- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02172066
Narrative Exposure Therapy (NET) for Victims of the Recent Flood Disaster in Burundi
Evaluation of the Narrative Exposure Therapy (NET) as Means to Reduce Psychological Impairment in the Aftermath of the Recent Flood Disaster in Bujumbura, Burundi
In the aftermath of natural disasters, e.g., flood disasters, there is a great need for humanitarian assistance in the domain of psychological support. This is particularly true in post-conflict settings because people have suffered severely from multiple traumatic events and situations during their lives. The Narrative Exposure Therapy (NET) is a short-term, culturally sensitive treatment approach that aims to reduce Posttraumatic Stress Disorder (PTSD) symptoms.
The investigators want to provide evidence, that NET is an effective and efficient module to assist people in the aftermath of natural disasters using the example of the recent flood disaster in Burundi. In addition the investigators aim to explore, how traumatic incidences and maltreatment during childhood may influence treatment outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bujumbura, Burundi
- vivo international e.V.; University Lumière de Bujumbura; Red Cross Burundi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals severely affected (e.g., who had lost their children) by the flood disaster in Bujumbura
- All participants were part of the emergency program of the Red Cross Burundi who assisted those most affected by the flood disaster in Bujumbura
- Inclusion criteria for therapy: High degree of symptoms of posttraumatic stress disorder according to the Posttraumatic Symptom Scale - Interview (PSSI)
Exclusion Criteria:
- Pregnancy
- Current substance dependence
- Psychotic symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Narrative Exposure Therapy (NET)
During NET, the client, with the assistance of the therapist, constructs a chronological narrative of his or her entire life with a focus on exposure to traumatic stress.
Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior.
The therapist asks in detail for emotions, cognitions, sensory information, and physiological reactions to link the traumatic events to an autobiographical context, namely time and place.
In total the Individuals receive 6 sessions of NET, every session lasting between 1,5 and 2 hr depending on the needs of the participant.
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NO_INTERVENTION: No treatment control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Change from baseline in Diagnosis and load of PTSD symptoms assessed via the Posttraumatic Symptom Scale - Interview (PSS-I) at 3 and 9 months follow-up
Time Frame: baseline, 3-months-follow-up, 9-months-follow-up
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baseline, 3-months-follow-up, 9-months-follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Change from baseline in load of depressive symptoms assessed via the Patient Health Questionnaire-9 (PHQ-9) at 3 months and 9 months follow-up
Time Frame: baseline, 3-months-follow-up, 9-months-follow-up
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baseline, 3-months-follow-up, 9-months-follow-up
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Change in strength of suicidal ideation measured via the Mini International Neuropsychiatric Interview (M.I.N.I.) at 3 months and 6 months follow-up
Time Frame: baseline, 3-months-follow-up, 9-months-follow-up
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baseline, 3-months-follow-up, 9-months-follow-up
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Previous traumatic events measured via vivo Event Checklist for War, Detention and Torture Experiences
Time Frame: baseline
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baseline
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Adverse experiences during childhood measured via the Domestic and Community Violence Checklist
Time Frame: 3-months-follow-up
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3-months-follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anselm Crombach, Dr, University of Konstanz
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKCR2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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