Testing an Evidence-Based Program for Clinician Burnout

Burnout Clinical Trial

Official title:

Testing an Evidence-Based Program for Physician and Nurse Burnout

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145425
• Other study ID #: "IRB #2022003296"
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: November 2023
• Source: Brown University
• Contact: Lia Antico, PhD
• Phone: 401 328 0763
• Email: lia_antico[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to pilot test an app-based mindfulness training program in reducing burnout in physicians and nurses.

Description:

The main question[s] it aims to answer are:

PRIMARY AIM: Determine if the app-based training reduces the level of cynicism (i.e., one of the two main dimensions of burnout).

SECONDARY AIM: Determine if the app-based training reduces the level of emotional exhaustion (i.e. one of the two main dimensions of burnout), anxiety, worry, depression and intolerance of uncertainty. Determine if the app-based training increases self-compassion, non-reactivity and non-judging about inner experiences.

Participants will be asked to:

• Use an app-based mindfulness training program

• Complete online surveys at baseline, immediately post-intervention and 1 month after the post-intervention as follow up

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Being a physician, resident physician or nurse

• Able to speak English because all study activities will be conducted in English.

• 18+ years

• direct patient care

Exclusion Criteria:

• If using psychotropic medication - not on a stable dosage at least 6 weeks

Related Conditions & MeSH terms

• Burnout
• Burnout, Psychological

Intervention

Other:
• App-Delivered Mindfulness Training (MT)
The program is delivered via a smartphone-based platform, which includes 7 mindfulness-based modules of about 15 minutes of brief didactic and experience-based mindfulness training (audio files).

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	Peter G. Peterson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics.	Age, gender, employment, race, ethnicity	collected at baseline
Primary	Changes in cynicism	The dimension of cynicism in the Maslach Burnout Inventory (MBI) cynicism. The MBI is a validated 22-item self-report measure of risk of burnout. Items are rated on a 7-point Likert scale ranging from 0 (never) to 6 (every day). The investigators will use only one single-item measure of cynicism that was included from the Maslach Burnout Inventory (MBI).	collected at baseline, immediately post-intervention and one month later as follow up
Secondary	The dimension of emotional exhaustion in the Maslach Burnout Inventory (MBI).	The MBI is a validated 22-item self-report measure of risk of burnout. Items are rated on a 7-point Likert scale ranging from 0 (never) to 6 (every day). The investigators will use only one single-item measure of emotional exhaustion that was included from the Maslach Burnout Inventory (MBI).	collected at baseline, immediately post-intervention and one month later as follow up
Secondary	Generalized Anxiety Disorder 7-items (GAD-7).	The GAD-7 is a validated 7-item measure of anxiety rated on a 4-point Likert scale ranging from 0 (Not at all sure) to 3 (Nearly every day).	collected at baseline, immediately post-intervention and one month later as follow up
Secondary	Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale.	The non-reactivity scale is a validated subscale of the 39-item FFMQ which is a self-report psychological measure of mindfulness skills. This subscale contains 7 items which are presented on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never).	collected at baseline, immediately post-intervention and one month later as follow up
Secondary	Five Facet Mindfulness Questionnaire (FFMQ) non-judging scale.	The non-judging scale is a validated subscale of the 39-item FFMQ which is a self-report psychological measure of mindfulness skills. This subscale contains 8 items which are presented on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never).	collected at baseline, immediately post-intervention and one month later as follow up
Secondary	Patient Health Questionnaire 2-item scale (PHQ-2).	The PHQ-2 is a validated 2-item self-report measure of depression. Items are rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).	collected at baseline, immediately post-intervention and one month later as follow up
Secondary	Penn State Worry Questionnaire (PSWQ).	The PSWQ is a validated 16-item self-report measure of worry with items presented on a 5-point Likert scale ranging from 1 (not at all typical of me) to 5 (very typical of me).	collected at baseline, immediately post-intervention and one month later as follow up
Secondary	Intolerance of Uncertainty 12-item scale (IUS-12).	The IUS-12 is a validated 12-item self-report measure of intolerance of uncertainty. Items are rated on a 5-point Likert scale ranging from 1 (not at all characteristic of me) to 5 (entirely characteristic of me).	collected at baseline, immediately post-intervention and one month later as follow up
Secondary	Self-Compassion Scale - Short Form (SCS-SF).	The SCS-SF is a validated 12-item self-report measure of self-compassion. Items are rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always).	collected at baseline, immediately post-intervention and one month later as follow up