Online Wellness Intervention in Medical Students

April 1, 2022 updated by: University of Alberta

Assessing the Effectiveness of a 12-week Online Wellness Intervention in Medical Students: a Pre-Post Single-arm Interventional Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mind-body Intervention arm
Online yoga, meditation and nutrition tips.
Behavioral: Mind-body therapy
Online yoga, meditation and nutrition tips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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
12 weeks
Five Facet Mindfulness Questionnaire
Time Frame: 12 weeks
Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2020

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

October 27, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00098576

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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