A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers

NCT04816708 | Completed Results

• 1 other identifier: Pro00107657
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot randomized waitlist control trial assessing if the feasibility of using a mobile mindfulness app to treat emotional distress and burnout amongst nurses taking care of COVID-19 patients. This trial will help inform the study team if dissemination the intervention to a large number of nurses in a short time period is feasible, and if the intervention has evidence of a clinical impact.

Conditions

Emotional Distress; Burnout, Professional; Stress, Job; Anxiety; Depressive Symptoms

Keywords

Emotional distress; COVID-19; Burnout

Outcome Measures

Primary Outcomes (4)

• Intervention Completion

  The percentage of participants who complete all 4 weeks of the intervention, a measure of feasibility.

  30 days post randomization

• Sessions Completed

  Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility.

  30 days post-randomization

• Survey Completion at Baseline

  The percentage of patients who complete surveys at baseline, a measure of feasibility.

  Baseline

• Survey Completion at 1 Month

  The percentage of patients who complete surveys at 1 month, a measure of feasibility.

  30 days post randomization

Secondary Outcomes (6)

• Change in Patient Health Questionnaire-9 Item Scale (PHQ-9)

  Baseline to 30 days post-randomization

• Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)

  Baseline to 30 days post-randomization

• Change in Perceived Stress Scale (PSS-4)

  Baseline to 30 days post-randomization

• Change in Maslach Burnout Index (MBI) - Emotional Exhaustion

  Baseline to 30 days post-randomization

• Change in Maslach Burnout Index (MBI) - Depersonalization

  Baseline to 30 days post-randomization

Study Arms (2)

Arm 1: Intervention group (access to LIFT mindfulness app)

ACTIVE COMPARATOR

Participants randomized to the intervention arm will be provided access to LIFT app's daily mobile mindfulness therapy for 30 days.

Behavioral: LIFT Mindfulness

Arm 2: Control waitlist group (delayed access to LIFT mindfulness app)

NO INTERVENTION

Control participants will not receive access to the LIFT app daily mobile mindfulness therapy during study period. They may have access to LIFT app daily mobile mindfulness therapy after completion of the study period.

Interventions

LIFT Mindfulness BEHAVIORAL

Mindfulness is a type of mind-body therapy that promotes a practice of non-judgmental awareness that can alleviate distress by uncoupling emotional reactions and habitual behavior from unpleasant symptoms, thoughts, and emotions. LIFT is a mobile mindfulness app which can assess levels of emotional distress via survey, and subsequently offer mindfulness content that has previously been used in ICU patients, where it was shown to reduce symptoms of depression, anxiety, and PTSD.

Arm 1: Intervention group (access to LIFT mindfulness app)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ≥ 18 years of age
• Currently working as a nurse in an adult COVID unit at Duke University Hospital
• English Fluency

You may not qualify if:

• Lack of access to either reliable smartphone with cellular data plan or home internet access.
• Anticipation of leaving current position in ≤30 days.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Pratt EH, Hall L, Jennings C, Olsen MK, Jan A, Parish A, Porter LS, Cox CE. Mobile Mindfulness for Psychological Distress and Burnout among Frontline COVID-19 Nurses: A Pilot Randomized Trial. Ann Am Thorac Soc. 2023 Oct;20(10):1475-1482. doi: 10.1513/AnnalsATS.202301-025OC.

  PMID: 37289650 DERIVED

MeSH Terms

Conditions

Burnout, Professional; Occupational Stress; Anxiety Disorders; Depression; COVID-19; Burnout, Psychological

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Christopher E. Cox, MD
• Organization: Duke University

christopher.cox@duke.edu

919-681-7232

Study Officials

• Christopher Cox, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single site, pilot randomized waitlist control trial

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: May 19, 2021
• Primary Completion: January 30, 2022
• Study Completion: February 4, 2022
• Last Updated: February 22, 2024
• Results First Posted: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)