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Epigenetics of Posttraumatic Stress Disorder and Somatoform Disorders in the Course of Psychotherapy (TREPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01391897
Recruitment Status : Unknown
Verified June 2011 by Hannover Medical School.
Recruitment status was:  Recruiting
First Posted : July 12, 2011
Last Update Posted : July 12, 2011
Information provided by:
Hannover Medical School

July 8, 2011
July 12, 2011
July 12, 2011
January 2011
January 2012   (Final data collection date for primary outcome measure)
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No Changes Posted
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Epigenetics of Posttraumatic Stress Disorder and Somatoform Disorders in the Course of Psychotherapy
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This reported observational clinical study aims at identifying epigenetic markers in a sample of patients undergoing high dose inpatient psychotherapy suffering from a variety of psychiatric/psychosomatic diseases such as somatoform disorders, posttraumatic stress disorder (PTSD), depression, anxiety disorders and eating disorders.

The exact epigenetic markers that will be traced are yet to define.

The investigators believe that

  1. Epigenetic patterns found in the group of psychiatric patients show differences from healthy controls
  2. Different diagnosis show differences in epigenetic patterns as well
  3. Epigenetic patterns correlate to the severity of the psychosocial disorder as measured in interviews or psychometric ratings
  4. Epigenetic patterns can change under inpatient high dose psychotherapy
  5. Changes correlate to clinical psychometric variables.
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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
whole blood
Non-Probability Sample

The present study includes all patients selected for multi-modal inpatient or day-clinic treatment in the department of psychosomatic medicine (as part of the centre of psychiatry)of the hannover medical school - given the informed consent of the patients. The patients treated in this unit are first seen in primary care and sent to us because of e.g. depression, somatization, eating-disorders, panic disorders, PTSD, or other psychiatric diseases commonly refered to as "psychosomatic" in Germany. They are subject to at least 2 diagnostic sessions in which further treamtment options are assessed.

For about one third of the patients with grave psychiatric disorders, intensive "multimodal" psychotherapy in an inpatient or day-clinic setting is recommended.

  • Psychiatric Disorder
  • Somatoform Disorders
  • PTSD
Behavioral: psychotherapy
"multimodal complex psychotherapy"
Other Name: all patients in the department are primarily included. There are no parallel groups.
in- and out-patient psychotherapy patients
All included patients are highly selected in- and outpatients in a department of psychosomatic medicine (Germany) undergoing high dose psychotherapy (e.g. group therapy, creative therapy, cbt and psychodynamic psychotherapy).
Intervention: Behavioral: psychotherapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
September 2012
January 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • informed consent given by the patient
  • adulthood to 65 years
  • stabel physical health
  • at least fluent in German language (as it is a group-therapy)

Exclusion Criteria:

  • psychiatric disorder such as substance addiction, psychosis, schizophrenia.
  • insufficient understanding of the terms and conditions of the study
  • insufficient emotional stability to fill out the psychometric forms required for the study.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Stefan Martin Henniger, MD., Department of Psychosomatic Medicin and Psychotherapy, Hannover Medical School, Hannover, Germany
Hannover Medical School
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Hannover Medical School
June 2011