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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06046183
Other study ID # 1902099-2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 13, 2023
Est. completion date May 30, 2024

Study information

Verified date September 2023
Source Western University of Health Sciences
Contact Edie Sperling, DPT
Phone 5412590229
Email esperling@westernu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: 1. The participant must be an enrolled student at the College of Osteopathic Medicine of the Pacific-NW 2. Participant must be in their first or second year of medical school 3. Participant must be at least 18 years of age 4. Participant must self-select into either the intervention group or control group 5. Participant must sign informed consent Exclusion Criteria: 1. Data will be excluded if a student goes on a LOA during the course of the year 2. Data will be excluded if a student does not attend a minimum of 12 out of 25 small group sessions 3. Student does not give informed consent 4. Student withdraws consent at any time

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Western University of Health Science, College of Osteopathic Medicine of the Pacific - Northwest Lebanon Oregon

Sponsors (1)

Lead Sponsor Collaborator
Western University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Medication or diagnosis change Change in anti-depression, anti-anxiety, or other mental health medications or diagnoses on a binary yes/no scale. 34 weeks
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