Online Mindfulness for Medical Trainees

NCT04497909 | Terminated

• 1 other identifier: Pro00103222
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Medical students and medical residents are subject to increased stressors throughout their education. There is increased depression, anxiety, burnout, and distress in medical trainees compared to the general population. Globally, roughly 3 out of 10 medical students experience anxiety. A recent study also found that almost 3 out of 10 medical trainees experience depression or depressive symptoms and approximately 1 out of 10 have suicidal thoughts. All of this leads to poorer academics, increased dropout rates as well as reduced empathy and quality of care in affected trainees. Mindfulness programs are increasingly being used in medical schools to help deal with increased levels of depression, anxiety, stress, and burnout. Several studies have looked at medical students, medical residents, and various other healthcare professionals. These programs have been found to reduce depression, anxiety and stress while significantly improving mood, well being and mindfulness. Although in-person mindfulness programs have shown several benefits, there are limitations to its use in medical programs. A lack of time, flexibility, accessibility as well as the issue of cost, impact the uptake of in-person mindfulness programs. A potential alternative to this is online mindfulness programs. To date, there is limited research regarding medical students and online mindfulness programs. With that being said, studies focussed on other populations and online mindfulness have shown reductions in depression, anxiety and stress with improvements in mindfulness and mood. The study being proposed involves providing online mindfulness to medical students and residents in an 8-week program that consists of 8, 1-hour sessions with a mindfulness coach. Participants will be enrolled through informed consent. All participants will be given pre and post participation questionnaires to examine the impact of online mindfulness on anxiety, depression, stress and burnout. The results of this research may lead to future studies looking at the impact of online mindfulness practice for medical trainees and might also help open up the possibility of offering such programs in medical schools.

Conditions

Stress; Anxiety; Depression; Mindfulness

Keywords

Mindfulness; Medical Students; Medical Residents; Medical Trainees

Outcome Measures

Primary Outcomes (10)

• Change in stress symptoms time 1

  using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.

  Change from recruitment to immediately after the online mindfulness course

• Change in stress symptoms time 2

  using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.

  Change from recruitment to 3 months after the online mindfulness course

• Change in anxiety symptoms time 1

  using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of anxiety symptoms. Minimum score is 0. Maximum score is 21.

  Change from recruitment to immediately after the online mindfulness course

• Change in anxiety symptoms time 2

  using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of anxiety symptoms. Minimum score is 0. Maximum score is 21.

  Change from recruitment to 3 months after the online mindfulness course

• Change in depression symptoms time 1

  using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.

  Change from recruitment to immediately after the online mindfulness course

• Change in depression symptoms time 2

  using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.

  Change from recruitment to 3 months after the online mindfulness course

• Change in burnout symptoms time 1

  using the Oldenburg Burnout Inventory for Students; a 16 item scale to measure burnout. Scores for individual question range from 1 (strongly disagree) to 4 (strongly agree). A high score means a higher level of burnout symptoms. This scale has 2 subscales. Minimum score is 8. Maximum score is 32 for both subscales.

  Change from recruitment to immediately after the online mindfulness course

• Change in burnout symptoms time 2

  using the Oldenburg Burnout Inventory for Students; a 16 item scale to measure burnout. Scores for individual question range from 1 (strongly disagree) to 4 (strongly agree). A high score means a higher level of burnout symptoms. This scale has 2 subscales. Minimum score is 8. Maximum score is 32 for both subscales.

  Change from recruitment to 3 months after the online mindfulness course

• Change in mindful awareness time 1

  using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90. And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale. A high score in both scales (and subscales)means a high mindful awareness level.

  Change from recruitment to immediately after the online mindfulness course

• Change in mindful awareness time 2

  using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90. And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale. A high score in both scales (and subscales)means a high mindful awareness level.

  Change from recruitment to 3 months after the online mindfulness course

Secondary Outcomes (4)

• Frequency of Mindfulness practice 1

  From recruitment to the end of the online mindfulness elective (8 weeks in total)

• Duration of Mindfulness practice 1

  From recruitment to the end of the online mindfulness elective (8 weeks in total)

• Frequency of Mindfulness practice 2

  From the end of the online mindfulness elective until three months after

• Duration of Mindfulness practice 2

  From the end of the online mindfulness elective until three months after

Study Arms (3)

Pre-clerkship cohort

EXPERIMENTAL

First- and second-year medical students

Behavioral: Mindfulness

Clerkship cohort

EXPERIMENTAL

Third- and fourth-year medical students

Behavioral: Mindfulness

Resident cohort

EXPERIMENTAL

Medical residents

Behavioral: Mindfulness

Interventions

Mindfulness BEHAVIORAL

Mindfulness online training

Clerkship cohort; Pre-clerkship cohort; Resident cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- A medical trainee who registered for the online mindfulness elective

You may not qualify if:

• \- None

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Marc-Antoine Landry, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The three groups of participants are a pre-clerkship cohort consisting of first- and second-year medical students, a clerkship cohort consisting of third- and fourth-year medical students and the third cohort consisting of medical residents.

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 4, 2020
• Study Start: May 1, 2021
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)