Online Wellness Intervention in Medical Students
Primary Purpose
Stress, Psychological, Mind Body Therapy, Wellbeing
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mind-body therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Psychological
Eligibility 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
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mind-body Intervention arm
Arm Description
Online yoga, meditation and nutrition tips.
Outcomes
Primary Outcome Measures
Perceived Stress Scale
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
Patient Health Questionnaire (PHQ-9)
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.
Psychological Wellbeing Scale
The Psychological Wellbeing Scale will be sued to measure well being. Higher scores mean higher levels of psychological well-being
Five Facet Mindfulness Questionnaire
Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire.
Hospital Anxiety and Depression Scale (HADS)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04612387
Brief Title
Online Wellness Intervention in Medical Students
Official Title
Assessing the Effectiveness of a 12-week Online Wellness Intervention in Medical Students: a Pre-Post Single-arm Interventional Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 25, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Mind Body Therapy, Wellbeing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mind-body Intervention arm
Arm Type
Experimental
Arm Description
Online yoga, meditation and nutrition tips.
Intervention Type
Behavioral
Intervention Name(s)
Mind-body therapy
Intervention Description
Online yoga, meditation and nutrition tips.
Primary Outcome Measure Information:
Title
Perceived Stress Scale
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
12 weeks
Title
Psychological Wellbeing Scale
Description
The Psychological Wellbeing Scale will be sued to measure well being. Higher scores mean higher levels of psychological well-being
Time Frame
12 weeks
Title
Five Facet Mindfulness Questionnaire
Description
Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire.
Time Frame
12 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
12. IPD Sharing Statement
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Online Wellness Intervention in Medical Students
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