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Completed

NCT Number: NCT02992561

Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means

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.

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Key information

Conditions

Appetitive Aggression Aberrant Motor Behavior in Dementia Aggression Behavior Behavioral Symptoms Social Behavior

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Konstanz

Konstanz, Baden-Wurttemberg, 78464, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FORNET (adapted version)

Behavioral

Other names: Narrative Exposure Therapy for Forensic Offender Rehabilitation (adapted version)

Primary outcomes

  1. Appetitive aggression (sumscore; 0-60 indicating higher levels)

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

    Appetitive Aggression Scale (Weierstall & Ebert, 2011)

  2. Current violent behavior (sumscore; 0-96 indicating more acts)

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

    A list of violent offenses perpetrated during the last 3 months (formerly used in Burundi; Crombach/Augsburger/Nandi)

Secondary outcomes

  1. 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)

Other outcomes

  1. Social acknowledgement (0-45 indicating more social acknowledgment)

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

    Social Acknowledgement Questionnaire (Maerker & Mueller, 2004)

  2. Depression (0-27 indicating higher severity)

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

    Patient Health Questionnaire - 9 (Kroenke & Spitzer, 2002)

  3. Substance use problems

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

    Alcohol, Smoking and Substance Involvement Screening Test (Humeniuk et al., 2008)

  4. Epigenetic changes

    Time frame: Change from baseline to 6-9 month post treatment

    Genome wide methylation patterns (to be explored)

Sponsors and collaborators

Lead sponsor

University of Konstanz

Other

Registry information

Official study title

Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means: A Randomized Controlled Trial in Eastern DR Congo

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2016
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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