Trauma TreatmentNCT01720732
Lifeline-NET (Narrative Exposure Therapy): A Short-term Treatment for Traumatized Refugees and Asylum Seekers
A study testing Lifeline NET in people with Trauma Treatment and Lifeline NET, run by University of Konstanz at 1 site in Germany.
Trial summary
Evaluation of a short version of Narrative Exposure Therapy Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Trauma Treatment, Lifeline NET, Modification of Narrative Exposure Therapy
- What is being tested?
- Lifeline NET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Dec 2014
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- PTSD
Who cannot join
- Psychotic Disorder,
- Severe Substance Dependence
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of a short version of Narrative Exposure Therapy
- Being tested
- Lifeline NET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifeline NETBehavioural
Also called LL-NET
Short Version of Narrative Exposure Therapy
| Study group | Role | What they receive |
|---|---|---|
| Lifeline NET | Experimental | Lifeline-NET (Short Version of NET) Receives: Behavioral: Lifeline NET |
| TAU | No intervention | Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD
Posttraumatic Stress Disorder Clinician Administered PTSD Scale
Measured: 9 months follow up
Secondary outcomes (1)
Other Symptoms following and related to Trauma, e.g. Depression, Dissociation
Other Symptoms following and related to Trauma, e.g. Depression, Dissociation
Measured: 9 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 posted2 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trauma TreatmentStudies 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
- 32 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
- NCT01720732
- Sponsor's protocol ID
- LL-NET2012
- Status last verified
- Dec 2014
- First submitted
- 7 Aug 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schauer M, Neuner F, Elbert T (2005/2011): Narrative Exposure Therapy. A Short-Term Intervention for Traumatic Stress Disorders. 2nd Ed. Cambridge/ Göttingen: Hogrefe & Huber Publishers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifeline-NET (Narrative Exposure Therapy): A Short-term Treatment for Traumatized Refugees and Asylum Seekers
- ClinicalTrials.gov ID
- NCT01720732
- Acronym / sponsor ID
- LL-NET2012
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Nov 2012 (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.
Evaluation of a short version of 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 |
|---|---|---|
| Lifeline NET | Experimental | Behavioral: Lifeline NETLifeline-NET (Short Version of NET) |
| TAU | No intervention | –Treatment as Usual |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- PTSD
Key exclusion criteria (2 listed)
- Psychotic Disorder,
- Severe Substance Dependence
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 |
|---|---|---|
| Lifeline NETAlso: LL-NETShort Version of Narrative Exposure Therapy | Behavioural | Lifeline NET |
Primary outcome
PTSD
Time frame: 9 months follow up
Posttraumatic Stress Disorder Clinician Administered PTSD Scale
1 secondary outcome
Other Symptoms following and related to Trauma, e.g. Depression, Dissociation
Time frame: 9 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 3 Dec 2014.
- BackgroundSchauer M, Neuner F, Elbert T (2005/2011): Narrative Exposure Therapy. A Short-Term Intervention for Traumatic Stress Disorders. 2nd Ed. Cambridge/ Göttingen: Hogrefe & Huber Publishers.
- NGOLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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 Lifeline NET in people with Trauma Treatment and Lifeline NET, 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 1 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 3 Dec 2014. 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 (time frame: 9 months follow up). 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 NCT01720732, which also lists 1 linked publication.
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 3 Dec 2014.