Intern Health Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01809080|
Recruitment Status : Enrolling by invitation
First Posted : March 12, 2013
Last Update Posted : August 28, 2018
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||4380 participants|
|Official Title:||Investigation Into the Interaction Between Genes and Stress in the Etiology of Depression in Interns|
|Study Start Date :||May 2007|
|Estimated Primary Completion Date :||July 2027|
|Estimated Study Completion Date :||July 2027|
- Assess the change in rates of depression among medical interns. [ Time Frame: Months 0, 3, 6, and 12 of Intern Year ]The point prevalence of depression at various points through internship will be determined using subject responses to DSM-IV major depression items at the 0, 3-month, 6-month and 12-month assessments. To investigate whether there is a significant change in depressive symptoms through intern year, the investigators will compare PHQ (baseline) and PHQ (6 month) depression scores through a paired T-test. The effect of baseline psychological traits (neuroticism, resilience, personal history of depression, family history of depression, early family environment, social supports) on the development of depression will also be explored through linear regression analyses with each of the psychological factors as independent variables and PHQ (change) [PHQ (6 month) - PHQ (baseline)] as the dependent variable. The investigators will use linear regression to investigate correlations between training program characteristics (average work hours, specialty) and PHQ (change).
- Evaluate the presence of genotype x stress interaction among this sample. [ Time Frame: Sample within first 6 months of Intern Year (Because DNA sequence generally does not change with time, the exact timing of sample collection is not critical to the analysis) ]As a baseline analysis, the investigators will investigate association between each variant/haplotype and PHQ (baseline) scores using linear regression. To explore gene x environment interactions, the investigators will assess for association between each variant/haplotype and PHQ change scores (Mean (3,6,9 and 12 month PHQ score) - Baseline (PHQ score)).
- Evaluate the relationship between serum factors and changes in depressive symptoms under stress. [ Time Frame: Months 0 and 10 of Intern Year ]For each of the proteins assessed (IL-1beta, IL-6, IL-10, hs-CRP and TNF-alpha), Pearson correlation will be used to assess the relationship between serum and saliva levels. The investigators will assess whether there is a significant change in the serum levels of endothelial and inflammatory markers and endothelial function using a within-subject paired T-test, with baseline values (low stress) paired with internship stress values (high stress). To assess whether the change in endothelial and inflammatory markers correlate with a change in depressive symptoms, the investigators will utilize a linear regression, with the change in marker level used as explanatory variables and the change in depressive symptoms score (PHQ (change) = mean residency depressive symptoms - baseline depressive symptoms) used as the outcome variable
- Examine the temporal relationship between hair cortisol level changes, stress exposure and changes in depressive symptoms [ Time Frame: Months 0, 4, 8, 12 of Intern Year ]Statistical analysis will be conducted using Generalized Estimating Equation (GEE) analysis. To assess whether there is a change in hair cortisol indices with internship stress, the investigators will perform a paired T-test, with pre-internship factor cortisol level paired with post-internship factor cortisol level. To determine the relationship between hair-related factors (hair color, hair treatment, washing frequency), transient mediating factors (work hours, outside stressful life events, recent exercise, sleep and illness), long-term mediating factors (BMI, regular exercise schedule, smoking behavior) and long-term cortisol, the investigators will assess whether the difference in level of these factors between the two assessments shows a significant correlation with the difference in cortisol level. Next, the investigators will identify whether that change in hair cortisol is associated with the change in depressive symptoms while accounting for related variables.
Biospecimen Retention: Samples With DNA
Saliva: DNA collection kits are sent via postal mail and participants are asked to provide a small sample of saliva.
Blood samples (up to 50 mL via venopuncture): whole blood and serum will be assessed.
Hair: The total diameter taken from the scalp's posterior vertex will be about 3 mm, which is about half of the diameter of pencil (approximately 100 hair strands with a minimum of 50 mg of hair for a 3-cm segment).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809080
|United States, Michigan|
|University of Michigan Medical School|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Srijan Sen, MD, PhD||University of Michigan|