Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-01-04 @ 2:17 PM
Study NCT ID:
NCT02992561
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000374', 'term': 'Aggression'}], 'ancestors': [{'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 402}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2016-12-06', 'studyFirstSubmitQcDate': '2016-12-10', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Social acknowledgement (0-45 indicating more social acknowledgment)', 'timeFrame': 'Change from baseline to 3-5 and 6-9 months post treatment', 'description': 'Social Acknowledgement Questionnaire (Maerker \\& Mueller, 2004)'}, {'measure': 'Depression (0-27 indicating higher severity)', 'timeFrame': 'Change from baseline to 3-5 and 6-9 months post treatment', 'description': 'Patient Health Questionnaire - 9 (Kroenke \\& Spitzer, 2002)'}, {'measure': 'Substance use problems', 'timeFrame': 'Change from baseline to 3-5 and 6-9 months post treatment', 'description': 'Alcohol, Smoking and Substance Involvement Screening Test (Humeniuk et al., 2008)'}, {'measure': 'Epigenetic changes', 'timeFrame': 'Change from baseline to 6-9 month post treatment', 'description': 'Genome wide methylation patterns (to be explored)'}], 'primaryOutcomes': [{'measure': 'Appetitive aggression (sumscore; 0-60 indicating higher levels)', 'timeFrame': 'Change from baseline to 3-5 and 6-9 months post treatment', 'description': 'Appetitive Aggression Scale (Weierstall \\& Ebert, 2011)'}, {'measure': 'Current violent behavior (sumscore; 0-96 indicating more acts)', 'timeFrame': 'Change from baseline to 3-5 and 6-9 months post treatment', 'description': 'A list of violent offenses perpetrated during the last 3 months (formerly used in Burundi; Crombach/Augsburger/Nandi)'}], 'secondaryOutcomes': [{'measure': 'PSS-I: Posttraumatic Stress Disorder (sumscore, 0-80 indicating higher severity)', 'timeFrame': 'Change from baseline to 3-5 and 6-9 months post treatment', 'description': 'PTSD Symptom Scale (Foa \\& Tolin, 2000)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aggression', 'Violence', 'Post-conflict reconstruction', 'Demobilization', 'Traumatized offenders'], 'conditions': ['Appetitive Aggression']}, 'referencesModule': {'references': [{'pmid': '34531495', 'type': 'DERIVED', '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.'}, {'pmid': '33829803', 'type': 'DERIVED', '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.'}, {'pmid': '31639529', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.brat.2019.103482', 'label': 'Results for the group of female former child soldiers'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility criteria\n\n* Former participant of an armed group in DR Congo\n* Involvement in violent attacks\n\nInclusion Criteria:\n\n* PTSD diagnosis or AAS sum score of 22 or higher\n\nExclusion Criteria:\n\n* Acute intoxification (alcohol or other drugs)\n* Acute psychotic symptoms\n* Sign of cerebro-organic diseases'}, 'identificationModule': {'nctId': 'NCT02992561', 'briefTitle': 'Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means', 'organization': {'class': 'OTHER', 'fullName': 'University of Konstanz'}, 'officialTitle': 'Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means: A Randomized Controlled Trial in Eastern DR Congo', 'orgStudyIdInfo': {'id': 'FORNET1617'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Narrative Exposure Therapy (FORNET, adapted version)', '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.', 'interventionNames': ['Behavioral: FORNET (adapted version)']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control or treatment as usual', 'description': 'No intervention or non-specific measures of support on request'}], 'interventions': [{'name': 'FORNET (adapted version)', 'type': 'BEHAVIORAL', 'otherNames': ['Narrative Exposure Therapy for Forensic Offender Rehabilitation (adapted version)'], 'armGroupLabels': ['Narrative Exposure Therapy (FORNET, adapted version)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78464', 'city': 'Konstanz', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University of Konstanz', 'geoPoint': {'lat': 47.66033, 'lon': 9.17582}}], 'overallOfficials': [{'name': 'Anke Köbach, PI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Konstanz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Konstanz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Researcher', 'investigatorFullName': 'Anke Köbach', 'investigatorAffiliation': 'University of Konstanz'}}}}