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Resilience, Grit, and Stress in Medical Students

Primary Purpose

Stress, Psychological

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Process group
Sponsored by
Western University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress, Psychological focused on measuring medical students, resilience, grit, stress

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Western University of Health Science, College of Osteopathic Medicine of the Pacific - NorthwestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Process Group

Control Group

Arm Description

Medical students enrolled in the small process group, led by psychiatrist.

Medical students from the same cohorts, not enrolled in the small process group.

Outcomes

Primary Outcome Measures

Perceived Stress Scale-14
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.
Connor-Davidson Resilience Scale-25
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.
The Grit Scale
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.

Secondary Outcome Measures

Medication or diagnosis change
Change in anti-depression, anti-anxiety, or other mental health medications or diagnoses on a binary yes/no scale.

Full Information

First Posted
September 13, 2023
Last Updated
September 13, 2023
Sponsor
Western University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT06046183
Brief Title
Resilience, Grit, and Stress in Medical Students
Official Title
Outcomes of Small Group Process Work on Medical Students' Resilience, Grit, and Stress Over Multiple Cohorts
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University of Health Sciences

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
medical students, resilience, grit, stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group and intervention group who self-selects
Masking
Care Provider
Masking Description
Interventionist is blinded to which group participants are also research participants.
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Process Group
Arm Type
Experimental
Arm Description
Medical students enrolled in the small process group, led by psychiatrist.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Medical students from the same cohorts, not enrolled in the small process group.
Intervention Type
Behavioral
Intervention Name(s)
Process group
Intervention Description
The medical student process group serves as a space for students to gain increased self-awareness through guided exploration of the psychodynamic processes.
Primary Outcome Measure Information:
Title
Perceived Stress Scale-14
Description
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.
Time Frame
34 weeks
Title
Connor-Davidson Resilience Scale-25
Description
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.
Time Frame
34 weeks
Title
The Grit Scale
Description
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.
Time Frame
34 weeks
Secondary Outcome Measure Information:
Title
Medication or diagnosis change
Description
Change in anti-depression, anti-anxiety, or other mental health medications or diagnoses on a binary yes/no scale.
Time Frame
34 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edie Sperling, DPT
Phone
5412590229
Email
esperling@westernu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mandi Hudson, DO
Phone
541-259-0200
Email
hudsonm@westernu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edie Sperling, DPT
Organizational Affiliation
Western University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western University of Health Science, College of Osteopathic Medicine of the Pacific - Northwest
City
Lebanon
State/Province
Oregon
ZIP/Postal Code
97355
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edie Sperling, DPT
Phone
541-259-0229
Email
esperling@westernu.edu
First Name & Middle Initial & Last Name & Degree
Mandi Hudson, DO
Phone
5412590200
Email
hudsonm@westernu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Resilience, Grit, and Stress in Medical Students

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