Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02503488
Other study ID # UKonstanz
Secondary ID
Status Completed
Phase N/A
First received June 30, 2015
Last updated November 27, 2017
Start date May 2015
Est. completion date August 2016

Study information

Verified date November 2017
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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?

1. 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?

2. 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?


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Current use of mind altering drugs

- Psychotic symptoms

Study Design


Intervention

Behavioral:
Narrative Exposure Therapy for Forensic Offender Rehab
See arm description.
Treatment as Usual
See arm description

Locations

Country Name City State
Burundi vivo international & Psychologues sans Frontières mental health center Bujumbura

Sponsors (4)

Lead Sponsor Collaborator
University of Konstanz Action on Armed Violence, Psychologues sans Frontières Burundi, Vivo international e.V.

Country where clinical trial is conducted

Burundi, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Scores on the Opinion on the Civil War Scale at 3-months-followup and 9-months-followup Will assess participant opinions on their acceptance of members of other ethnic groups, responsibility for the civil war, and reparation and transitions post-conflict. Baseline, 3 months, 9 months
Primary Change in Baseline PTSD Scores at 3-months-followup and 9-months-followup Will be assessed using the PSS-I Baseline, 3 months, 9 months
Primary Change in Baseline Depression Scores at 3-months-followup and 9-months-followup Will be assessed using the Patient Health Questionnaire-9 Baseline, 3 months, 9 months
Primary 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). Baseline, 3 months, 9 months
Secondary 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 Baseline, 3 months, 9 months
Secondary 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. Baseline, 3 months, 9 months
Secondary 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. Baseline, 3 months, 9 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A