Posttraumatic Stress DisorderNCT02989987
NET for SGBV Survivors in Eastern DR Congo
A study testing Narrative Exposure Therapy and Social Support in people with Posttraumatic Stress Disorder and Shame, run by University of Konstanz at 1 site in Germany.
Trial summary
Throughout the last 10 years Narrative Exposure Therapy (NET) has evolved as one of the most effective, culturally sensitive trauma interventions. In the present study the effectiveness of NET delivered by trained health personnel in a sample of survivors of sexual and gender based violence (SGBV) who suffer from… Read more about this study
- Who is it for?
- Ages 16 to 80 years, women only
- Conditions the study is for
- Posttraumatic Stress Disorder, Shame
- What is being tested?
- Narrative Exposure Therapy and Social Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to 3 Apr 2019
- 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 16 to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- SGBV survivors (event happened more than 4 weeks ago)
- PTSD diagnosis (DSM-5)
Who cannot join
- Acute psychosis
- Signs of cerebro-organic disease
- Acute drug or alcohol intoxication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Narrative Exposure Therapy for Survivors of Sexual and Gender Based Violence in Eastern DR Congo
Throughout the last 10 years Narrative Exposure Therapy (NET) has evolved as one of the most effective, culturally sensitive trauma interventions. In the present study the effectiveness of NET delivered by trained health personnel in a sample of survivors of sexual and gender based violence (SGBV) who suffer from Posttraumatic Stress Disorder (PTSD) will be assessed. Structured baseline, 3 and 6 month follow up interviews will be administered to assess the main outcome measures PTSD and shame. The trial will take place in Goma, DR Congo, where SGBV and its sequelae has been a major problem.
Read the detailed description
Participants will be recruited through local NGOs and eligible clients randomized to the treatment (NET; app. N=100) or treatment-as-usual control (app. N=100) group, respectively. At baseline, 3-month and 6-month post-treatment, sociodemographic data, trauma exposure - esp. SGBV, PTSD, dissociation, shame, functionality and depression will be assessed in a structured interview. The interviews will be conducted by blind Congolese psychological interviewers after an intensive 3-weeks training and continuous supervision.
- Conditions
- Posttraumatic Stress Disorder, Shame
- Being tested
- Narrative Exposure Therapy, Social Support
- Keywords
- PTSD, Shame, Narrative Exposure Therapy, Sexual and gender based violence (SGBV), DR Congo
- Medical subject headings
- Stress Disorders, Post-Traumatic, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure TherapyBehavioural
Also called NET
Social SupportBehavioural
A local counselors provides social support on demand.
| Study group | Role | What they receive |
|---|---|---|
| Narrative Exposure Therapy | Active comparator | According to the NET manual (one lifeline session and 7 exposure sessions; see Schauer et al. 2011). Receives: Behavioral: Narrative Exposure Therapy |
| Treatment-as-usual | Active comparator | Social support (provided on demand) Receives: Behavioral: Social Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis)
PTSD Symptom Scale - Interview (PSS-I; Foa \& Tolin, 2000)
Measured: Change from baseline to 3 and 6 months post treatment
SVQ: Severity of shame (sumscore)
Shame Variability Questionnaire (Brown, Rizvi \& Linehan, unpublished)
Measured: Change from baseline to 3 and 6 months post treatment
Secondary outcomes (3)
ShutD: Severity of Shutdown Dissociation Symptoms (sumscore)
Shutdown Dissociation Scale (Schalinski et al., 2015)
Measured: Change from baseline to 3 and 6 months post treatment
PHQ: Depression symptom severity (sumscore)
Patient Health Questionnaire - 9 (PHQ-9; Kroenke \& Spitzer, 2002)
Measured: Change in 3 and 6 months post treatment
Functionality (sumscore)
Local Functionality Index (LFI; Bass et al., 2013)
Measured: 3 and 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startSep 2016
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- Vivo international e.V.
