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

Tracking Information
First Received Date ^ICMJE	July 8, 2011
Last Updated Date	July 11, 2011
Start Date ^ICMJE	January 2011
Estimated Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01391897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Epigenetics of Posttraumatic Stress Disorder and Somatoform Disorders in the Course of Psychotherapy
Official Title ^ICMJE	Not Provided
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 Epigenetic patterns found in the group of psychiatric patients show differences from healthy controls Different diagnosis show differences in epigenetic patterns as well Epigenetic patterns correlate to the severity of the psychosocial disorder as measured in interviews or psychometric ratings Epigenetic patterns can change under inpatient high dose psychotherapy Changes correlate to clinical psychometric variables.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: whole blood
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.
Condition ^ICMJE	Psychiatric Disorder Somatoform Disorders PTSD
Intervention ^ICMJE	Behavioral: psychotherapy "multimodal complex psychotherapy" Other Name: all patients in the department are primarily included. There are no parallel groups.
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	300
Estimated Completion Date	September 2012
Estimated Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01391897
Other Study ID Numbers ^ICMJE	MHH-EK-5689
Has Data Monitoring Committee	No
Responsible Party	Stefan Martin Henniger, MD., Department of Psychosomatic Medicin and Psychotherapy, Hannover Medical School, Hannover, Germany
Study Sponsor ^ICMJE	Hannover Medical School
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hannover Medical School
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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