Posttraumatic Stress DisorderNCT02503488
Decreasing Youth Involvement in Violence in Burundi
A study testing Narrative Exposure Therapy for Forensic Offender Rehab and Treatment as Usual in people with Posttraumatic Stress Disorder and Depression, run by University of Konstanz at 1 site in Burundi.
Trial summary
The purpose of the current study is to examine the psychological well-being of youth within the context of participation in political violence during the 2015 election period in Burundi. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression, Aggression
- What is being tested?
- Narrative Exposure Therapy for Forensic Offender Rehab and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBurundi
- Study dates
- May 2015to Aug 2016
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- High degree of symptoms of posttraumatic stress disorder according to the Posttraumatic Symptom Scale
- High degree of appetitive aggression
- Violent behavior during the past three months
Who cannot join
- Current use of mind altering drugs
- Psychotic symptoms
Trial locations and contacts
1 site in 1 country.
Burundi1 site
vivo international & Psychologues sans Frontières mental health center
Bujumbura
About this study
The purpose of the current study is to examine the psychological well-being of youth within the context of participation in political violence during the 2015 election period in Burundi. In detail, the investigators are interested in fostering improved outcomes in a peace-building initiative aimed at youth in Burundi by reducing the mental health-related stress of the initiative's most severely affected participants. In addition, the investigators are interested in learning more about the youth experience of involvement in the Burundian political system in an effort to understand the links between youth engagement in political violence and past experiences of traumatic events.
Read the detailed description
The African Great Lakes Region is marked by several countries which have been ravaged by violence for several years. One of these countries is Burundi, a small state bordered by Rwanda, Tanzania and the Democratic Republic of the Congo. This country has been stricken by more than a decade of civil war, which ended only in 2006.
Today, many people still struggle in coping with the aftermath of the war. Political parties remain largely drawn along ethnic lines. These identities are often manipulated in order to incite violence and intimidation against opposing parties or groups. Violence between rival youth wings was a disturbing feature of the 2010 elections in Burundi, with similar conditions manifesting themselves in advance of the 2015 presidential election.
Further complicating the situation in Burundi, one of the problems people in war-affected populations often face is the high impairment due to mental health problems. Studies in crisis regions have shown that multiple experiences of traumatic life events seriously damages mental health and can lead to disorders such as Posttraumatic Stress Disorder (PTSD) or depression. Further, the risk of developing PTSD rapidly increases with the number of traumatic events experienced, as the occurrence of PTSD is more likely when the accumulation of trauma exceeds a certain limit. This phenomenon has been described as the "building block effect". This means, people in the context of armed conflicts and war are especially at risk to develop PTSD, as the total load of perceived stress is much higher than anywhere else. Furthermore, recent studies have revealed that combatants and other populations living in violent and insecure circumstances may adapt to their environment by developing an attraction to perpetrating violence, i.e. appetitive aggression. While appetitive aggression helps individuals to survive in violent environments by reducing their likelihood of developing trauma-related symptoms, it increases the risk of getting involved in the perpetration of violence.
In order to address the mental health needs of the participants in the present study, the investigators will be utilizing an intervention, Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET), that has been demonstrated to reduce posttraumatic symptomology and readiness for aggressive behavior.
Objectives:
The aim of the present study is to investigate the intersection of politics and mental health within the context of Burundi. Specifically, the study will be seeking to answer the following research questions:
- Mental Health Barriers to Participation in Peace Building Initiatives: What, if any, role does the presence of mental health issues such as PTSD and depression play in effective participation in peace-building efforts? Can FORNET contribute to peace building programs?
- Links Between Mental Health Issues and Political Participation: What is the role of mental health issues in shaping the readiness to resort to violence as a result of political beliefs and attitudes toward members of other political parties in a post-conflict setting?
- Appetitive Aggression. Does the concept of appetitive aggression influence the manner of political participation? Does appetitive aggression have a relationship to the perpetration of politically-motivated violence?
- Trauma-related disorders. Do trauma-related disorders such as PTSD and depression influence the manner of political participation? Do they have a relationship to the perpetration of politically-motivated violence?
- Conditions
- Posttraumatic Stress Disorder, Depression, Aggression
- Being tested
- Narrative Exposure Therapy for Forensic Offender Rehab, Treatment as Usual
- Keywords
- Appetitive Aggression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure Therapy for Forensic Offender RehabBehavioural
Also called FORNET
See arm description.
