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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Narrative Exposure Therapy for Forensic Offender Rehab and Treatment as Usual
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:

  1. 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?
  2. 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?
  3. 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?
  4. 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?
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 groups in NCT02503488
Study groupRoleWhat they receive
Program GroupExperimentalThe 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 comparatorParticipants 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted21 Jul 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

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)
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

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.

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