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

PTSD Clinical Trial

— TREPS  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01391897
• Other study ID #: MHH-EK-5689
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2011
• Last updated: July 11, 2011
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: June 2011
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: no national or international authority involved: GermanyLocal ethics-committee is supervising and has given approval: Germany
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Psychiatric Disorder
• PTSD
• Somatoform Disorders
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• psychotherapy
"multimodal complex psychotherapy"

Locations

Country	Name	City	State
Germany	HannoverMS	Hannover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany,