzheimer's patients manage their emotions better. The app teaches techniques to view stressful situations more objectively and imagine better outcomes, aiming to reduce stress and improve overall well-being.

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.
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.
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 below
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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.
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I provide at least 4 hours of daily care in the recipient's home.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have no major issues with seeing, hearing, or thinking that would stop me from understanding and completing tasks.

Timeline

Screening ~ 1 days
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 1 days for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Caregiver burden
Caregiver quality of life
Depressive symptoms
+8 more
Secondary study objectives
Care recipient affect
Care recipient quality of life
Quick Dementia Rating System (QDRS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cognitive Emotion Regulation Interventions, such as psychological distancing and reinterpretation, work by helping caregivers manage their emotional responses to stress. Psychological distancing involves viewing stressful situations from an objective, detached perspective, which can reduce emotional intensity. Reinterpretation involves reframing a situation to see it in a more positive or less threatening light. These mechanisms are crucial for caregivers as they can alleviate stress, reduce depressive symptoms, and improve overall well-being, enabling them to provide better care for their loved ones while maintaining their own health.

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Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,784 Previous Clinical Trials
28,184,168 Total Patients Enrolled
Bryan DennyLead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
Bryan Denny, Ph.D.Principal InvestigatorWilliam Marsh Rice University
1 Previous Clinical Trials
75 Total Patients Enrolled

Media Library

Cognitive Emotion Regulation Training via Psychological Distancing (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05949047 — N/A
Caregiver Research Study Groups: Reinterpretation, No regulation "Look Only", Distancing
Caregiver Clinical Trial 2023: Cognitive Emotion Regulation Training via Psychological Distancing Highlights & Side Effects. Trial Name: NCT05949047 — N/A
Cognitive Emotion Regulation Training via Psychological Distancing (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05949047 — N/A
~171 spots leftby Nov 2026