Neuropattern™ for Workplace Health Promotion

Daacro

Status: Completed

Conditions: Stress-Related Disorder

Treatments: Device: Neuropattern™

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01331759

LF1-2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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79 participants in 2 patient groups, including a placebo group

Immediate Neuropattern™

Experimental group

Description:

The experimental group will undergo Neuropattern™ stress diagnostics immediately after inclusion in the study.

Treatment:

Device: Neuropattern™

Later Neuropattern™

Placebo Comparator group

Description:

The control group will undergo Neuropattern™ stress diagnostics three months after inclusion in the study.

Treatment:

Device: Neuropattern™