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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02286180
Other study ID # CF14045
Secondary ID
Status Enrolling by invitation
Phase N/A
First received November 4, 2014
Last updated November 10, 2014
Start date April 2014
Est. completion date March 2016

Study information

Verified date November 2014
Source Taichung Veterans General Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial Summary

Background and objectives:

Recently the news of intern doctors' death due to overloaded work or committing suicide has made the authorities concerned put emphasis on the mental health care of medical staffs and related policies of psychological interventions. The prefrontal lobe plays an important role in the working memory, executive function and problem-solving abilities of the brain. Currently, no neuroimaging studies investigating the impact of job stress on the prefrontal love functions in intern doctors. Functional near-infrared spectroscopy (fNIRS) measures the cortical functions of the frontotemporal regions and has been widely used as a biomarker to aid in differential diagnoses in major psychiatric illnesses in Japan. The present study will investigate impact of the job stress on brain cortical activity during a verbal fluency test (VFT) by using fNIRS.

Materials and methods:

A total of 100 participants will be recruited. Clinical measurements of mood status by Beck's Depression Inventory and Beck's Anxiety Inventory, as well as job stress by Chinese Version of the Job Content Questionnaire and the Chinese version of Copenhagen Burnout Inventory will be arranged. The relationship between clinical measurements and cortical activity during a VFT will be analyzed by Pearson's correlation. Multiple regression analysis will be applied to investigate the independent contributions of mood status and job stress.

Expected results and contributions of the study:

Job stress, depression, and anxiety are significantly negatively correlated with cortical activity of prefrontal regions. The importance of mental health of medical staffs under high job stress should be stressed.


Description:

A total of 100 intern doctors will be recruited. The data including Chinese version of Copenhagen burnout inventory, BDI, BAI, average working hours per day, and average sleeping times were acquired. They will undergo NIRS investigations to detect frontal activities during performing a verbal fluency test. The correlation between stress parameters and cortical activities were examined.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date March 2016
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- medical intern doctors who are willing to participate in the study.

Exclusion Criteria:

- with past psychiatric disease

- with history substance abuse or dependence

- with history neurological disorders or head trauma

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taichung Veterans General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary frontal cortical activities during cognitive test detecting by near infrared spectroscopy 1 day No
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