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Narrative Exposure Therapy (NET) for Victims of the Recent Flood Disaster in Burundi

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Burundi
Study Type
Interventional
Intervention
Narrative Exposure Therapy (NET)
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Childhood maltreatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • vivo international e.V.; University Lumière de Bujumbura; Red Cross Burundi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Narrative Exposure Therapy (NET)

No treatment control

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
June 19, 2014
Last Updated
July 17, 2015
Sponsor
University of Konstanz
Collaborators
Vivo international e.V., Université Lumière de Bujumbura
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1. Study Identification

Unique Protocol Identification Number
NCT02172066
Brief Title
Narrative Exposure Therapy (NET) for Victims of the Recent Flood Disaster in Burundi
Official Title
Evaluation of the Narrative Exposure Therapy (NET) as Means to Reduce Psychological Impairment in the Aftermath of the Recent Flood Disaster in Bujumbura, Burundi
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
Vivo international e.V., Université Lumière de Bujumbura

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic Stress Disorder, Childhood maltreatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrative Exposure Therapy (NET)
Arm Type
Experimental
Arm Description
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.
Arm Title
No treatment control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy (NET)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Other Pre-specified Outcome Measures:
Title
Previous traumatic events measured via vivo Event Checklist for War, Detention and Torture Experiences
Time Frame
baseline
Title
Adverse experiences during childhood measured via the Domestic and Community Violence Checklist
Time Frame
3-months-follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anselm Crombach, Dr
Organizational Affiliation
University of Konstanz
Official's Role
Principal Investigator
Facility Information:
Facility Name
vivo international e.V.; University Lumière de Bujumbura; Red Cross Burundi
City
Bujumbura
Country
Burundi

12. IPD Sharing Statement

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Narrative Exposure Therapy (NET) for Victims of the Recent Flood Disaster in Burundi

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