Mobile Mindfulness for Psychological Distress in Critical Illness

(Lift 3 Trial)

Not yet recruiting at 2 trial locations
KJ
CC
Overseen ByChristopher Cox
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
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 mobile app called Lift, a mindfulness program designed for survivors of serious heart or lung illnesses. Conditions like heart failure or severe COVID often result in ongoing depression, anxiety, and stress. The study compares Lift to another app-based program, the Enlighten Recovery education program, to determine which better improves mental health and quality of life over six months. Individuals hospitalized for a serious heart or lung issue with lasting anxiety or depression may be suitable for this trial. Participants should understand English or Spanish well enough to use the app and complete study tasks. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance mental health support for individuals facing similar health challenges.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the Lift mobile mindfulness program is safe?

Research has shown that Lift, a mobile mindfulness app, is safe for users. Studies have found that Lift reduces symptoms of depression and anxiety. No reports of harmful side effects exist. Users found the app easy to use and well-liked overall. This suggests that the app is safe and comfortable for those seeking to manage stress and emotional challenges.12345

Why are researchers excited about this trial?

Unlike traditional treatments for psychological distress in critical illness, which often rely on medications or in-person therapy, Lift mobile mindfulness offers a unique, app-based approach. This mobile mindfulness program can provide immediate access to stress reduction techniques anytime and anywhere, making it highly accessible and convenient. Researchers are excited about this treatment because it not only empowers patients to manage their distress independently but also integrates seamlessly into their daily lives, potentially leading to improved mental health outcomes without the need for additional medication.

What evidence suggests that this trial's treatments could be effective for psychological distress in critical illness?

Research has shown that the Lift mobile mindfulness program, which participants in this trial may receive, can improve mental health for those recovering from serious illnesses. One study found that Lift reduced depression symptoms and improved quality of life more effectively than an educational program. Another study found that Lift was better at reducing distress than a phone-based mindfulness program or an educational control. These findings suggest that the Lift app could help manage stress, depression, and anxiety for survivors of serious heart and lung conditions. Meanwhile, the Enlighten Recovery education program, another treatment option in this trial, serves as an active comparator to evaluate its effectiveness against Lift.12346

Who Is on the Research Team?

CC

Christopher Cox, MD, MHA, MPH

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults (18+) who were treated in an ICU for at least 24 hours due to serious heart or lung problems, such as heart failure, sepsis, pneumonia, or severe injury. Participants must have needed breathing support or medications for shock during their hospital stay.

Inclusion Criteria

I am currently using medications to support my heart due to shock.
I am 18 years old or older.
I have been in the ICU for at least 24 hours during the required period.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the Lift mobile mindfulness program or the Enlighten Recovery education program

6 months
Mobile app-based, self-directed

Follow-up

Participants are monitored for changes in depression, anxiety, PTSD symptoms, and quality of life

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Enlighten Recovery education program
  • Lift mobile mindfulness

Trial Overview

The study compares a self-guided mindfulness program called Lift, delivered via mobile app, with an educational recovery program called Enlighten Recovery. The goal is to see which helps improve mental health and quality of life over six months after critical illness.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Lift mobile mindfulnessExperimental Treatment1 Intervention
Group II: Enlighten Recovery education programActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Citations

Mobile Mindfulness Intervention for Psychological Distress ...

This randomized clinical trial evaluates the most effective method for delivering a mindfulness program via mobile app to improve depression ...

Mobile App-Based Mindfulness Intervention for Addressing ...

Mobile app-based mindfulness intervention for addressing psychological distress among survivors of hospitalization for COVID-19 infection.

Self-directed Mobile Mindfulness to Address ICU Survivors ...

Lift reduced depression symptoms and improved quality of life compared to an education ), and approach to in-the-moment symptom management (app vs. therapist).

Self-directed Mobile Mindfulness to Address ICU Survivors ...

The investigators now plan a large, multi-site study to test whether Lift improves mental health and quality of life over six months compared to ...

Optimizing a self-directed mobile mindfulness intervention ...

Through this trial, we will optimize mobile mindfulness by assessing three intervention components and their interactions among 152 cardiorespiratory failure ...

LIFT (Mobile Mindfulness Intervention)

LIFT is a self-guided treatment program that aims to improve quality of life, reduce symptoms, help gain independence quicker, and build stronger ...