NCT02992561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

2.5 years

First QC Date

December 6, 2016

Last Update Submit

July 31, 2020

Conditions

Keywords

AggressionViolencePost-conflict reconstructionDemobilizationTraumatized offenders

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • PSS-I: Posttraumatic Stress Disorder (sumscore, 0-80 indicating higher severity)

    Change from baseline to 3-5 and 6-9 months post treatment

Other Outcomes (4)

  • Social acknowledgement (0-45 indicating more social acknowledgment)

    Change from baseline to 3-5 and 6-9 months post treatment

  • Depression (0-27 indicating higher severity)

    Change from baseline to 3-5 and 6-9 months post treatment

  • Substance use problems

    Change from baseline to 3-5 and 6-9 months post treatment

  • +1 more other outcomes

Study Arms (2)

Narrative Exposure Therapy (FORNET, adapted version)

ACTIVE COMPARATOR

Version of Narrative Exposure Therapy for Forensic Offender Rehabilitation including one lifeline session and 5 exposure sessions as well as 6 group sessions adapted from behavioral-therapy approaches for addiction problems.

Behavioral: FORNET (adapted version)

Waitlist control or treatment as usual

NO INTERVENTION

No intervention or non-specific measures of support on request

Interventions

Also known as: Narrative Exposure Therapy for Forensic Offender Rehabilitation (adapted version)
Narrative Exposure Therapy (FORNET, adapted version)

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • PTSD diagnosis or AAS sum score of 22 or higher

You may not qualify if:

  • Acute intoxification (alcohol or other drugs)
  • Acute psychotic symptoms
  • Sign of cerebro-organic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Konstanz

Konstanz, Baden-Wurttemberg, 78464, Germany

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Anke Köbach, PI

    University of Konstanz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Researcher

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 14, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

August 4, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations