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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Psychiatric Disorder Somatoform Disorders PTSD Behavioral: psychotherapy

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : September 2012
Groups and Cohorts

Group/Cohort Intervention/treatment
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).
Behavioral: psychotherapy
"multimodal complex psychotherapy"
Other Name: all patients in the department are primarily included. There are no parallel groups.


Outcome Measures

Biospecimen Retention:   Samples With DNA
whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391897


Locations
Germany
HannoverMS Recruiting
Hannover, Lower Saxony, Germany, 30625
Contact: Stefan M Henniger, MD    49 511 532 ext 6446    Henniger.Stefan@MH-Hannover.de   
Contact: Frieling, Prof.    49 511 532 ext 6840    Frieling.Helge@mh-hannover.de   
Sponsors and Collaborators
Hannover Medical School
More Information

Responsible Party: Stefan Martin Henniger, MD., Department of Psychosomatic Medicin and Psychotherapy, Hannover Medical School, Hannover, Germany
ClinicalTrials.gov Identifier: NCT01391897     History of Changes
Other Study ID Numbers: MHH-EK-5689
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: June 2011

Keywords provided by Hannover Medical School:
somatoform disorders
PTSD
epigenetics
psychotherapy
psychosomatics

Additional relevant MeSH terms:
Disease
Mental Disorders
Problem Behavior
Somatoform Disorders
Pathologic Processes
Behavioral Symptoms