Stress, PsychologicalNCT06046183
Resilience, Grit, and Stress in Medical Students
A study testing Process group in people with Stress, Psychological, run by Western University of Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Process group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Western University of Health Science, College of Osteopathic Medicine of the Pacific - Northwest
Lebanon, Oregon, 97355
Edie Sperling, DPT, 541-259-0229, esperling@westernu.edu
Mandi Hudson, DO, 5412590200, hudsonm@westernu.edu
About this study
Official title: Outcomes of Small Group Process Work on Medical Students' Resilience, Grit, and Stress Over Multiple Cohorts
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.
Read the 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.
- Conditions
- Stress, Psychological
- Being tested
- Process group
- Keywords
- medical students, resilience, grit, stress
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Process groupBehavioural
The medical student process group serves as a space for students to gain increased self-awareness through guided exploration of the psychodynamic processes.
| Study group | Role | What they receive |
|---|---|---|
| Process Group | Experimental | Medical students enrolled in the small process group, led by psychiatrist. Receives: Behavioral: Process group |
| Control Group | No intervention | Medical students from the same cohorts, not enrolled in the small process group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 34 weeks
Secondary outcomes (1)
Medication or diagnosis change
Change in anti-depression, anti-anxiety, or other mental health medications or diagnoses on a binary yes/no scale.
Measured: 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start13 Sep 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Control group and intervention group who self-selects
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edie Sperling, Western University of Health Sciences
- Investigators
- Edie Sperling, DPT, Principal investigator, Western University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046183
- Sponsor's protocol ID
- 1902099-2
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymized demographic and outcome data will be shared in an open-access data repository.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Small Group Process Work on Medical Students' Resilience, Grit, and Stress Over Multiple Cohorts
- ClinicalTrials.gov ID
- NCT06046183
- Acronym / sponsor ID
- 1902099-2
- Conditions
- Stress, Psychological
- Keywords
- medical students, resilience, grit, stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Control group and intervention group who self-selects
| Arm | Type | Receives |
|---|---|---|
| Process Group | Experimental | Behavioral: Process groupMedical students enrolled in the small process group, led by psychiatrist. |
| Control Group | No intervention | –Medical students from the same cohorts, not enrolled in the small process group. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Process groupThe medical student process group serves as a space for students to gain increased self-awareness through guided exploration of the psychodynamic processes. | Behavioural | Process Group |
Primary outcome
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.
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.
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.
1 secondary outcome
Medication or diagnosis change
Time frame: 34 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Yes. All anonymized demographic and outcome data will be shared in an open-access data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edie Sperling, DPT principal investigator
Western University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Process group in people with Stress, Psychological, run by Western University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edie Sperling, DPT (5412590229, esperling@westernu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale-14 (time frame: 34 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.