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Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means

Primary Purpose

Appetitive Aggression

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

FORNET (adapted version)

About this trial

This is an interventional treatment trial for Appetitive Aggression focused on measuring Aggression, Violence, Post-conflict reconstruction, Demobilization, Traumatized offenders

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Konstanz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Narrative Exposure Therapy (FORNET, adapted version)

Waitlist control or treatment as usual

Arm Description

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.

No intervention or non-specific measures of support on request

Outcomes

Primary Outcome Measures

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

Appetitive Aggression Scale (Weierstall & Ebert, 2011)

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)

Secondary Outcome Measures

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

PTSD Symptom Scale (Foa & Tolin, 2000)

Full Information

NCT ID

NCT02992561

First Posted

December 6, 2016

Last Updated

July 31, 2020

Sponsor

University of Konstanz

1. Study Identification

Unique Protocol Identification Number

NCT02992561

Brief Title

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

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

September 2016 (Actual)

Primary Completion Date

March 2019 (Actual)

Study Completion Date

March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Konstanz

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Appetitive Aggression

Keywords

Aggression, Violence, Post-conflict reconstruction, Demobilization, Traumatized offenders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

402 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Narrative Exposure Therapy (FORNET, adapted version)

Arm Type

Active Comparator

Arm Description

Arm Title

Waitlist control or treatment as usual

Arm Type

No Intervention

Arm Description

No intervention or non-specific measures of support on request

Intervention Type

Behavioral

Intervention Name(s)

FORNET (adapted version)

Other Intervention Name(s)

Narrative Exposure Therapy for Forensic Offender Rehabilitation (adapted version)

Primary Outcome Measure Information:

Title

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

Description

Appetitive Aggression Scale (Weierstall & Ebert, 2011)

Time Frame

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

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

PTSD Symptom Scale (Foa & Tolin, 2000)

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Social acknowledgement (0-45 indicating more social acknowledgment)

Description

Social Acknowledgement Questionnaire (Maerker & Mueller, 2004)

Time Frame

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

Title

Depression (0-27 indicating higher severity)

Description

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

Time Frame

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

Title

Substance use problems

Description

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

Time Frame

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

Title

Epigenetic changes

Description

Genome wide methylation patterns (to be explored)

Time Frame

Change from baseline to 6-9 month post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anke Köbach, PI

Organizational Affiliation

University of Konstanz

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Konstanz

City

Konstanz

State/Province

ZIP/Postal Code

78464

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34531495

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.

Results Reference

derived

PubMed Identifier

33829803

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.

Results Reference

derived

PubMed Identifier

31639529

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.

Results Reference

derived

Links:

URL

https://doi.org/10.1016/j.brat.2019.103482

Description

Results for the group of female former child soldiers

Learn more about this trial

Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means

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