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

NCT01391897 | Unknown

• 1 other identifier: MHH-EK-5689
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

1. 1.Epigenetic patterns found in the group of psychiatric patients show differences from healthy controls
2. 2.Different diagnosis show differences in epigenetic patterns as well
3. 3.Epigenetic patterns correlate to the severity of the psychosocial disorder as measured in interviews or psychometric ratings
4. 4.Epigenetic patterns can change under inpatient high dose psychotherapy
5. 5.Changes correlate to clinical psychometric variables.

Conditions

Psychiatric Disorder; Somatoform Disorders; PTSD

Keywords

somatoform disorders; PTSD; epigenetics; psychotherapy; psychosomatics

Study Arms (1)

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

Interventions

psychotherapy BEHAVIORAL

"multimodal complex psychotherapy"

Also known as: all patients in the department are primarily included. There are no parallel groups.

in- and out-patient psychotherapy patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

HannoverMS

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Mental Disorders; Somatoform Disorders; Stress Disorders, Post-Traumatic

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 12, 2011

Record last verified: 2011-06

Locations

DE (1)