Clinical trial NCT02992561: Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means
Official title: Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means: A Randomized Controlled Trial in Eastern DR Congo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Aggression
Keywords: Aggression
Violence
Post-conflict reconstruction
Demobilization
Traumatized offenders
Lead sponsor: University of Konstanz
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 402
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Appetitive aggression (sumscore; 0-60 indicating higher levels)
timeFrame: Change from baseline to 3-5 and 6-9 months post treatment
measure: Current violent behavior (sumscore; 0-96 indicating more acts)
timeFrame: Change from baseline to 3-5 and 6-9 months post treatment
Secondary outcomes:
measure: PSS-I: Posttraumatic Stress Disorder (sumscore, 0-80 indicating higher severity)
timeFrame: Change from baseline to 3-5 and 6-9 months post treatment
Other outcomes:
measure: Social acknowledgement (0-45 indicating more social acknowledgment)
timeFrame: Change from baseline to 3-5 and 6-9 months post treatment
measure: Depression (0-27 indicating higher severity)
timeFrame: Change from baseline to 3-5 and 6-9 months post treatment
measure: Substance use problems
timeFrame: Change from baseline to 3-5 and 6-9 months post treatment
measure: Epigenetic changes
timeFrame: Change from baseline to 6-9 month post treatment
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz
state: BW
Study officials:
affiliation: University of Konstanz
name: Anke Köbach, PI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carleial S, Natt D, Unternahrer E, Elbert T, Robjant K, Wilker S, Vukojevic V, Kolassa IT, Zeller AC, Koebach A. DNA methylation changes following narrative exposure therapy in a randomized controlled trial with female former child soldiers. Sci Rep. 2021 Sep 16;11(1):18493. doi: 10.1038/s41598-021-98067-9.
citation: Koebach A, Carleial S, Elbert T, Schmitt S, Robjant K. Treating trauma and aggression with narrative exposure therapy in former child and adult soldiers: A randomized controlled trial in Eastern DR Congo. J Consult Clin Psychol. 2021 Mar;89(3):143-155. doi: 10.1037/ccp0000632.
citation: Robjant K, Koebach A, Schmitt S, Chibashimba A, Carleial S, Elbert T. The treatment of posttraumatic stress symptoms and aggression in female former child soldiers using adapted Narrative Exposure therapy - a RCT in Eastern Democratic Republic of Congo. Behav Res Ther. 2019 Dec;123:103482. doi: 10.1016/j.brat.2019.103482. Epub 2019 Sep 27.