NCT01331759

Neuropattern™ for Workplace Health Promotion

Neuropattern™ Stress Diagnostics in Workplace Health Promotion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Daacro · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Stress-Related Disorder

Interventions

Type	Name	Description
DEVICE	Neuropattern™	Neuropattern™ is a diagnostic tool aiming at measuring states of activity and reactivity of interfaces involved in the communication between the brain and peripheral bodily organs in stressful situations. The concept of Neuropattern™ assumes the states of the various interfaces to be describable by characteristic patterns of simultaneous activation of biological, psychological and symptomatic variables. Neuropattern™ assesses endophenotypes through the medical history, various questionnaires for the patient or study subject, analyses of saliva cortisol and the heart rate variability and derives hypotheses on recommendations for an effective and efficient treatment.These recommendations are based on evaluated medical and psychological therapeutic methods but specified through additional biopsychological understanding. This form of individualized therapy should reduce nonresponsiveness to therapy.

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2011-04-08
• Last updated: 2014-03-28

Locations

1 site across 1 country: Germany