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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Hannover Medical School.
Recruitment status was  Recruiting
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

July 8, 2011
July 11, 2011
January 2011
January 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01391897 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Epigenetics of Posttraumatic Stress Disorder and Somatoform Disorders in the Course of Psychotherapy
Not Provided

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
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.
Both
18 Years to 65 Years
No
Not Provided
Germany
 
NCT01391897
MHH-EK-5689
No
Stefan Martin Henniger, MD., Department of Psychosomatic Medicin and Psychotherapy, Hannover Medical School, Hannover, Germany
Hannover Medical School
Not Provided
Not Provided
Hannover Medical School
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP