Treatment of Trauma and Violence in the Townships of South Africa

NCT02012738 | Completed DMC

• 1 other identifier: ERC-2012-AdG 323977 Memo TV
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Escalating violence is omnipresent in South African townships and can be traced back to two core mechanisms: a trauma-related hyper-arousal and a positive rewarding perception of violence. In the past, there was no therapeutic intervention available addressing both, trauma and the so-called appetitive aggression. The University of Konstanz has developed a culturally sensitive and scientifically based short-term intervention for the treatment of traumatized patients, the Narrative Exposure Therapy (NET), that has proven its effectiveness in various randomized clinical studies in different war-affected populations. Recently, the NET has been adapted for the forensic offender rehabilitation (FORNET) by also addressing the perpetration of violence related to a self-rewarding perception of the exposure with violence. It has shown to be effective in reducing the number of committed offenses in a perpetrator sample in Burundi and to reduce PTSD symptoms in a perpetrator sample in the Democratic Republic of the Congo. In this study, we investigated the therapeutic efficiency of FORNET in a randomized clinical control trial with a sample of former offenders of the townships of Cape Town. In addition to the previous studies, we specifically addressed the context of ongoing stress and linked our findings to epigenetic markers of stress and violence. Participants were followed over a period of up to 25-months post-treatment. The FORNET was also disseminated to local staff of our collaboration partners from the South African Universities and an organization working in the townships to warrant sustainability of the therapeutic intervention.

Conditions

Post-traumatic Stress Disorder (PTSD); Aggressive Behavior

Outcome Measures

Primary Outcomes (7)

• Change in PTSD symptom severity with the PSS-I the Post-traumatic Stress Disorder Scale- Interview (PSS-I) post-treatment at 6- and 12-month follow-up

  8, 18 and 25- month follow-up

• Change in Attraction to violence with the Appetitive Aggression Scale (AAS) post-treatment at 6- and 12-month follow-up

  8, 18 and 25- month follow-up

• Change in Methylation Pattern of the Glucocorticoid Receptor promoter region via saliva samples

  8, 18 and 25- month follow-up

• Change in Self-committed violence with the AAS offense list

  8, 18 and 25- month follow-up

• Influence of Social Acknowledgement with Social Acknowledgement Questionnaire (SAQ)

  8, 18 and 25- month follow-up

• Influence of drug abuse related to violence on number of offenses with the offense checklist (from the AAS)

  8, 18 and 25- month follow-up

• Change in Epigenetic Markers (methylation patterns) of violence in the androgen receptor promoter region via saliva samples

  8, 18 and 25- month follow-up

Secondary Outcomes (3)

• Change in Strength of suicidal ideation measured with the MINI 6.0.0.

  8, 18 and 25- month follow-up

• Change in Psychosocial Functioning measured with the WSAS (Work and Social Adjustment Scale)

  8, 18 and 25- month follow-up

• Change in Depression severity with the PHQ-9

  8, 18 and 25- month follow-up

Study Arms (4)

Assignment to FORNET

ACTIVE COMPARATOR

17 participants were randomly assigned to FORNET

Behavioral: FORNET

Assignment to CBT

ACTIVE COMPARATOR

14 participants were randomly assigned to CBT

Behavioral: CBT

Waiting List Control Group (camp)

OTHER

7 participants were randomly assigned to the Waiting List Control Group (camp)

Other: Waiting List Control Group (camp)

Waiting List Control Group (no camp)

OTHER

36 participants were assigned to the Waiting List Control Group (no camp)

Other: Waiting List Control Group (no camp)

Interventions

FORNET BEHAVIORAL

8 individual sessions: * 1 lifeline * 6 exposure sessions * 1 outlook

Assignment to FORNET

CBT BEHAVIORAL

7 individual sessions, according to the "Integrated cognitive behavior change program" manual, Bush et al., 1997, National Institute of Corrections, US Dept. of Justice.

Assignment to CBT

Waiting List Control Group (camp) OTHER

Participants, if still meeting the criteria and interested, will receive FORNET by local counsellors after the 8-months follow up.

Waiting List Control Group (camp)

Waiting List Control Group (no camp) OTHER

Participants, if still meeting the criteria and interested, will receive FORNET by local counsellors after the 8-months follow up.

Waiting List Control Group (no camp)

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• High levels of PTSD symptoms (i.e. Scores on the PSS-I \> 7 points)
• High levels of appetitive aggression (i.e. Scores on the Appetitive Aggression Scale (AAS) \> 8 points)
• participants are recruited through the community based re-integration program

You may not qualify if:

• acute psychotic episode

Sponsors & Collaborators

• University of Konstanz: lead
• University of Cape Town: collaborator
• University of Stellenbosch: collaborator

Study Sites (1)

Unknown Facility

Capetown, South Africa

Location

Related Publications (1)

• Hinsberger M, Holtzhausen L, Sommer J, Kaminer D, Elbert T, Seedat S, Wilker S, Crombach A, Weierstall R. Feasibility and effectiveness of narrative exposure therapy and cognitive behavioral therapy in a context of ongoing violence in South Africa. Psychol Trauma. 2017 May;9(3):282-291. doi: 10.1037/tra0000197. Epub 2016 Oct 6.

  PMID: 27710003 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Aggression

Interventions

Cyclic AMP

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides, Cyclic; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Thomas Elbert, Prof. Dr.

  University of Konstanz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor for Clinical Psychology and Behavioural Neuroscience

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: December 16, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

ZA (1)