Post-traumatic Stress Disorder (PTSD)Phase 2NCT01729325
Prevention of Post-Traumatic Stress Disorder in Soldiers
A Phase 2 study testing Preventive Narrative Exposure Therapy in people with Post-traumatic Stress Disorder (PTSD) and Aggressive Behavior, run by University of Konstanz at 1 site in Burundi.
Trial summary
Soldiers in conflict or former conflict regions deployed in peace-keeping missions were and are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder (PTSD), Aggressive Behavior
- What is being tested?
- Preventive Narrative Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteBurundi
- Study dates
- Nov 2012to Apr 2015
- Phase
- Phase 2
- 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 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Exposure to traumatic experiences derived from expert interviews with scores of the Traumatic Life Event List for War and Torture
- Soldiers are part of the Burundian army and of the joint African Union and United Nations peacekeeping mission in Somalia (AMISOM)
Who cannot join
- Current use of mind altering drugs
- Psychotic symptoms
Trial locations and contacts
1 site in 1 country.
Burundi1 site
Burundian Army (FDN)
Bujumbura, Bujumbura Mairie Province
About this study
Official title: Prevention of Post-Traumatic Stress Disorder in Relation to Appetitive Aggression in Burundian Soldiers Deployed in a Peace-keeping Mission in Somalia
Soldiers in conflict or former conflict regions deployed in peace-keeping missions were and are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. The Preventive Narrative Exposure Therapy (Pre-NET) aims to reinforce resilience thereby reducing the risk of developing or aggravating PTSD or other mental disorders as a result of traumatic experiences. The effective prevention of mental disorders as a result of war deployment is expected to facilitate reintegration in civil life after deployment and reduce uncontrolled violence.
- Being tested
- Preventive Narrative Exposure Therapy
- Keywords
- Post-traumatic Stress disorder (PTSD), Aggressive Behavior, Appetitive Aggression, Resilience, Preventive Narrative Exposure Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive Narrative Exposure TherapyBehavioural
During Pre-NET the client, with the assistance of the therapist, constructs a chronological narrative of his whole life with a focus on exposure to traumatic stress. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior who asks in detail for emotions, cognitions, sensory information, and physiological reactions, linking them to an autobiographical context. During two sessions a chronological overview of the whole life with a focus on traumatic events is developed and the most important traumatic experiences are processed.
| Study group | Role | What they receive |
|---|---|---|
| Preventive Narrative Exposure Therapy | Experimental | Treatment with Pre-NET before deployment in peace-keeping mission Receives: Behavioral: Preventive Narrative Exposure Therapy |
| No treatment control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of traumatic symptoms measured via the Post-traumatic Stress Disorder Scale-Interview (PSS-I)
Measured: 15 months
Extend of appetitive aggression via the Appetitive Aggressions Scale (AAS)
Measured: 15 months
Secondary outcomes (3)
Severity of depressive symptoms measured via the Patient Health Questionnaire-9 (PHQ-9)
Measured: 15 months
Strength of suicidal ideation measured via the MINI
Measured: 15 months
Physical health complains
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2013
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- The Volkswagen Foundation
- Responsible party
- Principal investigator, Anselm Crombach, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729325
- Sponsor's protocol ID
- UKULBUSO2012
- Status last verified
- Jun 2015
- First submitted
- 13 Nov 2012
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-Traumatic Stress Disorder in Relation to Appetitive Aggression in Burundian Soldiers Deployed in a Peace-keeping Mission in Somalia
- ClinicalTrials.gov ID
- NCT01729325
- Acronym / sponsor ID
- UKULBUSO2012
- Keywords
- Post-traumatic Stress disorder (PTSD), Aggressive Behavior, Appetitive Aggression, Resilience, Preventive Narrative Exposure Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- The Volkswagen Foundation
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 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.
Soldiers in conflict or former conflict regions deployed in peace-keeping missions were and are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. The Preventive Narrative Exposure Therapy (Pre-NET) aims to reinforce resilience thereby reducing the risk of developing or aggravating PTSD or other mental disorders as a result of traumatic experiences. The effective prevention of mental disorders as a result of war deployment is expected to facilitate reintegration in civil life after deployment and reduce uncontrolled violence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preventive Narrative Exposure Therapy | Experimental | Behavioral: Preventive Narrative Exposure TherapyTreatment with Pre-NET before deployment in peace-keeping mission |
| No treatment control | No intervention | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Exposure to traumatic experiences derived from expert interviews with scores of the Traumatic Life Event List for War and Torture
- Soldiers are part of the Burundian army and of the joint African Union and United Nations peacekeeping mission in Somalia (AMISOM)
Key exclusion criteria (2 listed)
- Current use of mind altering drugs
- 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 |
|---|---|---|
| Preventive Narrative Exposure TherapyDuring Pre-NET the client, with the assistance of the therapist, constructs a chronological narrative of his whole life with a focus on exposure to traumatic stress. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior who asks in detail for emotions, cognitions, sensory information, and physiological reactions, linking them to an autobiographical context. During two sessions a chronological overview of the whole life with a focus on traumatic events is developed and the most important traumatic experiences are processed. | Behavioural | Preventive Narrative Exposure Therapy |
Primary outcome
Severity of traumatic symptoms measured via the Post-traumatic Stress Disorder Scale-Interview (PSS-I)
Time frame: 15 months
Extend of appetitive aggression via the Appetitive Aggressions Scale (AAS)
Time frame: 15 months
3 secondary outcomes
Severity of depressive symptoms measured via the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 15 months
Strength of suicidal ideation measured via the MINI
Time frame: 15 months
Physical health complains
Time frame: 15 months
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 4 Jun 2015.
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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 Phase 2 study testing Preventive Narrative Exposure Therapy in people with Post-traumatic Stress Disorder (PTSD) and Aggressive Behavior, run by University of Konstanz at 1 site in Burundi.
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 4 Jun 2015. 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 Burundi. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Severity of traumatic symptoms measured via the Post-traumatic Stress Disorder Scale-Interview (PSS-I) (time frame: 15 months). The study lists 2 primary outcomes in all. 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 4 Jun 2015.