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

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.

Study Overview

• Status: Unknown
• Conditions: PTSD; Somatoform Disorders; Psychiatric Disorder
• Intervention / Treatment: Behavioral: psychotherapy

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Hannover, Lower Saxony, Germany, 30625
      • Recruiting
      • HannoverMS
      • Contact: Stefan M Henniger, MD; Phone Number: 6446 49 511 532; Email: Henniger.Stefan@MH-Hannover.de
      • Contact: Frieling, Prof.; Phone Number: 6840 49 511 532; Email: Frieling.Helge@mh-hannover.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: all patients in the department are primarily included. There are no parallel groups.

Collaborators and Investigators

• Sponsor: Hannover Medical School

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: July 8, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Estimate): July 12, 2011
• Last Update Submitted That Met QC Criteria: July 11, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: PTSD; psychotherapy; somatoform disorders; epigenetics; psychosomatics
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease; Problem Behavior; Mental Disorders; Somatoform Disorders
• Other Study ID Numbers: MHH-EK-5689