Clinical trial NCT01331759: Neuropattern™ for Workplace Health Promotion
Official title: Neuropattern™ Stress Diagnostics in Workplace Health Promotion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress-Related Disorder
Keywords: Burnout
Subthreshold Disorder
Lead sponsor: Daacro
Sponsor class: NETWORK
Collaborators: name: University of Trier
First posted: 2011-04-08
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Employees aged 18 to 65 yrs
* fluent in written and spoken German
* medical clearance by their attending physician
* signed informed consent

Exclusion Criteria:

* known intolerance to steroids
* intake of steroids or benzodiazepines
* pregnancy or lactation
* any psychiatric diseases or current psychotherapy
* acute somatic illnesses, that currently require medical treatment
* obviously unsuited as subject (lack of cognitive or verbal skills)
* arrhythmia absoluta
* decision against the intake of Dexamethasone by physician or subject (e.g. known intolerance to steroids, personal or medical reasons)
* participation in any other study

Primary outcomes:
measure: Work incapacitation will be assessed through number of absent days and medical consultations in the past three months and items recording the ability to meet the demands at work.
timeFrame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics
Secondary outcomes:
measure: quality of life
timeFrame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics
measure: severity of symptoms
timeFrame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics
measure: scores in the Maslach Burnout Inventory (MBI)
timeFrame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics
measure: scores in the Effort-Reward Imbalance Questionnaire (ERI)
timeFrame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics
measure: exploring the frequency and combinations of neuropattern in a population with high demands at work
timeFrame: after the Neuropattern™ diagnosis is generated, approximately one month after study inclusion
Other outcomes:
Locations:
city: Trier
country: Germany
facility: DAaCRO GmbH & Co. KG
state: Rhineland Palatinate
Study officials:
affiliation: Daacro GmbH & Co. KG
name: Juliane Hellhammer, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hellhammer, D. H., & Hellhammer, J. (2008). Stress- The Brain-Body Connection (Vol. 174). Basel: Karger.