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Mindfulness 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
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mindfulness, Burnout, Anxiety, Sleep

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 1, 2022
    Last Updated
    November 1, 2022
    Sponsor
    University of Arizona
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    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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