NCT04612387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

April 5, 2022

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

October 27, 2020

Last Update Submit

April 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (4)

  • Patient Health Questionnaire (PHQ-9)

    12 weeks

  • Psychological Wellbeing Scale

    12 weeks

  • Five Facet Mindfulness Questionnaire

    12 weeks

  • Hospital Anxiety and Depression Scale (HADS)

    12 weeks

Study Arms (1)

Mind-body Intervention arm

EXPERIMENTAL

Online yoga, meditation and nutrition tips.

Behavioral: Mind-body therapy

Interventions

Online yoga, meditation and nutrition tips.

Mind-body Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Medical students in any year of medical school

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mind-Body Therapies

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 3, 2020

Study Start

October 25, 2020

Primary Completion

January 31, 2021

Study Completion

April 30, 2021

Last Updated

April 5, 2022

Record last verified: 2020-10

Locations