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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02992561
Other study ID # FORNET1617
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date March 2019

Study information

Verified date July 2020
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Heightened levels of aggression are fuelling violent incidents at all levels, especially in post-war regions. Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) aims to address trauma symptoms along with reactive and instrumental/appetitive aggression to encounter the downward cycle of perpetration and enforce a sustainable (re-)integration into civil life. In the present study, the investigators provide an adapted version of FORNET to former combatants in the North Kivu, Eastern DR Congo. Structured baseline, 3 and 6 month follow up interviews will be administered to assess the main outcome measures recent violent acts and appetitive aggression.


Description:

Participants will be recruited through local NGOs and eligible clients randomized to the treatment or waitlist control group, respectively. The treatment will be provided by supervised local counsellors after a 4-week training. At baseline, 3-month and 6-month follow up, sociodemographic data, trauma exposure, perpetrated violent acts, PTSD, recent aggression, functionality and drug dependency will be assessed. The interviews will be conducted by blind Congolese psychological interviewers after an intensive 3-weeks training and continuous supervision.


Recruitment information / eligibility

Status Completed
Enrollment 402
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years to 80 Years
Eligibility Eligibility criteria

- Former participant of an armed group in DR Congo

- Involvement in violent attacks

Inclusion Criteria:

- PTSD diagnosis or AAS sum score of 22 or higher

Exclusion Criteria:

- Acute intoxification (alcohol or other drugs)

- Acute psychotic symptoms

- Sign of cerebro-organic diseases

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
FORNET (adapted version)


Locations

Country Name City State
Germany University of Konstanz Konstanz BW

Sponsors (1)

Lead Sponsor Collaborator
University of Konstanz

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Social acknowledgement (0-45 indicating more social acknowledgment) Social Acknowledgement Questionnaire (Maerker & Mueller, 2004) Change from baseline to 3-5 and 6-9 months post treatment
Other Depression (0-27 indicating higher severity) Patient Health Questionnaire - 9 (Kroenke & Spitzer, 2002) Change from baseline to 3-5 and 6-9 months post treatment
Other Substance use problems Alcohol, Smoking and Substance Involvement Screening Test (Humeniuk et al., 2008) Change from baseline to 3-5 and 6-9 months post treatment
Other Epigenetic changes Genome wide methylation patterns (to be explored) Change from baseline to 6-9 month post treatment
Primary Appetitive aggression (sumscore; 0-60 indicating higher levels) Appetitive Aggression Scale (Weierstall & Ebert, 2011) Change from baseline to 3-5 and 6-9 months post treatment
Primary Current violent behavior (sumscore; 0-96 indicating more acts) A list of violent offenses perpetrated during the last 3 months (formerly used in Burundi; Crombach/Augsburger/Nandi) Change from baseline to 3-5 and 6-9 months post treatment
Secondary PSS-I: Posttraumatic Stress Disorder (sumscore, 0-80 indicating higher severity) PTSD Symptom Scale (Foa & Tolin, 2000) Change from baseline to 3-5 and 6-9 months post treatment
See also
  Status Clinical Trial Phase
Completed NCT02242136 - Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants N/A
Completed NCT01625117 - Mental Health and Aggression in Congolese Ex-combatants Phase 2
Enrolling by invitation NCT01624987 - Intervention to Support the Reintegration of Former Combatants and Soldiers Phase 2/Phase 3