What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Cognitive reappraisal techniques, including psychological distancing and reinterpretation, are generally considered safe with minimal side effects. However, some individuals may experience temporary increases in emotional distress as they confront and reframe challenging thoughts and feelings. Similar psychological treatments, such as cognitive-behavioral therapy (CBT) and mindfulness-based interventions, can also lead to initial discomfort or heightened anxiety as patients work through difficult emotions. Overall, these side effects are typically mild and transient, and the benefits of improved emotional regulation and reduced stress often outweigh these temporary challenges.

What prior FDA approvals exist?

There are no specific FDA-approved treatments exclusively for caregivers that focus on cognitive emotion regulation interventions such as psychological distancing and reinterpretation. However, treatments that address stress, anxiety, and depression, which are common issues among caregivers, include SSRIs and SNRIs like fluoxetine and duloxetine. These medications help manage symptoms of depression and anxiety, which can indirectly benefit caregivers by improving their overall mental health.

What other types of research exist?

Promising novel alternatives to Cognitive Emotion Regulation Intervention for caregivers include: 1) Smartphone-based Cognitive Behavioral Therapy (CBT) which offers flexibility and accessibility, 2) Mindfulness-Based Stress Reduction (MBSR) which has shown efficacy in reducing stress and improving emotional well-being, and 3) Virtual Reality Exposure Therapy (VRET) which provides immersive experiences to manage stress and anxiety. These interventions are supported by recent clinical trials and systematic reviews indicating their potential benefits for caregivers.

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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 day

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.

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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:

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I have no major issues with seeing, hearing, or thinking that would stop me from understanding and completing tasks.

Timeline

Screening ~ 1 day1 visit

Treatment ~ Varies

Follow Up ~ 3 months0 visits

Screening ~ 1 day

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 1 day 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.

0 / 4Eligibility criteria met

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.