PTSDNCT00563888
Change of Neural Network Indicators Through Narrative Treatment of PTSD in Torture Victims
A study testing NET in people with PTSD, run by University of Konstanz at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD
- What is being tested?
- NET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Dec 2008
- Phase
- Interventional
- 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
Who may be able to join
- experiences of organized violence/torture
- PTSD diagnosis
Who cannot join
- psychotic disorder
- neurological disease or seizures
- current drug/alcohol abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Konstanz, Department of Psychology
Konstanz, 78467
About this study
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.
- Conditions
- PTSD
- Being tested
- NET
- Keywords
- PTSD, torture survivors, Narrative Exposure Therapy, trauma-related memory processes, steady state visual evoked fields
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NETBehavioural
Narrative Exposure Therapy for traumatized survivors of organized violence
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Narrative Exposure Therapy (NET) Receives: Behavioral: NET |
| B | No intervention | Waitinglist Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS)
Measured: 4 & 9 months after completion of treatment
Secondary outcomes (1)
steady state visual evoked magnetic fields in response to affective stimuli
Measured: 4 & 9 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startJan 2007
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Investigators
- Claudia Catani, Dr., Study director, University of KonstanzFrank Neuner, Prof., Principal investigator, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563888
- Sponsor's protocol ID
- SOSS-B6
- Other IDs
- SOSS-B6
- Status last verified
- Nov 2007
- First submitted
- 23 Nov 2007
- Last updated
- 26 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22182346Adenauer 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.
PubMed 20619396
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Neural Network Indicators Through Narrative Treatment of PTSD in Torture Victims
- ClinicalTrials.gov ID
- NCT00563888
- Acronym / sponsor ID
- SOSS-B6
- Conditions
- PTSD
- Keywords
- PTSD, torture survivors, Narrative Exposure Therapy, trauma-related memory processes, steady state visual evoked fields
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jan 2007
- Study completion
- Dec 2008 (estimated)
- First posted
- 26 Nov 2007 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: NETNarrative Exposure Therapy (NET) |
| B | No intervention | –Waitinglist Control Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- experiences of organized violence/torture
- PTSD diagnosis
Key exclusion criteria (3 listed)
- psychotic disorder
- neurological disease or seizures
- current drug/alcohol abuse
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 |
|---|---|---|
| NETNarrative Exposure Therapy for traumatized survivors of organized violence | Behavioural | A |
Primary outcome
PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS)
Time frame: 4 & 9 months after completion of treatment
1 secondary outcome
steady state visual evoked magnetic fields in response to affective stimuli
Time frame: 4 & 9 months after completion of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2007.
- Derived from this study: PubMed 22182346Adenauer 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.
- Derived from this study: PubMed 20619396Adenauer 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.
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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.
Claudia Catani, Dr. study director
University of Konstanz
Frank Neuner, Prof. principal investigator
University of Konstanz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NET in people with PTSD, run by University of Konstanz 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 2 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 26 Nov 2007. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) (time frame: 4 & 9 months after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00563888, which also lists 2 linked publications.
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 26 Nov 2007.