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Online Wellness Intervention in Medical Students

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ClinicalTrials.gov Identifier: NCT04612387
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Study Description
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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
Stress, Psychological Mind Body Therapy Wellbeing Behavioral: Mind-body therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 25, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : April 30, 2021
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Perceived Stress Scale [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 weeks ]
    Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire.

  4. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04612387


Contacts
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Contact: Puneeta Tandon 7804929844 ptandon@ualberta.ca

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2C8
Sponsors and Collaborators
University of Alberta
More Information
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04612387    
Other Study ID Numbers: Pro00098576
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms