Psychiatric DisorderTREPSNCT01391897
Epigenetics of Posttraumatic Stress Disorder and Somatoform Disorders in the Course of Psychotherapy
An observational study of Psychiatric Disorder and Somatoform Disorders, run by Hannover Medical School at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychiatric Disorder, Somatoform Disorders, PTSD
- What is being tested?
- psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
HannoverMS
Hanover, Lower Saxony, 30625
Stefan M Henniger, MD, 49 511 532 ext. 6446, Henniger.Stefan@MH-Hannover.de
Frieling, Prof., 49 511 532 ext. 6840, Frieling.Helge@mh-hannover.de
About this study
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.
Read more
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.
- Conditions
- Psychiatric Disorder, Somatoform Disorders, PTSD
- Being tested
- psychotherapy
- Keywords
- somatoform disorders, PTSD, epigenetics, psychotherapy, psychosomatics
- Medical subject headings
- Mental Disorders, Somatoform Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychotherapyBehavioural
Also called all patients in the department are primarily included. There are no parallel groups.
"multimodal complex psychotherapy"
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: psychotherapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391897
- Sponsor's protocol ID
- MHH-EK-5689
- Acronym
- TREPS
- Status last verified
- Jun 2011
- First submitted
- 8 Jul 2011
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetics of Posttraumatic Stress Disorder and Somatoform Disorders in the Course of Psychotherapy
- ClinicalTrials.gov ID
- NCT01391897
- Acronym / sponsor ID
- TREPS / MHH-EK-5689
- Conditions
- Psychiatric Disorder, Somatoform Disorders, PTSD
- Keywords
- somatoform disorders, PTSD, epigenetics, psychotherapy, psychosomatics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| in- and out-patient psychotherapy patients | – | Behavioral: psychotherapyAll 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychotherapyAlso: all patients in the department are primarily included. There are no parallel groups."multimodal complex psychotherapy" | Behavioural | in- and out-patient psychotherapy patients |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder and Somatoform Disorders, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2011.