- Responsible party
- Principal investigator, Anke Köbach, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989987
- Sponsor's protocol ID
- SGBV1617
- Status last verified
- Sep 2019
- First submitted
- 6 Dec 2016
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Schauer, M., Schauer, M., Neuner, F., & Elbert, T. (2011). Narrative exposure therapy: A short-term treatment for traumatic stress disorders. Hogrefe Publishing.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrative Exposure Therapy for Survivors of Sexual and Gender Based Violence in Eastern DR Congo
- ClinicalTrials.gov ID
- NCT02989987
- Acronym / sponsor ID
- SGBV1617
- Conditions
- Posttraumatic Stress Disorder, Shame
- Keywords
- PTSD, Shame, Narrative Exposure Therapy, Sexual and gender based violence (SGBV), DR Congo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- Vivo international e.V.
- Study start
- Sep 2016 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Throughout the last 10 years Narrative Exposure Therapy (NET) has evolved as one of the most effective, culturally sensitive trauma interventions. In the present study the effectiveness of NET delivered by trained health personnel in a sample of survivors of sexual and gender based violence (SGBV) who suffer from Posttraumatic Stress Disorder (PTSD) will be assessed. Structured baseline, 3 and 6 month follow up interviews will be administered to assess the main outcome measures PTSD and shame. The trial will take place in Goma, DR Congo, where SGBV and its sequelae has been a major problem.
Detailed description
Participants will be recruited through local NGOs and eligible clients randomized to the treatment (NET; app. N=100) or treatment-as-usual control (app. N=100) group, respectively. At baseline, 3-month and 6-month post-treatment, sociodemographic data, trauma exposure - esp. SGBV, PTSD, dissociation, shame, functionality and depression will be assessed in a structured interview. The interviews will be conducted by blind Congolese psychological interviewers after an intensive 3-weeks training and continuous supervision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrative Exposure Therapy | Active comparator | Behavioral: Narrative Exposure TherapyAccording to the NET manual (one lifeline session and 7 exposure sessions; see Schauer et al. 2011). |
| Treatment-as-usual | Active comparator | Behavioral: Social SupportSocial support (provided on demand) |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- SGBV survivors (event happened more than 4 weeks ago)
- PTSD diagnosis (DSM-5)
Key exclusion criteria (3 listed)
- Acute psychosis
- Signs of cerebro-organic disease
- Acute drug or alcohol intoxication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative Exposure TherapyAlso: NET | Behavioural | Narrative Exposure Therapy |
| Social SupportA local counselors provides social support on demand. | Behavioural | Treatment-as-usual |
Primary outcome
PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis)
Time frame: Change from baseline to 3 and 6 months post treatment
PTSD Symptom Scale - Interview (PSS-I; Foa \& Tolin, 2000)
SVQ: Severity of shame (sumscore)
Time frame: Change from baseline to 3 and 6 months post treatment
Shame Variability Questionnaire (Brown, Rizvi \& Linehan, unpublished)
3 secondary outcomes
ShutD: Severity of Shutdown Dissociation Symptoms (sumscore)
Time frame: Change from baseline to 3 and 6 months post treatment
PHQ: Depression symptom severity (sumscore)
Time frame: Change in 3 and 6 months post treatment
Functionality (sumscore)
Time frame: 3 and 6 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- BackgroundSchauer, M., Schauer, M., Neuner, F., & Elbert, T. (2011). Narrative exposure therapy: A short-term treatment for traumatic stress disorders. Hogrefe Publishing.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Exposure Therapy and Social Support in people with Posttraumatic Stress Disorder and Shame, run by University of Konstanz at 1 site in Germany.
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 2 inclusion and 3 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 1 Oct 2019. 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 Germany. 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?
PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis) (time frame: Change from baseline to 3 and 6 months post treatment). The study lists 2 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 NCT02989987, 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 1 Oct 2019.