NCT02172066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 20, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

June 19, 2014

Last Update Submit

July 17, 2015

Conditions

Keywords

Posttraumatic Stress DisorderChildhood maltreatment

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

  • 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

Other Outcomes (2)

  • Previous traumatic events measured via vivo Event Checklist for War, Detention and Torture Experiences

    baseline

  • Adverse experiences during childhood measured via the Domestic and Community Violence Checklist

    3-months-follow-up

Study Arms (2)

Narrative Exposure Therapy (NET)

EXPERIMENTAL

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.

Behavioral: Narrative Exposure Therapy (NET)

No treatment control

NO INTERVENTION

Interventions

Narrative Exposure Therapy (NET)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Current substance dependence
  • Psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bujumbura, Burundi

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Anselm Crombach, Dr

    University of Konstanz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 19, 2014

First Posted

June 24, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 20, 2015

Record last verified: 2015-07

Locations