- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06046183
Resilience, Grit, and Stress in Medical Students
September 13, 2023 updated by: Edie Sperling, Western University of Health Sciences
Outcomes of Small Group Process Work on Medical Students' Resilience, Grit, and Stress Over Multiple Cohorts
The incidence of burnout and mental ill-health begins very early in medical school and continues to be high throughout training.
Medical students are under high amounts of stress, which often becomes chronic, and can lead to both physical and psychological issues as a student, resident, and physician.
Chronic stress and burnout in medical students are not a new phenomenon, but recent research has highlighted the worsening mental health of medical students, with as high as three-quarters of students reporting mental ill-health.
It is vital that ways are found to reduce burnout and assist in improving the mental health of medical students.
This quasi-experimental study is an ongoing study which is enrolling cohorts of students as they enter medical school.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The investigators will assess the effects of a year-long small process group intervention, led by a psychiatrist, which aims to improve self-awareness, mindfulness, and resilience in first and second-year medical students.
Students self-select into the process group, and a similar number are randomly recruited as controls from the rest of the preclinical student body.
The psychiatrist is blinded to student participation in the study.
Students in the process and control groups will be surveyed with the Perceived Stress Scale, the Connor-Davidson Resilience Scale, and the Grit Scale in September 2023, and again after nine months and 25 sessions, in May 2024, after the academic year.
Statistical analysis will be done with R Studio.
Bandura's theory of self-efficacy was used to conceptualize the study.
Recruitment is done by email, as is data collection.
The intervention includes guided exploration of the psychodynamic process, group dynamic theory, cognitive behavioral therapy, dialectical behavioral therapy, boundaries, and empathy.
Study Type
Interventional
Enrollment (Estimated)
30
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 Contact
- Name: Edie Sperling, DPT
- Phone Number: 5412590229
- Email: esperling@westernu.edu
Study Contact Backup
- Name: Mandi Hudson, DO
- Phone Number: 541-259-0200
- Email: hudsonm@westernu.edu
Study Locations
-
-
Oregon
-
Lebanon, Oregon, United States, 97355
- Recruiting
- Western University of Health Science, College of Osteopathic Medicine of the Pacific - Northwest
-
Contact:
- Edie Sperling, DPT
- Phone Number: 541-259-0229
- Email: esperling@westernu.edu
-
Contact:
- Mandi Hudson, DO
- Phone Number: 5412590200
- Email: hudsonm@westernu.edu
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- The participant must be an enrolled student at the College of Osteopathic Medicine of the Pacific-NW
- Participant must be in their first or second year of medical school
- Participant must be at least 18 years of age
- Participant must self-select into either the intervention group or control group
- Participant must sign informed consent
Exclusion Criteria:
- Data will be excluded if a student goes on a LOA during the course of the year
- Data will be excluded if a student does not attend a minimum of 12 out of 25 small group sessions
- Student does not give informed consent
- Student withdraws consent at any time
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: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Process Group
Medical students enrolled in the small process group, led by psychiatrist.
|
The medical student process group serves as a space for students to gain increased self-awareness through guided exploration of the psychodynamic processes.
|
No Intervention: Control Group
Medical students from the same cohorts, not enrolled in the small process group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale-14
Time Frame: 34 weeks
|
Stress measured on a 0-56 scale; higher number means more stress.
Each of the 14 questions is measured on a 0-4 scale of 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often.
|
34 weeks
|
Connor-Davidson Resilience Scale-25
Time Frame: 34 weeks
|
Resilience is measured on this 25-item scale, with higher numbers meaning more resilience.
The score can range between 0 and 100.
Each item has anchors from 0-4.
|
34 weeks
|
The Grit Scale
Time Frame: 34 weeks
|
The original 12-item grit scale was used to measure grit; each items is rated 1-5, then scores are summed and divided by 12, so the final score is between 1-5.
Higher scores mean more grit.
|
34 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication or diagnosis change
Time Frame: 34 weeks
|
Change in anti-depression, anti-anxiety, or other mental health medications or diagnoses on a binary yes/no scale.
|
34 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Edie Sperling, DPT, Western University of Health Sciences
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)
September 13, 2023
Primary Completion (Estimated)
May 30, 2024
Study Completion (Estimated)
May 30, 2024
Study Registration Dates
First Submitted
September 13, 2023
First Submitted That Met QC Criteria
September 13, 2023
First Posted (Actual)
September 21, 2023
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 13, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1902099-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All anonymized demographic and outcome data will be shared in an open-access data repository.
IPD Sharing Time Frame
Data will be available after being received and cleaned after the second timepoint in May 2024
IPD Sharing Access Criteria
Data will be open access
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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