search
Back to results

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
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 27, 2020
Last Updated
April 1, 2022
Sponsor
University of Alberta
search

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

Learn more about this trial

Online Wellness Intervention in Medical Students

We'll reach out to this number within 24 hrs