Intern Health Study

NCT ID: NCT01809080

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

25000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2027-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Retrospective studies have established a strong correlation between reports of life stress and depression. Investigators have begun to further explore this relationship by examining the role of gene x stress interactions in the pathogenesis of depression. In a recent landmark study, Caspi and colleagues (2003) reported an interaction between a serotonin transporter promoter polymorphism and life stress in the development of depression. This finding has been replicated in some but not all follow up studies. Despite the initial promise of these results, the ability to draw definitive conclusions is compromised by significant study design limitations: 1) retrospective design 2) a focus on acute rather than chronic stress 3) substantial variation in the character and intensity of stress between subjects. Medical internship is a period filled with predictable and high levels of chronic uncontrolled stress. Rates of depression among interns are elevated compared to the general population. In this study, we aim to utilize the predictable and consistent stress of internship to investigate the relationship between stress, genes and depression with a prospective study design that bypasses some of the pitfalls of previous studies.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Specific Aims Retrospective studies have established a strong correlation between reports of life stress and depression. Investigators have begun to further explore this relationship by examining the role of gene x stress interactions in the pathogenesis of depression. In a recent landmark study, Caspi and colleagues (2003) reported an interaction between a serotonin transporter promoter polymorphism and life stress in the development of depression. This finding has been replicated in some but not all follow up studies. Despite the initial promise of these results, the ability to draw definitive conclusions is compromised by significant study design limitations: 1) retrospective design 2) a focus on acute rather than chronic stress 3) substantial variation in the character and intensity of stress between subjects. Medical internship is a period filled with predictable and high levels of chronic uncontrolled stress. Rates of depression among interns are elevated compared to the general population. In this study, we aim to utilize the predictable and consistent stress of internship to investigate the relationship between stress, genes and depression with a prospective study design that bypasses some of the pitfalls of previous studies.

Goal 1) Assess the prevalence and development of depression among medical interns

Although small studies have assessed the point prevalence of depression among medical residents, no study has prospectively followed the development of depressive symptoms through residency. We will collect baseline psychological profiles of incoming interns prior to the commencement of residency duties and subsequently assess for depressive symptoms at 3-month intervals throughout internship. This data will allow us to:

1. Assess the point prevalence of depression among interns in a large sample.
2. Determine the change in depressive symptoms through the course of the intern year
3. Evaluate stable psychological factors that associate with the development of depression in the face of life stress.

Goal 2) Evaluate the presence of genotype x stress interaction among this sample

1. There is conflicting evidence concerning the presence of an interaction between the serotonin transporter promoter polymorphism (5-HTTLPR) and life stress in the development of depression. We will assess the presence and strength of this interaction in the sample of medical interns using a study design that avoids many of the pitfalls affecting previous studies.
2. We will explore novel putative interactions between stress and genetic variants in additional genes including BDNF, CRH, COMT, serotonin 1A and serotonin 2A receptor variants in the development of depression.

Goal 3) Evaluate the relationship between serum endothelial and immune factors and the development of depressive symptoms under stress.

The identification biomarkers that predict the onset of depression can facilitate more timely and accurate identification of individuals at high risk for the disorder. Unfortunately appropriate studies are lacking, largely because it is difficult to know exactly when a depressive episode will occur. Medical internship represents a rare situation where we can prospectively predict when a cohort of individuals shift will shift from a low stress environment to a high stress environment and thus predict when this cohort will experience a dramatic increase in depressive symptoms.

Goal 4) Examine the temporal relationship between hair cortisol levels, stress exposure and development of depressive symptoms.A novel technique allows us to assess chronic HPA axis activity by measuring cortisol in the growing hair, providing an integrated measure of total cortisol secretion over extended periods of time (1-3 months).

By incorporating this novel method into an established longitudinal study of a chronic stressor that dramatically increases rates of depression, we have a unique opportunity to determine a) whether cortisol levels prior to stress exposure predict risk of depression in response to the stressor (b) whether cortisol rise in response to stress exposure precedes and perhaps contributes to development of depressive symptoms or whether cortisol elevations in depression develop after symptom onset and perhaps reflect a consequence of depression.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2020

No interventions assigned to this group

2019

No interventions assigned to this group

2018

No interventions assigned to this group

2017

No interventions assigned to this group

2016

No interventions assigned to this group

2015

No interventions assigned to this group

2014

No interventions assigned to this group

2013

No interventions assigned to this group

2012

No interventions assigned to this group

2011

No interventions assigned to this group

2010

No interventions assigned to this group

2009

No interventions assigned to this group

2008

No interventions assigned to this group

2007

No interventions assigned to this group

2021

No interventions assigned to this group

2022

No interventions assigned to this group

2023

No interventions assigned to this group

2024

No interventions assigned to this group

2025

No interventions assigned to this group

2026

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects for our study will be drawn from incoming interns in the traditional and primary care internal medicine, general surgery, pediatrics, obstetrics/gynecology, neurology and psychiatry residency programs at participating University and Community residency programs, as well as fourth year medical students at participating medical schools.

Exclusion Criteria

* None.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Srijan Sen

Assistant Professor of Psychiatry, Medicial School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Srijan Sen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan Medical School

Ann Arbor, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Karg K, Sen S. Gene x environment interaction models in psychiatric genetics. Curr Top Behav Neurosci. 2012;12:441-62. doi: 10.1007/7854_2011_184.

Reference Type BACKGROUND
PMID: 22241248 (View on PubMed)

Guille C, Sen S. Prescription drug use and self-prescription among training physicians. Arch Intern Med. 2012 Feb 27;172(4):371-2. doi: 10.1001/archinternmed.2011.791. No abstract available.

Reference Type BACKGROUND
PMID: 22371930 (View on PubMed)

Guille C, Speller H, Laff R, Epperson CN, Sen S. Utilization and barriers to mental health services among depressed medical interns: a prospective multisite study. J Grad Med Educ. 2010 Jun;2(2):210-4. doi: 10.4300/JGME-D-09-00086.1.

Reference Type BACKGROUND
PMID: 21975622 (View on PubMed)

Sen S, Kranzler HR, Krystal JH, Speller H, Chan G, Gelernter J, Guille C. A prospective cohort study investigating factors associated with depression during medical internship. Arch Gen Psychiatry. 2010 Jun;67(6):557-65. doi: 10.1001/archgenpsychiatry.2010.41. Epub 2010 Apr 5.

Reference Type BACKGROUND
PMID: 20368500 (View on PubMed)

Karg K, Burmeister M, Shedden K, Sen S. The serotonin transporter promoter variant (5-HTTLPR), stress, and depression meta-analysis revisited: evidence of genetic moderation. Arch Gen Psychiatry. 2011 May;68(5):444-54. doi: 10.1001/archgenpsychiatry.2010.189. Epub 2011 Jan 3.

Reference Type BACKGROUND
PMID: 21199959 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MH-095109

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

IFH Depression Registry 2013
NCT01913262 UNKNOWN