Back to resultsMindfulness in Medical Training (MiMT)
Primary Purpose
Mindfulness, Burnout, Anxiety, Sleep
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Headspace
Sponsored by
About this trial
This is an interventional treatment trial for Mindfulness, Burnout, Anxiety, Sleep
Eligibility Criteria
Inclusion Criteria: University of Arizona resident or fellow Exclusion Criteria: none
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Did Not Use Headspace
Did Use Headspace
Arm Description
Those that did not use headspace during the time the study is conducted
Those that were randomized into the group and used Headspace at least once during the study period
Outcomes
Primary Outcome Measures
The Effects on Burnout
The intervention group will be asked to fill out the Maslachs Burnout Inventory (MBI) survey prior to intervention starting, 30 days after start of intervention and then again at 90 days after start of intervention). the MBI is a measure of three independent constructs - emotional exhaustion, depersonalization, and personal accomplishment. Lower scores will indicate less of an impact on those constructs. Higher scores indicate a stronger impact on those constructs. A score for emotional exhaustion includes anything <27, a low score is 0-18. For Depersonalisation a high score is anything >10 and a low score is 0-5. For Personal accomplishment a high score is 0-33 and low score is anything >40
The Effects on Sleep
The intervention group will be asked to fill out the Epworth Sleepiness Scale survey prior to intervention starting, 30 days after start of intervention and then again at 90 days after start of intervention). The scores will be analyzed to determine impact on sleep. Lower scores indicate a normal range of sleepiness, higher scores (18-24) will be indicative of severe sleepiness. Lower scores of 0-10 will be indicative of a normal range of sleepiness in healthy adults.
The effects on Anxiety and Depression
The intervention group will be asked to fill out the GAD-7 (Generalized Anxiety Disorder) questionnaire prior to intervention starting, 30 days after start of intervention and then again at 90 days after start of intervention. The scores will be analyzed to determine impact on anxiety and depression. Lower versus higher scores will be proportional to how much anxiety and depression that person is facing. A score of 0-4 is indicative of minimal anxiety and a score of > 15 is indicative of severe anxiety.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05605041
Brief Title
Mindfulness in Medical Training
Acronym
MiMT
Official Title
Mindfulness in Medical Training: Using Headspace to Improve Sleep, Anxiety, and Burnout Among Resident Physicians
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Headspace, a smartphone application that provides guided meditation, mindfulness and sleep exercises, will be used as the intervention in improving sleep, anxiety, depression and burnout in all participating individuals selected from the University of Arizona College of Medicine-Tucson residents and fellows.
Detailed Description
The intervention of of daily meditation with the Headspace application will be used to determine if this is a possible effective intervention for decreasing the feeling of burnout. It is being proposed that it could improve the subjects' well-being both in the short-term and long term. The primary outcomes will be burnout, anxiety, depression and sleep. This study will use the Maslach Burnout Inventory to assess baseline burnout, as well as at 30 and 90 days post-intervention period. Sleep and anxiety and depression will be assessed using the Epworth Sleepiness Scale and Hospital Anxiety and Depression Scale (HADS) scores at the same intervals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mindfulness, Burnout, Anxiety, Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Did Not Use Headspace
Arm Type
No Intervention
Arm Description
Those that did not use headspace during the time the study is conducted
Arm Title
Did Use Headspace
Arm Type
Experimental
Arm Description
Those that were randomized into the group and used Headspace at least once during the study period
Intervention Type
Device
Intervention Name(s)
Headspace
Intervention Description
Headspace is an app that allows users to practice mindfulness through guided meditation
Primary Outcome Measure Information:
Title
The Effects on Burnout
Description
The intervention group will be asked to fill out the Maslachs Burnout Inventory (MBI) survey prior to intervention starting, 30 days after start of intervention and then again at 90 days after start of intervention). the MBI is a measure of three independent constructs - emotional exhaustion, depersonalization, and personal accomplishment. Lower scores will indicate less of an impact on those constructs. Higher scores indicate a stronger impact on those constructs. A score for emotional exhaustion includes anything <27, a low score is 0-18. For Depersonalisation a high score is anything >10 and a low score is 0-5. For Personal accomplishment a high score is 0-33 and low score is anything >40
Time Frame
30-90 days
Title
The Effects on Sleep
Description
The intervention group will be asked to fill out the Epworth Sleepiness Scale survey prior to intervention starting, 30 days after start of intervention and then again at 90 days after start of intervention). The scores will be analyzed to determine impact on sleep. Lower scores indicate a normal range of sleepiness, higher scores (18-24) will be indicative of severe sleepiness. Lower scores of 0-10 will be indicative of a normal range of sleepiness in healthy adults.
Time Frame
30-90 days
Title
The effects on Anxiety and Depression
Description
The intervention group will be asked to fill out the GAD-7 (Generalized Anxiety Disorder) questionnaire prior to intervention starting, 30 days after start of intervention and then again at 90 days after start of intervention. The scores will be analyzed to determine impact on anxiety and depression. Lower versus higher scores will be proportional to how much anxiety and depression that person is facing. A score of 0-4 is indicative of minimal anxiety and a score of > 15 is indicative of severe anxiety.
Time Frame
30-90 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
University of Arizona resident or fellow
Exclusion Criteria:
none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Nakajima, DO
Phone
5416478441
Email
natalia.nakajima@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Noah Tolby, MD
Phone
520-626-6312
Email
ntolby@email.arizona.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Mindfulness in Medical Training
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