Neuropattern™ for Workplace Health Promotion

NCT01331759 | Completed DMC

• 1 other identifier: LF1-2010
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress-Related Disorder

Keywords

Burnout; Subthreshold Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (5)

• quality of life

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

• severity of symptoms

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

• scores in the Maslach Burnout Inventory (MBI)

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

• scores in the Effort-Reward Imbalance Questionnaire (ERI)

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

• exploring the frequency and combinations of neuropattern in a population with high demands at work

  after the Neuropattern™ diagnosis is generated, approximately one month after study inclusion

Study Arms (2)

Immediate Neuropattern™

EXPERIMENTAL

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

Device: Neuropattern™

Later Neuropattern™

PLACEBO COMPARATOR

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

Device: Neuropattern™

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.

Also known as: Stress Diagnostics, Translational Medicine

Immediate Neuropattern™; Later Neuropattern™

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daacro: lead
• University of Trier: collaborator

Study Sites (1)

DAaCRO GmbH & Co. KG

Trier, Rhineland-Palatinate, D - 54296, Germany

Location

Related Publications (1)

• Hellhammer, D. H., & Hellhammer, J. (2008). Stress- The Brain-Body Connection (Vol. 174). Basel: Karger.

  BACKGROUND

Related Links

• DAaCRO homepage
• Homepage of the University of Trier

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Juliane Hellhammer, MSc

  Daacro GmbH & Co. KG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 8, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

DE (1)