Treatment as UsualBehavioural
Also called TAU
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Program Group | Experimental | The treatment arm will consist of 20 randomly selected participants who will receive Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) for their traumatic symptomology, aggression, and depression. FORNET consists of a guided exposure of the participant's traumatic experiences in chronological order and integrating them into a coherent biographical memory.The intervention addresses the participant's positive, negative, and violent memories of events that have taken place during their lifetime, and also provides participants an opportunity to asses their current situation and future plans. FORNET can be completed in six sessions and each session lasts 90 minutes on average. Receives: Behavioral: Narrative Exposure Therapy for Forensic Offender Rehab |
| Treatment As Usual (TAU) | Active comparator | Participants in the TAU group will receive group and individual psycho-social support from trained peer-support workers, with 10 sessions occurring throughout the course of the intervention for each participant. In addition, there will be sensitisation trainings as well as mentoring for establishing greater financial independence. Last, TAU will include one-day events promoting social cohesion and peace. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline PTSD Scores at 3-months-followup and 9-months-followup
Will be assessed using the PSS-I
Measured: Baseline, 3 months, 9 months
Change in Baseline Depression Scores at 3-months-followup and 9-months-followup
Will be assessed using the Patient Health Questionnaire-9
Measured: Baseline, 3 months, 9 months
Change in Baseline Appetitive Aggression Scores at 3-months-followup and 9-months-followup
Assesses attitudes towards the perception and disposition of different forms of violence using the Appetitive Aggression Scale for Children (AAS-C).
Measured: Baseline, 3 months, 9 months
Secondary outcomes (3)
Change in Baseline Physical State at 3-months-followup and 9-months-followup
Will be assessed using a structured list of a range of ailments
Measured: Baseline, 3 months, 9 months
Change in Social Integration Scores at 3-months-followup and 9-months-followup
Will assess levels of participant integration with family and community using scores between 0-4, with higher scores indicating higher levels of social integration.
Measured: Baseline, 3 months, 9 months
Change in Scores on the Attitudes Toward Members of Other Political Parties Scale at 3-months-followup and 9-months-followup
Will assess nature of attitudes towards other political parties with which the participant is not affiliated.
Measured: Baseline, 3 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2016
- Study completionAug 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- Vivo international e.V., Action on Armed Violence, Psychologues sans Frontières Burundi
- Responsible party
- Principal investigator, Anselm Crombach, University of Konstanz
- Investigators
- Anselm Crombach, Principal investigator, University of Konstanz, vivo international e.V., Psychologues sans Frontiers Burundi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503488
- Sponsor's protocol ID
- UKonstanz
- Status last verified
- Nov 2017
- First submitted
- 30 Jun 2015
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Youth Involvement in Violence in Burundi
- ClinicalTrials.gov ID
- NCT02503488
- Acronym / sponsor ID
- UKonstanz
- Conditions
- Posttraumatic Stress Disorder, Depression, Aggression
- Keywords
- Appetitive Aggression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- Vivo international e.V., Action on Armed Violence, Psychologues sans Frontières Burundi
- Study start
- May 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Jul 2015 (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 the current study is to examine the psychological well-being of youth within the context of participation in political violence during the 2015 election period in Burundi. In detail, the investigators are interested in fostering improved outcomes in a peace-building initiative aimed at youth in Burundi by reducing the mental health-related stress of the initiative's most severely affected participants. In addition, the investigators are interested in learning more about the youth experience of involvement in the Burundian political system in an effort to understand the links between youth engagement in political violence and past experiences of traumatic events.
Detailed description
The African Great Lakes Region is marked by several countries which have been ravaged by violence for several years. One of these countries is Burundi, a small state bordered by Rwanda, Tanzania and the Democratic Republic of the Congo. This country has been stricken by more than a decade of civil war, which ended only in 2006.
Today, many people still struggle in coping with the aftermath of the war. Political parties remain largely drawn along ethnic lines. These identities are often manipulated in order to incite violence and intimidation against opposing parties or groups. Violence between rival youth wings was a disturbing feature of the 2010 elections in Burundi, with similar conditions manifesting themselves in advance of the 2015 presidential election.
