- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02992561
Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means
July 31, 2020 updated by: Anke Köbach, University of Konstanz
Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means: A Randomized Controlled Trial in Eastern DR Congo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
402
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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BW
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Konstanz, BW, Germany, 78464
- University of Konstanz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Narrative Exposure Therapy (FORNET, adapted version)
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.
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Other Names:
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No Intervention: Waitlist control or treatment as usual
No intervention or non-specific measures of support on request
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appetitive aggression (sumscore; 0-60 indicating higher levels)
Time Frame: Change from baseline to 3-5 and 6-9 months post treatment
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Appetitive Aggression Scale (Weierstall & Ebert, 2011)
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Change from baseline to 3-5 and 6-9 months post treatment
|
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Current violent behavior (sumscore; 0-96 indicating more acts)
Time Frame: Change from baseline to 3-5 and 6-9 months post treatment
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A list of violent offenses perpetrated during the last 3 months (formerly used in Burundi; Crombach/Augsburger/Nandi)
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Change from baseline to 3-5 and 6-9 months post treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PSS-I: Posttraumatic Stress Disorder (sumscore, 0-80 indicating higher severity)
Time Frame: Change from baseline to 3-5 and 6-9 months post treatment
|
PTSD Symptom Scale (Foa & Tolin, 2000)
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Change from baseline to 3-5 and 6-9 months post treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social acknowledgement (0-45 indicating more social acknowledgment)
Time Frame: Change from baseline to 3-5 and 6-9 months post treatment
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Social Acknowledgement Questionnaire (Maerker & Mueller, 2004)
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Change from baseline to 3-5 and 6-9 months post treatment
|
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Depression (0-27 indicating higher severity)
Time Frame: Change from baseline to 3-5 and 6-9 months post treatment
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Patient Health Questionnaire - 9 (Kroenke & Spitzer, 2002)
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Change from baseline to 3-5 and 6-9 months post treatment
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Substance use problems
Time Frame: Change from baseline to 3-5 and 6-9 months post treatment
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Alcohol, Smoking and Substance Involvement Screening Test (Humeniuk et al., 2008)
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Change from baseline to 3-5 and 6-9 months post treatment
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Epigenetic changes
Time Frame: Change from baseline to 6-9 month post treatment
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Genome wide methylation patterns (to be explored)
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Change from baseline to 6-9 month post treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anke Köbach, PI, University of Konstanz
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
December 6, 2016
First Submitted That Met QC Criteria
December 10, 2016
First Posted (Estimate)
December 14, 2016
Study Record Updates
Last Update Posted (Actual)
August 4, 2020
Last Update Submitted That Met QC Criteria
July 31, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FORNET1617
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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