Appetitive AggressionPhase 2/3NCT01624987
Intervention to Support the Reintegration of Former Combatants and Soldiers
A Phase 2/3 study testing NET for Forensic Offender Rehabilitation (FORNET): a variant of Narrative Exposure Therapy in people with Appetitive Aggression and Post-traumatic Stress Disorder, run by University of Konstanz at 1 site in Republic of the Congo.
Trial summary
The project aims to investigate if trauma-related disorders and appetitive aggression can be reduced in former ex-combatants in DR Congo when a specific intervention (Narrative Exposure Therapy for Forensic Offender Rehabilitation, FORNET) is delivered by trained local personnel (phase 1). Read more about this study
- Who is it for?
- Ages 16 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Appetitive Aggression, Post-traumatic Stress Disorder
- What is being tested?
- NET for Forensic Offender Rehabilitation (FORNET): 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
- 100 participants
- Where
- 1 siteRepublic of the Congo
- Study dates
- Jun 2012to Feb 2014
- Phase
- Phase 2/3
- 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 70 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Ex-combatants who live in a transit camp in Goma, Congo.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Republic of the Congo1 site
Transit Camp for ex-combatants/Reintegration camp for ex-combatants (ETN)
Goma
About this study
The project aims to investigate if trauma-related disorders and appetitive aggression can be reduced in former ex-combatants in DR Congo when a specific intervention (Narrative Exposure Therapy for Forensic Offender Rehabilitation, FORNET) is delivered by trained local personnel (phase 1). In a second step, the project aims to investigates the treatment success if this specific therapy is carried out by local personnel who have been trained by other local personnel ("train the trainer", phase 2) under the supervision of experts of the University of Konstanz.
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.
The project consists of four steps:
- Training of selected DDRRR personnel(first generation)in FORNET (a variant of Narrative Exposure Therapy to treat trauma-related disorders and to reduce appetitive aggression)by experts from the University of Konstanz.
- Treatment phase 1: Intervention will be carried out by therapists of the first generation. The trained therapists of the first generation will be supervised from the experts of the University of Konstanz.
- Training of a second generation of DDRRR personnel in FORNET by the therapists of the first generation.
- Treatment phase 2: Intervention will be carried out by therapists of the second generation. The trained therapists of the second generation will be supervised from the therapists of the first generation.
The study is conceived as a randomized controlled study. In phase 1 and in phase 2, study participants will be randomized allocated to the intervention group (FORNET) and the control group (no intervention). The treatment effect will be measured by pre-post and 6-months follow-up evaluations.
- Being tested
- NET for Forensic Offender Rehabilitation (FORNET): a variant of Narrative Exposure Therapy, Control group
- Keywords
- Treatment of ex-combatants, FORNET for ex-combatants, Appetitive Aggression, Post-traumatic 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.
NET for Forensic Offender Rehabilitation (FORNET): 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 trained 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.
Control groupOther
The control group receives no intervention.
| Study group | Role | What they receive |
|---|---|---|
| NET for Forensic Offender Rehabilitation | Experimental | Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) Receives: Behavioral: NET for Forensic Offender Rehabilitation (FORNET): a variant of Narrative Exposure Therapy; Other: Control group |
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 post-traumatic stress disorder (Post-traumatic Diagnostic Scale, PDS)
Measured: 6 months
Secondary outcomes (4)
Symptoms of depression (Patient Health Questionnaire (PHQ-9)
Measured: 6 months
Functionality (Work and Social Adjustment Scale)
Measured: 6 months
Substance abuse
Measured: 6 months
Re-integration questionnaire
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 startJun 2012
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- World Bank
- 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
- NCT01624987
- Sponsor's protocol ID
- WB_2012
- Status last verified
- Jul 2013
- First submitted
- 19 Jun 2012
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Support the Reintegration of Former Combatants and Soldiers
- ClinicalTrials.gov ID
- NCT01624987
- Acronym / sponsor ID
- WB_2012
- Keywords
- Treatment of ex-combatants, FORNET for ex-combatants, Appetitive Aggression, Post-traumatic Stress Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- World Bank
- Study start
- Jun 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- 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 project aims to investigate if trauma-related disorders and appetitive aggression can be reduced in former ex-combatants in DR Congo when a specific intervention (Narrative Exposure Therapy for Forensic Offender Rehabilitation, FORNET) is delivered by trained local personnel (phase 1). In a second step, the project aims to investigates the treatment success if this specific therapy is carried out by local personnel who have been trained by other local personnel ("train the trainer", phase 2) under the supervision of experts of the University of Konstanz.
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.
The project consists of four steps:
- Training of selected DDRRR personnel(first generation)in FORNET (a variant of Narrative Exposure Therapy to treat trauma-related disorders and to reduce appetitive aggression)by experts from the University of Konstanz.
- Treatment phase 1: Intervention will be carried out by therapists of the first generation. The trained therapists of the first generation will be supervised from the experts of the University of Konstanz.
- Training of a second generation of DDRRR personnel in FORNET by the therapists of the first generation.
- Treatment phase 2: Intervention will be carried out by therapists of the second generation. The trained therapists of the second generation will be supervised from the therapists of the first generation.
The study is conceived as a randomized controlled study. In phase 1 and in phase 2, study participants will be randomized allocated to the intervention group (FORNET) and the control group (no intervention). The treatment effect will be measured by pre-post and 6-months follow-up evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NET for Forensic Offender Rehabilitation | Experimental | Behavioral: NET for Forensic Offender Rehabilitation (FORNET): a variant of Narrative Exposure Therapy, Other: Control groupNarrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Ex-combatants who live in a transit camp in Goma, Congo.
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 |
|---|---|---|
| NET for Forensic Offender Rehabilitation (FORNET): 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 trained 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 | NET for Forensic Offender Rehabilitation |
| Control groupThe control group receives no intervention. | Other | NET for Forensic Offender Rehabilitation |
Primary outcome
Appetitive Aggression (Appetitive Aggression Scale)
Time frame: 6 months
Symptoms of post-traumatic stress disorder (Post-traumatic Diagnostic Scale, PDS)
Time frame: 6 months
4 secondary outcomes
Symptoms of depression (Patient Health Questionnaire (PHQ-9)
Time frame: 6 months
Functionality (Work and Social Adjustment Scale)
Time frame: 6 months
Substance abuse
Time frame: 6 months
Re-integration questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 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 2/3 study testing NET for Forensic Offender Rehabilitation (FORNET): a variant of Narrative Exposure Therapy in people with Appetitive Aggression and Post-traumatic 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: status not confirmed, as of the sponsor's last update on 30 Jul 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 30 Jul 2013.