- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06003920
Outcomes of a Small Process Group on Medical Students' Grit, Resilience, and Stress
August 15, 2023 updated by: Edie Sperling, Western University of Health Sciences
Outcomes of a Small Process Group on Medical Students' Grit, Resilience, and Stress: A Quasi-experimental Pilot Study
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 aimed to assess the effect of a small process group vs. a control group of preclinical medical students on their stress, resilience, and grit.
Study Overview
Detailed Description
The investigators assessed the effects of a year-long small process group intervention, led by a psychiatrist, which aimed to improve self-awareness, mindfulness, and resilience in first and second-year medical students.
Students self-selected into the process group, and the same number were randomly recruited as controls from the rest of the preclinical student body.
The psychiatrist who led the groups was blinded to student participation in the study.
Students in the process and control groups were surveyed with the Perceived Stress Scale, the Connor-Davidson Resilience Scale, and the Grit Scale in September 2022, and again after nine months and 25 sessions, in May 2023, after the academic year.
Statistical analysis was done with R Studio.
Bandura's theory of self-efficacy was used to conceptualize the study.
Recruitment was done by email, as was data collection.
The intervention included guided exploration of the psychodynamic process, group dynamic theory, cognitive behavioral therapy, dialectical behavioral therapy, boundaries, and empathy.
Study Type
Interventional
Enrollment (Actual)
16
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
-
-
Oregon
-
Lebanon, Oregon, United States, 97355
- College of Osteopathic Medicine of the Pacific - Northwest
-
-
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 served 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 L 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)
June 24, 2022
Primary Completion (Actual)
May 30, 2023
Study Completion (Actual)
May 30, 2023
Study Registration Dates
First Submitted
July 31, 2023
First Submitted That Met QC Criteria
August 15, 2023
First Posted (Actual)
August 22, 2023
Study Record Updates
Last Update Posted (Actual)
August 22, 2023
Last Update Submitted That Met QC Criteria
August 15, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1902099
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
Study protocol and SAP will be shared with results.
Informed consent is shared here.
IPD Sharing Access Criteria
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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