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

Sponsor

Hannover Medical School (Other)

Overall Status

Unknown status

CT.gov ID

NCT01391897

Collaborator

(none)

300

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychiatric Disorder Somatoform Disorders PTSD	Behavioral: psychotherapy

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2012

Anticipated Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.