Online Wellness Intervention in Medical Students

Sponsor
University of Alberta (Other)
Overall Status
Completed
CT.gov ID
NCT04612387
Collaborator
(none)
65
1
1
6.1
10.6

Study Details

Study Description

Brief Summary

Medical students are at high risk of stress. This project will test how well a 12-week stress reduction program works to reduce stress, anxiety and depression and improve well-being. The program is delivered online and each week is made of an introduction video, 7-8 minutes of yoga, 5-7 minutes of meditation and nutrition tips. At the beginning and the end of the 12-week research study, we will be using surveys to ask students about their stress, anxiety, depression, sense of control over their own life, quality of life, and pain levels. After the program, the research team will conduct interviews with the medical student to allow them to share their other feedback about the program. The researchers will also send surveys to the medical students one month after the program ends to asses their continued satisfaction with and adherence to the program.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mind-body therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Assessing the Effectiveness of a 12-week Online Wellness Intervention in Medical Students: a Pre-Post Single-arm Interventional Study
Actual Study Start Date :
Oct 25, 2020
Actual Primary Completion Date :
Jan 31, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mind-body Intervention arm

Online yoga, meditation and nutrition tips.

Behavioral: Mind-body therapy
Online yoga, meditation and nutrition tips.

Outcome Measures

Primary Outcome Measures

  1. Perceived Stress Scale [12 weeks]

    The degree to which situations in one's life are appraised as stressful will be assessed using the Perceived Stress Scale. The minimum score is 0, the maximum score is 40, and higher scores indicate a worse outcome.

Secondary Outcome Measures

  1. Patient Health Questionnaire (PHQ-9) [12 weeks]

    The Patient Health Questionnaire (PHQ-9) will be used to measure depression. The minimum score is 0, the maximum is 27, and higher scores indicate a worse outcome.

  2. Psychological Wellbeing Scale [12 weeks]

    The Psychological Wellbeing Scale will be sued to measure well being. Higher scores mean higher levels of psychological well-being

  3. Five Facet Mindfulness Questionnaire [12 weeks]

    Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire.

  4. Hospital Anxiety and Depression Scale (HADS) [12 weeks]

    Depression and anxiety will be measured on the Hospital Anxiety and Depression Scale. The minimum value is 0, the maximum is 21, and higher scores mean a worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Medical students in any year of medical school
Exclusion Criteria:
  • Hospital Anxiety and Depression Scale (HADS) Depression score >10

  • Active psychosis

  • Post-traumatic stress disorder or frequent suicidal ideation

  • Major medical co-morbidity

  • Inability to provide written informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alberta Edmonton Alberta Canada T6G 2C8

Sponsors and Collaborators

  • University of Alberta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Alberta
ClinicalTrials.gov Identifier:
NCT04612387
Other Study ID Numbers:
  • Pro00098576
First Posted:
Nov 3, 2020
Last Update Posted:
Apr 5, 2022
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022