- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00563888
Change of Neural Network Indicators Through Narrative Treatment of PTSD in Torture Victims
November 23, 2007 updated by: University of Konstanz
Effective Treatment of PTSD involves talking about the traumatic event in detail.It is unclear how this process influences the sensory-specific trauma network (fear structure)in the traumatized person.
The goal of the project is to test the hypothesis that treatment-facilitated recovery does not change the original fear structure but establishes an inhibitory mechanism that depends on verbal activity.
An affective visual steady-state paradigm in magnetencephalography (MEG) using positive, aversive and neutral picture stimuli will be used to examine the spatial and temporal pattern of the processing of emotional stimuli.
To examine the effects of treatment this paradigm will be used as outcome measure within a randomized controlled trial of Narrative Exposure Therapy and a waiting-list control condition for severely traumatized torture victims.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Konstanz, Germany, 78467
- University of Konstanz, Department of Psychology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- experiences of organized violence/torture
- PTSD diagnosis
Exclusion Criteria:
- psychotic disorder
- neurological disease or seizures
- current drug/alcohol abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Narrative Exposure Therapy (NET)
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Narrative Exposure Therapy for traumatized survivors of organized violence
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No Intervention: B
Waitinglist Control Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS)
Time Frame: 4 & 9 months after completion of treatment
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4 & 9 months after completion of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
steady state visual evoked magnetic fields in response to affective stimuli
Time Frame: 4 & 9 months after completion of treatment
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4 & 9 months after completion of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Claudia Catani, Dr., University of Konstanz
- Principal Investigator: Frank Neuner, Prof., University of Konstanz
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Adenauer H, Catani C, Gola H, Keil J, Ruf M, Schauer M, Neuner F. Narrative exposure therapy for PTSD increases top-down processing of aversive stimuli--evidence from a randomized controlled treatment trial. BMC Neurosci. 2011 Dec 19;12:127. doi: 10.1186/1471-2202-12-127.
- Adenauer H, Pinosch S, Catani C, Gola H, Keil J, Kissler J, Neuner F. Early processing of threat cues in posttraumatic stress disorder-evidence for a cortical vigilance-avoidance reaction. Biol Psychiatry. 2010 Sep 1;68(5):451-8. doi: 10.1016/j.biopsych.2010.05.015.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Completion (Anticipated)
December 1, 2008
Study Registration Dates
First Submitted
November 23, 2007
First Submitted That Met QC Criteria
November 23, 2007
First Posted (Estimate)
November 26, 2007
Study Record Updates
Last Update Posted (Estimate)
November 26, 2007
Last Update Submitted That Met QC Criteria
November 23, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOSS-B6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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