PTSDNCT01206790
Immunological Changes Through Narrative Treatment of Post-Traumatic Stress Disorder (PTSD) in Torture Victims
A study testing NET in people with PTSD, run by University of Konstanz at 1 site in Germany.
Trial summary
Posttraumatic stress disorder (PTSD) is associated with poor health, high health care utilization, and an increased risk for a variety of somatic, inflammatory and autoimmune diseases. Research, including our own findings, indicates immunological alterations in PTSD patients. Read more about this study
- Who is it for?
- Ages 16 to 60 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
- 47 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Jan 2012
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- PTSD diagnosis
- experiences of organized violence/torture
Who cannot join
- psychotic disorder
- chronic inflammatory diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Konstanz, Department of Psychology
Konstanz, 78467
About this study
Official title: Immunological Changes Through Narrative Treatment of PTSD in Torture Victims
Posttraumatic stress disorder (PTSD) is associated with poor health, high health care utilization, and an increased risk for a variety of somatic, inflammatory and autoimmune diseases. Research, including our own findings, indicates immunological alterations in PTSD patients. The aim of this study is to investigate whether alterations in the immune system of PTSD patients are reversible through a trauma-specific short-term therapy (Narrative Exposure Therapy).
- Conditions
- PTSD
- Being tested
- NET
- Keywords
- PTSD, Narrative Exposure Therapy, torture victims, immune system
- 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 |
|---|---|---|
| Narrative Exposure Therapy (NET) | Experimental | Not described Receives: Behavioral: NET |
| Waitinglist Control Group | No intervention | Not described |
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 month after completion of treatment
Secondary outcomes (1)
changes in immunological parameters
Measured: 4 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 posted22 Sep 2010 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Iris-Tatjana Kolassa, University of Ulm
- Investigators
- Iris-Tatjana Kolassa, Prof. Dr., Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206790
- Sponsor's protocol ID
- NET-2010-KN
- Status last verified
- Feb 2012
- First submitted
- 21 Sep 2010
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Changes Through Narrative Treatment of PTSD in Torture Victims
- ClinicalTrials.gov ID
- NCT01206790
- Acronym / sponsor ID
- NET-2010-KN
- Conditions
- PTSD
- Keywords
- PTSD, Narrative Exposure Therapy, torture victims, immune system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Sep 2010 (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.
Posttraumatic stress disorder (PTSD) is associated with poor health, high health care utilization, and an increased risk for a variety of somatic, inflammatory and autoimmune diseases. Research, including our own findings, indicates immunological alterations in PTSD patients. The aim of this study is to investigate whether alterations in the immune system of PTSD patients are reversible through a trauma-specific short-term therapy (Narrative Exposure Therapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrative Exposure Therapy (NET) | Experimental | Behavioral: NET |
| Waitinglist Control Group | No intervention | – |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- PTSD diagnosis
- experiences of organized violence/torture
Key exclusion criteria (2 listed)
- psychotic disorder
- chronic inflammatory diseases
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 | Narrative Exposure Therapy (NET) |
Primary outcome
PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS)
Time frame: 4 month after completion of treatment
1 secondary outcome
changes in immunological parameters
Time frame: 4 months after completion of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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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.
Iris-Tatjana Kolassa, Prof. Dr. principal investigator
University of Ulm
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 2 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: finished, as of the sponsor's last update on 22 Feb 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 month after completion of treatment). It is what the study was designed to measure, not a finding.
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 22 Feb 2012.