Neuropattern™ for Workplace Health Promotion

This study has been completed.
Sponsor:
Collaborator:
University of Trier
Information provided by (Responsible Party):
Juliane Hellhammer, Daacro
ClinicalTrials.gov Identifier:
NCT01331759
First received: April 1, 2011
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Stress-Related Disorder
Device: Neuropattern™

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Neuropattern™ Stress Diagnostics in Workplace Health Promotion

Further study details as provided by Daacro:

Primary Outcome Measures:
  • 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. [ Time Frame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • quality of life [ Time Frame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics ] [ Designated as safety issue: No ]
    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.

  • severity of symptoms [ Time Frame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics ] [ Designated as safety issue: No ]
    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.

  • scores in the Maslach Burnout Inventory (MBI) [ Time Frame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics ] [ Designated as safety issue: No ]
    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.

  • scores in the Effort-Reward Imbalance Questionnaire (ERI) [ Time Frame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics ] [ Designated as safety issue: No ]
    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.

  • exploring the frequency and combinations of neuropattern in a population with high demands at work [ Time Frame: after the Neuropattern™ diagnosis is generated, approximately one month after study inclusion ] [ Designated as safety issue: No ]
    There are thirteen different neuropattern generated from biological psychological and symptomatic variables assessed by the Neuropattern™ questinnaires and the biomarkers. After the Neuropattern™ diagnosis is generated, approximately one month after study inclusion, frequency and combinations of neuropattern found in the study population will be documented as part of an evaluative and developmental process of Neuropattern™ stress diagnostics.


Enrollment: 79
Study Start Date: January 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate Neuropattern™
The experimental group will undergo Neuropattern™ stress diagnostics immediately after inclusion in the study.
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.
Other Names:
  • Stress Diagnostics
  • Translational Medicine
Placebo Comparator: Later Neuropattern™
The control group will undergo Neuropattern™ stress diagnostics three months after inclusion in the study.
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.
Other Names:
  • Stress Diagnostics
  • Translational Medicine

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331759

Locations
Germany
DAaCRO GmbH & Co. KG
Trier, Rhineland Palatinate, Germany, D - 54296
Sponsors and Collaborators
Daacro
University of Trier
Investigators
Principal Investigator: Juliane Hellhammer, MSc DAaCRO GmbH & Co. KG
  More Information

Additional Information:
No publications provided

Responsible Party: Juliane Hellhammer, MSc, Daacro
ClinicalTrials.gov Identifier: NCT01331759     History of Changes
Other Study ID Numbers: LF1-2010
Study First Received: April 1, 2011
Last Updated: March 27, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Daacro:
Burnout
Subthreshold Disorder

Additional relevant MeSH terms:
Psychophysiologic Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014