An interventional study of Process group in Stress, Psychological, sponsored by Western University of Health Sciences. Status unknown at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Western University of Health Sciences · Not applicable, Interventional, and Supportive care
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.
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.
806 studies on the registry are indexed under Stress, Psychological; 131 are open to participants now.
This study's planned enrollment of 30 is below the median of 84 across 651 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →Western University of Health Sciences is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Medical students enrolled in the small process group, led by psychiatrist.
Behavioral: Process group
Medical students from the same cohorts, not enrolled in the small 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 34 weeks
Medication or diagnosis change
Change in anti-depression, anti-anxiety, or other mental health medications or diagnoses on a binary yes/no scale.
Time frame: 34 weeks
Plan to share: Yes — All anonymized demographic and outcome data will be shared in an open-access data repository.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for May 2024, 8 months after the start.
Of 444 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 8 months is below that.
Counting every sponsor, half of 456 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Western University of Health Sciences