Neuropattern™ for Workplace Health Promotion

Daacro79 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Stress-Related Disorder

Interventions

Neuropattern™DEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

DAaCRO GmbH & Co. KG

Trier, Rhineland-Palatinate, Germany

Outcomes

Primary Outcomes

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.

Within-subject differences in work incapacitation will be recorded at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics, between-subject differences in work incapacitation of the Neuropattern™ group and the control group will be assessed.

Time frame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics

Secondary Outcomes

quality of life

Subjects' quality of life will be recorded at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics allowing changes to be assessed and the Neuropattern™ group will be compared to control group.

Time frame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics

severity of symptoms

The severity of symptoms will be recorded at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics. The Neuropattern™ group will be compared to the control group and changes within subjects over time will be analyzed.

Time frame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics

scores in the Maslach Burnout Inventory (MBI)

MBI scores will be recorded at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics. Changes within subjects will be analyzed and the Neuropattern™ group will be compared to the control group.

Time frame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics

scores in the Effort-Reward Imbalance Questionnaire (ERI)

ERI scores will be recorded at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics. Changes within subjects will be analyzed and the Neuropattern™ group will be compared to the control group.

Data from ClinicalTrials.gov

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