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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02172066
Other study ID # UKCR2014
Secondary ID
Status Completed
Phase N/A
First received June 19, 2014
Last updated July 17, 2015
Start date June 2014
Est. completion date May 2015

Study information

Verified date July 2015
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority Burundi: Ethics Commission of the University Lumière de Bujumbura
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Narrative Exposure Therapy (NET)


Locations

Country Name City State
Burundi vivo international e.V.; University Lumière de Bujumbura; Red Cross Burundi Bujumbura

Sponsors (3)

Lead Sponsor Collaborator
University of Konstanz Université Lumière de Bujumbura, Vivo international e.V.

Country where clinical trial is conducted

Burundi, 

Outcome

Type Measure Description Time frame Safety issue
Other Previous traumatic events measured via vivo Event Checklist for War, Detention and Torture Experiences baseline No
Other Adverse experiences during childhood measured via the Domestic and Community Violence Checklist 3-months-follow-up No
Primary 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 baseline, 3-months-follow-up, 9-months-follow-up No
Secondary 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 baseline, 3-months-follow-up, 9-months-follow-up No
Secondary 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 baseline, 3-months-follow-up, 9-months-follow-up No
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