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

NCT ID: NCT01391897

Last Updated: 2011-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Psychiatric Disorder Somatoform Disorders PTSD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

psychotherapy

Intervention Type BEHAVIORAL

"multimodal complex psychotherapy"

Interventions

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psychotherapy

"multimodal complex psychotherapy"

Intervention Type BEHAVIORAL

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Department of Psychosomatic Medicin and Psychotherapy, Hannover Medical School, Hannover, Germany

Locations

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HannoverMS

Hanover, Lower Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Stefan M Henniger, MD

Role: primary

49 511 532 ext. 6446

Frieling, Prof.

Role: backup

49 511 532 ext. 6840

Other Identifiers

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MHH-EK-5689

Identifier Type: -

Identifier Source: org_study_id

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