Further complicating the situation in Burundi, one of the problems people in war-affected populations often face is the high impairment due to mental health problems. Studies in crisis regions have shown that multiple experiences of traumatic life events seriously damages mental health and can lead to disorders such as Posttraumatic Stress Disorder (PTSD) or depression. Further, the risk of developing PTSD rapidly increases with the number of traumatic events experienced, as the occurrence of PTSD is more likely when the accumulation of trauma exceeds a certain limit. This phenomenon has been described as the "building block effect". This means, people in the context of armed conflicts and war are especially at risk to develop PTSD, as the total load of perceived stress is much higher than anywhere else. Furthermore, recent studies have revealed that combatants and other populations living in violent and insecure circumstances may adapt to their environment by developing an attraction to perpetrating violence, i.e. appetitive aggression. While appetitive aggression helps individuals to survive in violent environments by reducing their likelihood of developing trauma-related symptoms, it increases the risk of getting involved in the perpetration of violence.
In order to address the mental health needs of the participants in the present study, the investigators will be utilizing an intervention, Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET), that has been demonstrated to reduce posttraumatic symptomology and readiness for aggressive behavior.
Objectives:
The aim of the present study is to investigate the intersection of politics and mental health within the context of Burundi. Specifically, the study will be seeking to answer the following research questions:
- Mental Health Barriers to Participation in Peace Building Initiatives: What, if any, role does the presence of mental health issues such as PTSD and depression play in effective participation in peace-building efforts? Can FORNET contribute to peace building programs?
- Links Between Mental Health Issues and Political Participation: What is the role of mental health issues in shaping the readiness to resort to violence as a result of political beliefs and attitudes toward members of other political parties in a post-conflict setting?
- Appetitive Aggression. Does the concept of appetitive aggression influence the manner of political participation? Does appetitive aggression have a relationship to the perpetration of politically-motivated violence?
- Trauma-related disorders. Do trauma-related disorders such as PTSD and depression influence the manner of political participation? Do they have a relationship to the perpetration of politically-motivated violence?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program Group | Experimental | Behavioral: Narrative Exposure Therapy for Forensic Offender RehabThe treatment arm will consist of 20 randomly selected participants who will receive Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) for their traumatic symptomology, aggression, and depression. FORNET consists of a guided exposure of the participant's traumatic experiences in chronological order and integrating them into a coherent biographical memory.The intervention addresses the participant's positive, negative, and violent memories of events that have taken place during their lifetime, and also provides participants an opportunity to asses their current situation and future plans. FORNET can be completed in six sessions and each session lasts 90 minutes on average. |
| Treatment As Usual (TAU) | Active comparator | Behavioral: Treatment as UsualParticipants in the TAU group will receive group and individual psycho-social support from trained peer-support workers, with 10 sessions occurring throughout the course of the intervention for each participant. In addition, there will be sensitisation trainings as well as mentoring for establishing greater financial independence. Last, TAU will include one-day events promoting social cohesion and peace. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- High degree of symptoms of posttraumatic stress disorder according to the Posttraumatic Symptom Scale
- High degree of appetitive aggression
- Violent behavior during the past three months
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 |
|---|---|---|
| Narrative Exposure Therapy for Forensic Offender RehabAlso: FORNETSee arm description. | Behavioural | Program Group |
| Treatment as UsualAlso: TAUSee arm description | Behavioural | Treatment As Usual (TAU) |
Primary outcome
Change in Baseline PTSD Scores at 3-months-followup and 9-months-followup
Time frame: Baseline, 3 months, 9 months
Will be assessed using the PSS-I
Change in Baseline Depression Scores at 3-months-followup and 9-months-followup
Time frame: Baseline, 3 months, 9 months
Will be assessed using the Patient Health Questionnaire-9
Change in Baseline Appetitive Aggression Scores at 3-months-followup and 9-months-followup
Time frame: Baseline, 3 months, 9 months
Assesses attitudes towards the perception and disposition of different forms of violence using the Appetitive Aggression Scale for Children (AAS-C).
3 secondary outcomes
Change in Baseline Physical State at 3-months-followup and 9-months-followup
Time frame: Baseline, 3 months, 9 months
Change in Social Integration Scores at 3-months-followup and 9-months-followup
Time frame: Baseline, 3 months, 9 months
Change in Scores on the Attitudes Toward Members of Other Political Parties Scale at 3-months-followup and 9-months-followup
Time frame: Baseline, 3 months, 9 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 29 Nov 2017.
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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.
Anselm Crombach principal investigator
University of Konstanz, vivo international e.V., Psychologues sans Frontiers Burundi
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 for Forensic Offender Rehab and Treatment as Usual in people with Posttraumatic Stress Disorder and Depression, 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 3 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 29 Nov 2017. 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.
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?
Change in Baseline PTSD Scores at 3-months-followup and 9-months-followup (time frame: Baseline, 3 months, 9 months). The study lists 3 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 29 Nov 2017.