Posttraumatic Stress DisorderNCT00717548
Efficacy of Narrative Exposure Therapy (NET) in Treating Women After Human Trafficking or Forced Prostitution
A study testing Narrative Exposure Therapy in people with Posttraumatic Stress Disorder and Depression, run by University of Konstanz at 1 site in Germany.
Trial summary
The purpose of this study is to perform an evaluation of a trauma-focused short-term intervention (Narrative Exposure Therapy; Schauer, M., Neuner, F. \& Elbert, T.) on a variety of clinical outcome measures (PTSD, Depression, Somatic Complaints, Dissociation) in women after sexual exploitation and women trafficking. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression, Dissociation
- What is being tested?
- Narrative Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Jul 2011
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sexual Exploitation or Women Trafficked or Forced Prostitution
- Symptoms of Post Traumatic Stress Disorder
Who cannot join
- Current Psychotic Symptoms
Trial locations and contacts
1 site in 1 country.
Germany1 site
Research and Psychological Outpatient Clinic, University of Konstanz, Center for Psychiatry, House 22
Konstanz, 78479
About this study
Official title: The Effectiveness of Narrative Exposure Therapy in Treating Women After Trafficking and Forced Prostitution
The purpose of this study is to perform an evaluation of a trauma-focused short-term intervention (Narrative Exposure Therapy; Schauer, M., Neuner, F. \& Elbert, T.) on a variety of clinical outcome measures (PTSD, Depression, Somatic Complaints, Dissociation) in women after sexual exploitation and women trafficking.
- Conditions
- Posttraumatic Stress Disorder, Depression, Dissociation
- Being tested
- Narrative Exposure Therapy
- Keywords
- Somatic Complaints
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Dissociative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure TherapyBehavioural
Trauma-Focused short term intervention (8-12 sessions)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Behavioral: Narrative Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD, Depression, Somatic Complaints, Dissociation
Measured: Pre-Test, 4-weeks-Post-Test, 6-months-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Ruf, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717548
- Sponsor's protocol ID
- FH05.06.2008
- Status last verified
- Nov 2012
- First submitted
- 15 Jul 2008
- Last updated
- 5 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Narrative Exposure Therapy in Treating Women After Trafficking and Forced Prostitution
- ClinicalTrials.gov ID
- NCT00717548
- Acronym / sponsor ID
- FH05.06.2008
- Conditions
- Posttraumatic Stress Disorder, Depression, Dissociation
- Keywords
- Somatic Complaints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Jul 2008 (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.
The purpose of this study is to perform an evaluation of a trauma-focused short-term intervention (Narrative Exposure Therapy; Schauer, M., Neuner, F. \& Elbert, T.) on a variety of clinical outcome measures (PTSD, Depression, Somatic Complaints, Dissociation) in women after sexual exploitation and women trafficking.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Narrative Exposure Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sexual Exploitation or Women Trafficked or Forced Prostitution
- Symptoms of Post Traumatic Stress Disorder
Key exclusion criteria (1 listed)
- Current Psychotic Symptoms
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 |
|---|---|---|
| Narrative Exposure TherapyTrauma-Focused short term intervention (8-12 sessions) | Behavioural | A |
Primary outcome
PTSD, Depression, Somatic Complaints, Dissociation
Time frame: Pre-Test, 4-weeks-Post-Test, 6-months-follow-up
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 5 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Exposure Therapy in people with Posttraumatic Stress Disorder and Depression, 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 1 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 5 Nov 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, Depression, Somatic Complaints, Dissociation (time frame: Pre-Test, 4-weeks-Post-Test, 6-months-follow-up). 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 5 Nov 2012.