NCT06046183

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 13, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

September 13, 2023

Last Update Submit

September 13, 2023

Conditions

Keywords

medical studentsresiliencegritstress

Outcome Measures

Primary Outcomes (3)

  • 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.

    34 weeks

  • 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.

    34 weeks

  • 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.

    34 weeks

Secondary Outcomes (1)

  • Medication or diagnosis change

    34 weeks

Study Arms (2)

Process Group

EXPERIMENTAL

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

Behavioral: Process group

Control Group

NO INTERVENTION

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

Interventions

Process groupBEHAVIORAL

The medical student process group serves as a space for students to gain increased self-awareness through guided exploration of the psychodynamic processes.

Process Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lebanon, Oregon, 97355, United States

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Edie Sperling, DPT

    Western University of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edie Sperling, DPT

CONTACT

Mandi Hudson, DO

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Interventionist is blinded to which group participants are also research participants.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Control group and intervention group who self-selects
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Vice-Chair, Medical Anatomical Sciences

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

September 13, 2023

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

All anonymized demographic and outcome data will be shared in an open-access data repository.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available after being received and cleaned after the second timepoint in May 2024
Access Criteria
Data will be open access

Locations