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Post-traumatic Stress Disorder (PTSD)NCT02012738

Treatment of Trauma and Violence in the Townships of South Africa

A study testing FORNET and CBT in people with Post-traumatic Stress Disorder (PTSD) and Aggressive Behavior, run by University of Konstanz at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 40 years, men only
What is being tested?
FORNET and CBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSouth Africa
Study dates
Oct 2013to Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 40 years
  • Men only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • acute psychotic episode

Trial locations and contacts

1 site in 1 country.

South Africa1 site
  • Study site

    Capetown

Other trials in South Africa

About this study

Official title: MemoTV: Epigenetic, Neural and Cognitive Memories of Traumatic Stress and Violence in Former Offenders of the Townships of South Africa

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.

Read the detailed description

A group of 290 former young male offenders and young males at risk for perpetrating or becoming victims of crime (age 10-40) from Cape Town, recruited via a community based skill-training program has been interviewed in a first step. Participants with neurological or psychiatric disorders other than those resulting from exposure to traumatic stress, like chronic psychosis, were excluded from participation in the study but received referrals in the professional health care system, if necessary.

We applied standardised clinical questionnaires in a semi-structured interview for the assessment of exposure to traumatic stress (Children Exposed to Community Violence (CEVC)), trauma symptomatology (PSS-I for diagnosis of post-traumatic stress disorder), aggression (Appetitive Aggression Scale (AAS); Buss \& Perry Aggression Questionnaire), offense types checklist (from the AAS) and related drug abuse, psychosocial functioning (Work and Social Adjustment Scale, WSAS) and suicidality (M.I.N.I. 6.0.0., shortened version). Additionally, we used a questionnaire about social acknowledgement (Social Acknowledgement Questionnaire) and substance dependence (M.I.N.I. version 6.0.0).

We set up a randomised clinical intervention trial for the treatment of former offenders that covers violence perpetration on the one hand and traumatization on the other. 90 participants were chosen by the highest aggression scale scores and a certain threshold of trauma symptoms. 17 participants received FORNET, while 14 matched participants received CBT and another 7 matched participants treatment as usual (Waiting List camp) in a camp. Matching took place according to the severity of trauma symptomatology, aggressive behavior and suicidality. 36 participants didn't receive intervention and weren't part of the camp (Waiting List no camp) but were included in the follow-ups. In order to compare the treatment effect with the two control groups and follow the long-term effects, post-treatment assessments with the initial survey were performed about 8, 18 and 25 months post-treatment.

After the follow-ups, 17 FORNET participants and 11 CBT participants were included in the analysis. Two CBT clients had been excluded since they had not come to the follow-ups, one CBT client died a relatively sudden death due to a severe disease. The camp waiting list had been reduced to only six persons since one participant of the waiting list has been stabbed to death in a gang fight. Therefore a combined waiting list has been emerged from the two waiting lists ("camp" and "no camp"). 13 men from the "no camp"-waiting list were excluded since they have not been to the follow ups. From the residual 21 clients from this waiting list, 11 have been matched (together with the six participants from the "camp"-waiting list) with the participants from the FORNET and CBT group in terms of post traumatic stress symptom severity, level of appetitive aggression and suicidality. In the end 17 FORNET-, 11CBT- and 17 waiting list-attendees have been included into the analysis, hence a total sample size of 45 participants.

The 2 subjects of the control group, that still fulfilled the criteria for the therapy study and were interested in it, received FORNET by trained ZA staff for ethical reasons and to examine whether it is possible to effectively disseminate FORNET.

In addition to the subjective data, we will corroborate the results with the assessment of epigenetic consequences of appetitive aggression and trauma and investigate its significance and persistence in the long-term course of the study. We propose that specific DNA methylation patterns are important markers of environmentally driven mental health pathologies, such as chronic aggression/violence and traumatic stress in such a sample of perpetrators or young males at risk for perpetration. Further, we will test the stability of DNA methylation and its potential modification over a period of up to 25 months by behavioural intervention (FORNET).

Saliva samples (2ml) were collected through a non-invasive method using Oragene-Discover (OGR- 500) Collection Kit (DNA genotek, Ontario, Canada). We will collect two DNA saliva samples and one RNA saliva sample. Methylation patterns will be assessed at the University of Stellenbosch (Prof. Soraya Seedat), focussing on markers of trauma and violence.

Being tested
FORNET, CBT, Waiting List Control Group (camp), Waiting List Control Group (no camp)
Medical subject headings
Stress Disorders, Post-Traumatic, Aggression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FORNETBehavioural

    8 individual sessions:

    • 1 lifeline
    • 6 exposure sessions
    • 1 outlook
  • CBTBehavioural

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

  • 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 (no camp)Other

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

Study groups in NCT02012738
Study groupRoleWhat they receive
Assignment to FORNETActive comparator17 participants were randomly assigned to FORNET
Receives: Behavioral: FORNET
Assignment to CBTActive comparator14 participants were randomly assigned to CBT
Receives: Behavioral: CBT
Waiting List Control Group (camp)Other7 participants were randomly assigned to the Waiting List Control Group (camp)
Receives: Other: Waiting List Control Group (camp)
Waiting List Control Group (no camp)Other36 participants were assigned to the Waiting List Control Group (no camp)
Receives: Other: Waiting List Control Group (no camp)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 8, 18 and 25- month follow-up

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

    Measured: 8, 18 and 25- month follow-up

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

    Measured: 8, 18 and 25- month follow-up

  4. Change in Self-committed violence with the AAS offense list

    Measured: 8, 18 and 25- month follow-up

  5. Influence of Social Acknowledgement with Social Acknowledgement Questionnaire (SAQ)

    Measured: 8, 18 and 25- month follow-up

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

    Measured: 8, 18 and 25- month follow-up

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

    Measured: 8, 18 and 25- month follow-up

Secondary outcomes (3)
  1. Change in Strength of suicidal ideation measured with the MINI 6.0.0.

    Measured: 8, 18 and 25- month follow-up

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

    Measured: 8, 18 and 25- month follow-up

  3. Change in Depression severity with the PHQ-9

    Measured: 8, 18 and 25- month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02012738
Sponsor's protocol ID
ERC-2012-AdG 323977 Memo TV
Status last verified
May 2016
First submitted
9 Oct 2013
Last updated
13 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27710003

Questions about this trial

What is this clinical trial studying?

A study testing FORNET and CBT in people with Post-traumatic Stress Disorder (PTSD) and Aggressive Behavior, run by University of Konstanz at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 8, 18 and 25- month follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02012738, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.

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