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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
402

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
    • BW
      • Konstanz, BW, Germany, 78464
        • University of Konstanz

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: FORNET (adapted version)
Other Names:
  • Narrative Exposure Therapy for Forensic Offender Rehabilitation (adapted version)
No Intervention: Waitlist control or treatment as usual
No intervention or non-specific measures of support on request

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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)
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)
Change from baseline to 3-5 and 6-9 months post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
Change from baseline to 3-5 and 6-9 months post treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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
Social Acknowledgement Questionnaire (Maerker & Mueller, 2004)
Change from baseline to 3-5 and 6-9 months post treatment
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)
Change from baseline to 3-5 and 6-9 months post treatment
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)
Change from baseline to 3-5 and 6-9 months post treatment
Epigenetic changes
Time Frame: Change from baseline to 6-9 month post treatment
Genome wide methylation patterns (to be explored)
Change from baseline to 6-9 month post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Konstanz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings