Stress-Related DisorderNCT01331759
Neuropattern™ for Workplace Health Promotion
A study testing Neuropattern™ in people with Stress-Related Disorder, run by Daacro at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress-Related Disorder
- What is being tested?
- Neuropattern™
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employees aged 18 to 65 yrs
- fluent in written and spoken German
- medical clearance by their attending physician
- signed informed consent
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Neuropattern™ Stress Diagnostics in Workplace Health Promotion
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.
Read the 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.
- Conditions
- Stress-Related Disorder
- Being tested
- Neuropattern™
- Keywords
- Burnout, Subthreshold Disorder
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropattern™Device
Also called Stress Diagnostics, Translational Medicine
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Neuropattern™ | Experimental | The experimental group will undergo Neuropattern™ stress diagnostics immediately after inclusion in the study. Receives: Device: Neuropattern™ |
| Later Neuropattern™ | Placebo comparator | The control group will undergo Neuropattern™ stress diagnostics three months after inclusion in the study. Receives: Device: Neuropattern™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: after the Neuropattern™ diagnosis is generated, approximately one month after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress-Related DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daacro
- Sponsor type
- Research network
- Collaborators
- University of Trier
- Responsible party
- Principal investigator, Juliane Hellhammer, Daacro
- Investigators
- Juliane Hellhammer, MSc, Principal investigator, Daacro GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331759
- Sponsor's protocol ID
- LF1-2010
- Status last verified
- Mar 2014
- First submitted
- 1 Apr 2011
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hellhammer, D. H., & Hellhammer, J. (2008). Stress- The Brain-Body Connection (Vol. 174). Basel: Karger.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropattern™ Stress Diagnostics in Workplace Health Promotion
- ClinicalTrials.gov ID
- NCT01331759
- Acronym / sponsor ID
- LF1-2010
- Conditions
- Stress-Related Disorder
- Keywords
- Burnout, Subthreshold Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- DaacroResearch network
- Collaborators
- University of Trier
- Study start
- Jan 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Neuropattern™ | Experimental | Device: Neuropattern™The experimental group will undergo Neuropattern™ stress diagnostics immediately after inclusion in the study. |
| Later Neuropattern™ | Placebo comparator | Device: Neuropattern™The control group will undergo Neuropattern™ stress diagnostics three months after inclusion in the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Employees aged 18 to 65 yrs
- fluent in written and spoken German
- medical clearance by their attending physician
- signed informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropattern™Also: Stress Diagnostics, Translational MedicineNeuropattern™ 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. | Device | Immediate Neuropattern™, Later Neuropattern™ |
Primary outcome
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
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.
5 secondary outcomes
quality of life
Time frame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics
severity of symptoms
Time frame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics
scores in the Maslach Burnout Inventory (MBI)
Time frame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics
scores in the Effort-Reward Imbalance Questionnaire (ERI)
Time frame: 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
Time frame: after the Neuropattern™ diagnosis is generated, approximately one month after study inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
- BackgroundHellhammer, D. H., & Hellhammer, J. (2008). Stress- The Brain-Body Connection (Vol. 174). Basel: Karger.
- DAaCRO homepageLink provided by the sponsor.
- Homepage of the University of TrierLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliane Hellhammer, MSc principal investigator
Daacro GmbH & Co. KG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropattern™ in people with Stress-Related Disorder, run by Daacro at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: at study inclusion as well as 3 and 6 months after Neuropattern™ stress diagnostics). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01331759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2014.