Mindfulness App for Caregiver Stress

HY
Overseen ByHelen Yates
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mindfulness app designed to reduce stress for caregivers of patients undergoing hematopoietic stem cell transplant, an intense medical procedure. The goal is to determine if the mindfulness-based smartphone application is user-friendly and beneficial for these caregivers, who will engage with the app's six-week program of meditations and exercises. It suits English-speaking caregivers with a smartphone, assisting someone about to undergo this procedure at Moffitt Cancer Center. Participants will provide feedback through surveys and interviews. As an unphased trial, this study allows caregivers to contribute to innovative stress-reduction solutions.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mindfulness app, so it's unlikely that your medications will be affected.

What prior data suggests that this mindfulness app is safe for caregivers?

Studies have shown that mindfulness activities can help reduce stress and emotional distress in caregivers. Research indicates these activities can also improve sleep and reduce anxiety. For example, developers created a mindfulness app to help caregivers of dementia patients feel less burdened and stressed.

Mindfulness apps like the one in this study have been tested with similar caregiver groups and have not caused any serious side effects. This suggests the treatment is generally safe. While researchers are testing this specific app for caregivers of patients undergoing stem cell transplants, the safety record of similar apps is reassuring.12345

Why are researchers excited about this trial?

The Mindfulness-Based Smartphone Application is unique because it offers a convenient, on-the-go solution specifically designed to reduce stress in caregivers of patients undergoing hematopoietic stem cell transplants. Unlike traditional stress reduction methods, which might involve in-person therapy or group sessions, this app provides daily mindfulness modules, including meditations and reflection exercises, directly on a smartphone. Researchers are excited about this treatment because it harnesses technology to make stress management accessible anytime and anywhere, potentially enhancing the well-being of caregivers during a challenging time.

What evidence suggests that this mindfulness app is effective for caregiver stress?

Studies have shown that mindfulness activities can reduce stress and emotional distress in caregivers. A smartphone app offering these activities was tested and showed promise in lowering stress, especially for those caring for people with Alzheimer's. Research also suggests that using such apps can improve sleep and overall emotional well-being. In this trial, participants will access a mindfulness-based smartphone application specifically designed for caregivers of patients undergoing hematopoietic stem cell transplants. This app may help them manage stress during this challenging time.16789

Who Is on the Research Team?

CV

Christine Vinci, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are caring for someone scheduled to receive a hematopoietic stem cell transplant at Moffitt Cancer Center. Participants must be able to give informed consent, read and write in English, own a smartphone, and be willing to download and use the study app.

Inclusion Criteria

I am the caregiver for a patient scheduled for a transplant at Moffitt Cancer Center.
I can understand and agree to the study's procedures and risks.
I can read and write in English.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers use the mindfulness-based smartphone application for six weeks, starting the week prior to the patient's transplant

6 weeks
Baseline and end-of-treatment surveys

Follow-up

Participants are monitored for engagement and usability of the app after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mindfulness-Based Smartphone Application

Trial Overview

The study is testing a mindfulness-based smartphone application designed for caregivers of HCT patients. Thirty caregivers will use the app starting one week before the patient's transplant and continue for six weeks, with surveys and an interview conducted to assess its impact.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: AppExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

American Cancer Society, Inc.

Collaborator

Trials
237
Recruited
110,000+

Citations

Mindfulness-Based App to Reduce Stress in Caregivers of ...

Mindfulness-based interventions (MBIs) show promise for improving stress, emotional distress, and sleep disturbance in caregivers of persons with Alzheimer ...

Mindfulness-Based App to Reduce Stress in Caregivers of ...

Mindfulness-based interventions (MBIs) show promise for improving stress, emotional distress, and sleep disturbance in caregivers of persons with Alzheimer ...

An App-Based Mindfulness-Based Self-compassion Program ...

We developed a mobile smartphone support app designed for primary caregivers of persons with dementia, with the goal of reducing caregiver burden and easing ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37831492/

Mindfulness-Based App to Reduce Stress in Caregivers of ...

Mindfulness-based interventions (MBIs) show promise for improving stress, emotional distress, and sleep disturbance in caregivers of persons with Alzheimer ...

Mindfulness-Based Mobile Apps and Their Impact on Well ...

Efficacy of a smartphone app intervention for reducing caregiver stress: randomized controlled trial. JMIR Ment Health, 7 (7) (2020), p. e17541. 10.2196/17541.

Mindfulness-Based Intervention Using Consumer-Grade ...

The outcome measures assessed include perceived caregiving stress (primary), heart rate variability, depressive symptoms, anxiety symptoms, ...

An App-Based Mindfulness-Based Self-compassion ...

We developed a mobile smartphone support app designed for primary caregivers of persons with dementia, with the goal of reducing caregiver burden and easing ...

Effects of a Social Media–Based Mind-Body Intervention ...

The dependent variables were the total scores of caregivers' health outcomes (stress, caregiver burden, sleep quality, and mindful awareness and ...

Protocol for a randomized controlled trial | PLOS One

This 3-arm randomized controlled trial aims to examine the efficacy of a 6-week mindfulness-based stress management program for allogeneic HCT caregivers.