Posttraumatic Stress DisorderNCT02172066
Narrative Exposure Therapy (NET) for Victims of the Recent Flood Disaster in Burundi
A study testing Narrative Exposure Therapy (NET) in people with Posttraumatic Stress Disorder, run by University of Konstanz at 1 site in Burundi.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Narrative Exposure Therapy (NET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBurundi
- Study dates
- Jun 2014to May 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Pregnancy
- Current substance dependence
- Psychotic symptoms
Trial locations and contacts
1 site in 1 country.
Burundi1 site
vivo international e.V.; University Lumière de Bujumbura; Red Cross Burundi
Bujumbura
About this study
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
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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Narrative Exposure Therapy (NET)
- Keywords
- Posttraumatic Stress Disorder, Childhood maltreatment
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure Therapy (NET)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Narrative Exposure Therapy (NET) |
| No treatment control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: baseline, 3-months-follow-up, 9-months-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- Vivo international e.V., Université Lumière de Bujumbura
- Responsible party
- Principal investigator, Anselm Crombach, University of Konstanz
- Investigators
- Anselm Crombach, Dr, Principal investigator, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172066
- Sponsor's protocol ID
- UKCR2014
- Status last verified
- Jul 2015
- First submitted
- 19 Jun 2014
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02172066
- Acronym / sponsor ID
- UKCR2014
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, Childhood maltreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- Vivo international e.V., Université Lumière de Bujumbura
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Jun 2014 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrative Exposure Therapy (NET) | Experimental | Behavioral: 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. |
| No treatment control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Pregnancy
- Current substance dependence
- Psychotic symptoms
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 Therapy (NET) | Behavioural | Narrative Exposure Therapy (NET) |
Primary outcome
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
2 secondary outcomes
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
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
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 20 Jul 2015.
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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.
Anselm Crombach, Dr principal investigator
University of Konstanz
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 (NET) in people with Posttraumatic Stress Disorder, run by University of Konstanz at 1 site in Burundi.
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 3 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 20 Jul 2015. 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 Burundi. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2015.