Testing an Evidence-Based Program for Clinician Burnout

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

Detailed Description
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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

Official Title
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Testing an Evidence-Based Program for Physician and Nurse Burnout

Conditions
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Burnout

Intervention / Treatment
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* Other: App-Delivered Mindfulness Training (MT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 3 single groups: physicians, resident physicians and nurses
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>Participants will be asked to utilize the app. | Other: App-Delivered Mindfulness Training (MT)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burnout, Mindfulness, Physicians, Nurses, Resident Physicians