Neuropattern - Assessment of a Translational Diagnostic Tool for Depression, Adjustment- and Somatoform-disorders

Study Overview
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Brief Summary
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Neuropattern is a first translational tool in stress medicine. Neuropattern is a diagnostic tool, which can be applied by in- and outpatients and physicians to detect dysregulation in the stress response network. The physician provides anamnestic and anthropometric data, while the patient takes other measures at home, e.g. psychological, symptomatic, and biological data. Among the biological data are ECG measures for analyses of heart rate variability, and salivary cortisol measures before and after a dexamethasone challenge test. All data are analyzed in a central laboratory, which generates a written report for the physician, including a disease model, from which personalized recommendations for pharmacological and psychological treatments are derived. Neuropattern additionally offers individualized internet modules to inform the patient about the disease model and to teach him/her what he/she can do to improve his/her medical conditions. The current study applies Neuropattern in 2000 patients of family doctors, suffering from major depression, depressive episodes, adjustment disorders, and somatoform disorders. The patients receive either unspecific or individualized internet modules in a randomized order.

Official Title
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Neuropattern - Clinical Trial of a Psychobiological Stress Diagnostic Tool (Neuropattern - Erprobung Einer Psychobiologischen Stressdiagnostik)

Conditions
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Major Depression, Minor Depression, Somatoform Disorders, Adjustment Disorders

Intervention / Treatment
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* Behavioral: self-guided internet modules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: native speakers ICD-F diagnoses 32, 33, 43.2, and 45 Exclusion Criteria: patients under glucocorticoid treatment patients taking antidepressants and anxiolytics patients under psychotherapeutic treatment pregnant women severe medical conditions mental retardation arrhythmia absoluta intolerance of dexamethasone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: self-guided internet modules|Patients are assigned at random to either unspecific (n= 1000) or individualized (n=1000) self guided internet modules.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation and distribution of different endophenotypes (Neuropattern) in patients of family doctors suffering from depressive episodes, major depression, somatoform disorders, and adjustment disorders |  | 15 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Neuropattern diagnostics with respect to pharmacological treatments and internet based self-guided psychological modules |  | 1: start of diagnostic testing; 2: after 3 month; 3: after 6 month; 4: after 9 month |