Stress-Related Disorder Clinical Trial
Official title:
Neuropattern™ Stress Diagnostics in Workplace Health Promotion
Neuropattern™, a new diagnostic tool for stress related disorders is being applied in a demanding workplace environment. Neuropattern™ aims at identifying stress-related bodily changes at an early stage. By identifying subgroups based on Neuropattern™ subjects gain access to online counseling specified according to their Neuropattern™ diagnosis. Efficacy is being assessed by several questionnaires in a follow-up.
100 employees of a company in Rhineland Palatinate employing approximately 2100 persons will
be recruited.
This is a randomized, two-armed single center study. Persons interested in study
participation receive a Neuropattern™ voucher according to occupational group together with
other documents. As soon as the documents (signed informed consent, evaluation form, ERI,
MBI, demographic questionnaire and the form for designation of the attending physician) are
returned, the study manager contacts the employee and either tells him/ her that an
appointment with the designated physician should be made within the following week
(Neuropattern™ group) or that there will be a three months wait (control group). The employee
attends the medical appointment with the designated physician and documents sent to the
physician beforehand (NPQ-A, medical clearance form and prescription form for Dexamethasone)
are completed. Upon return of these documents, the Neuropattern™ test kit (including the
questionnaires NPQ-P, NPQ-PSQ, NPQ-S and PHQ as well as 16 Salivettes® for saliva sample
collection, 0.25 mg Dexamethasone and a portable ECG device) is shipped to the subject and
Neuropattern™ is conducted at home. After return of the test kit to DAaCRO, the subject is
assigned to neuropattern and will gain access to individualized online counseling for three
months. Evaluation (including an evaluation form, ERI and MBI) will take place at baseline as
well as three and six months after onset of online counseling for assessment of efficacy.
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