Appetitive AggressionPhase 2NCT01625117
Mental Health and Aggression in Congolese Ex-combatants
A Phase 2 study testing A variant of Narrative Exposure Therapy in people with Appetitive Aggression and Posttraumatic Stress Disorder, run by University of Konstanz at 1 site in Republic of the Congo.
Trial summary
The purpose of this study is examine, whether a treatment approach, which is specifically tailored for perpetrators who have participated in violence (a variant of Narrative Exposure Therapy) is effective in the reduction of instrumental aggression and symptoms of posttraumatic stress disorder. Read more about this study
- Who is it for?
- Ages 16 to 35 years, men only
- Conditions the study is for
- Appetitive Aggression, Posttraumatic Stress Disorder
- What is being tested?
- A variant of Narrative Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteRepublic of the Congo
- Study dates
- May 2011to Sep 2012
- 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 16 to 35 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ex-combatants in Congo who live in a re-integration camp
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Republic of the Congo1 site
Reintegration camp for ex-combatants
Goma
About this study
The purpose of this study is examine, whether a treatment approach, which is specifically tailored for perpetrators who have participated in violence (a variant of Narrative Exposure Therapy) is effective in the reduction of instrumental aggression and symptoms of posttraumatic stress disorder.
Read the detailed description
The reintegration of former child soldiers and ex-combatants is a big challenge in war-torn countries. Former child soldiers and ex-combatants often suffer from mental health problems and show enhanced levels of aggression. The present study focuses on the reduction of appetitive aggression and the improvement of mental health in former child soldiers and ex-combatants in DR Congo.
- Being tested
- A variant of Narrative Exposure Therapy
- Keywords
- Treatment of ex-combatants, Narrative Exposure Therapy for ex-combatants, Appetitive Aggression, Posttraumatic Stress Disorder
- 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.
A variant of Narrative Exposure TherapyBehavioural
During the proposed therapy, the client constructs a chronological narrative of his or her whole life which includes all traumatic experiences and perpetrated violent acts. All emotions, cognitions, sensory information, and physiological reactions are activated and linked to the autobiographical context.In five sessions the therapist and the client try to go through all important traumatic experiences and perpetrated violent acts. The sixth session is a group session with four to five clients. The group session is oriented on Interpersonal Psychotherapy and focuses on the role change from soldier to civilian.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| A variant of Narrative exposure therapy | Experimental | Not described Receives: Behavioral: A variant of Narrative Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetitive aggression (Appetitive Aggression Scale)
Measured: 6 months
Symptoms of posttraumatic stress disorder (Posttraumatic Diagnostic Scale, PDS)
Measured: 6 months
Secondary outcomes (2)
Symptoms of depression (Mini-International Neuropsychiatric Interview)
Measured: 6 months
Functionality (Work and Social Adjustment Scale)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive AggressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Susanne Schaal, University of Konstanz
- Investigators
- Thomas Elbert, Prof. Dr., Study director, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625117
- Sponsor's protocol ID
- DFG_2011
- Status last verified
- Jun 2013
- First submitted
- 16 Jan 2012
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health and Aggression in Congolese Ex-combatants
- ClinicalTrials.gov ID
- NCT01625117
- Acronym / sponsor ID
- DFG_2011
- Keywords
- Treatment of ex-combatants, Narrative Exposure Therapy for ex-combatants, Appetitive Aggression, Posttraumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Jun 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.
The purpose of this study is examine, whether a treatment approach, which is specifically tailored for perpetrators who have participated in violence (a variant of Narrative Exposure Therapy) is effective in the reduction of instrumental aggression and symptoms of posttraumatic stress disorder.
Detailed description
The reintegration of former child soldiers and ex-combatants is a big challenge in war-torn countries. Former child soldiers and ex-combatants often suffer from mental health problems and show enhanced levels of aggression. The present study focuses on the reduction of appetitive aggression and the improvement of mental health in former child soldiers and ex-combatants in DR Congo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| A variant of Narrative exposure therapy | Experimental | Behavioral: A variant of Narrative Exposure Therapy |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Ex-combatants in Congo who live in a re-integration camp
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| A variant of Narrative Exposure TherapyDuring the proposed therapy, the client constructs a chronological narrative of his or her whole life which includes all traumatic experiences and perpetrated violent acts. All emotions, cognitions, sensory information, and physiological reactions are activated and linked to the autobiographical context.In five sessions the therapist and the client try to go through all important traumatic experiences and perpetrated violent acts. The sixth session is a group session with four to five clients. The group session is oriented on Interpersonal Psychotherapy and focuses on the role change from soldier to civilian. | Behavioural | A variant of Narrative exposure therapy |
Primary outcome
Appetitive aggression (Appetitive Aggression Scale)
Time frame: 6 months
Symptoms of posttraumatic stress disorder (Posttraumatic Diagnostic Scale, PDS)
Time frame: 6 months
2 secondary outcomes
Symptoms of depression (Mini-International Neuropsychiatric Interview)
Time frame: 6 months
Functionality (Work and Social Adjustment Scale)
Time frame: 6 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 26 Jun 2013.
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.
Thomas Elbert, Prof. Dr. study director
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 Phase 2 study testing A variant of Narrative Exposure Therapy in people with Appetitive Aggression and Posttraumatic Stress Disorder, run by University of Konstanz at 1 site in Republic of the Congo.
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 0 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 26 Jun 2013. 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 Republic of the Congo. 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?
Appetitive aggression (Appetitive Aggression Scale) (time frame: 6 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 26 Jun 2013.