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

This study is currently recruiting participants.
Verified June 2011 by Hannover Medical School
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01391897
First received: July 8, 2011
Last updated: July 11, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Psychiatric Disorder
Somatoform Disorders
PTSD
 Behavioral: psychotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 8, 2011
Last Updated: July 11, 2011
Health Authority: no national or international authority involved: Germany
Local ethics-committee is supervising and has given approval: Germany

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

Additional relevant MeSH terms:
Mental Disorders
Somatoform Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders

ClinicalTrials.gov processed this record on May 21, 2013