NCT02286180

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 11, 2014

Status Verified

November 1, 2014

Enrollment Period

11 months

First QC Date

November 4, 2014

Last Update Submit

November 10, 2014

Conditions

Keywords

near infrared spectroscopyNIRSintern

Outcome Measures

Primary Outcomes (1)

  • frontal cortical activities during cognitive test detecting by near infrared spectroscopy

    1 day

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical Intern Doctors in a medical center

You may qualify if:

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

You may not qualify if:

  • with past psychiatric disease
  • with history substance abuse or dependence
  • with history neurological disorders or head trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • PoHan Chou, MD

    Taichung Veterans General Hospital, Taiwan, ROC.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 7, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2016

Last Updated

November 11, 2014

Record last verified: 2014-11