Stress Disorders, Post-TraumaticNCT00552006
Treatment of Formerly Abducted Children (FAC) in Uganda
A study testing Narrative Exposure Therapy and Academic Counseling in people with Stress Disorders, Post-Traumatic, run by University of Konstanz at 1 site in Uganda.
Trial summary
In the aftermath of traumatic experiences like natural disasters or man-caused traumatic events, such as war experiences, a substantial part of the affected individuals develop a number of psychological symptoms. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Narrative Exposure Therapy and Academic Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUganda
- Study dates
- Nov 2007to Nov 2009
- 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 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinical diagnosis of PTSD (Post-Traumatic Stress Disorder) derived from expert interviews
- member of the group of formerly abducted people or former child soldiers
Who cannot join
- current substance dependence
- mental retardation
- psychotic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus an Attention Control Condition (AC) in Reducing Trauma Related Symptoms in Formerly Abducted Children and Former Child Soldiers Suffering From Posttraumatic Stress Disorder (PTSD)
In the aftermath of traumatic experiences like natural disasters or man-caused traumatic events, such as war experiences, a substantial part of the affected individuals develop a number of psychological symptoms. The characteristic symptom pattern occurring in the aftermath of traumatic events is called posttraumatic stress disorder (PTSD) and includes functional impairment of the affected individuals. The investigators want to test whether Narrative Exposure Therapy (NET) is an effective tool in reducing trauma related symptoms in formerly abducted children and youths and former child soldiers, when applied by lay personnel.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Narrative Exposure Therapy, Academic Counseling
- Keywords
- PTSD, Treatment, Randomized Controlled Clinical Trial, Combat, Child Soldiers, Dissemination, Narrative Exposure Therapy, Africa
- 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 TherapyBehavioural
Also called NET
Narrative Exposure Therapy (NET) is based on Testimony Therapy in combination with cognitive behavioural exposure techniques and elements of client-centered counselling. In cooperation with the therapist the clients can restore their autobiographic memories about their traumatic experiences. In this way fragmentary memories are transformed into a coherent narrative structure. This practice enables the processing of painful emotions and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. Therapeutic aims are the reduction of PTSD-Symptomload via activation of fear-network and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography.
NET will be applied in eight sessions (90-120min/session) in a standardized, manualized manner.
Academic CounselingBehavioural
Also called AC
Missing time in educational life is one major issue for formerly abducted people. The Academic Counseling (AC) intervention is an active Control condition and improves English skills and works at the same time on concentration, learning and memory abilities. The clients will gain some of the abilities and skills they might have lost or developed weaknesses in due to their abduction.
AC will be applied in eight sessions (90-120min/session) in a standardized, manualized manner.
| Study group | Role | What they receive |
|---|---|---|
| NET | Experimental | Not described Receives: Behavioral: Narrative Exposure Therapy |
| AC | Active comparator | Not described Receives: Behavioral: Academic Counseling |
| WL | No intervention | Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale)
Measured: 3 months, 6 months and 1 year after completion of treatment
Secondary outcomes (1)
Load of depressive symptoms measured via the MINI, strength of suicidal ideation measured via the MINI, functionality measured via the CAPS, feelings of guilt measured via the CAPS, stigmatization measured via an adapted version of the PSQ
Measured: 3 months, 6 months and 1 year after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Investigators
- Frank Neuner, Univ.-Prof. Dr., Principal investigator, Bielefeld UniversityThomas Elbert, Univ.-Prof. Dr., Principal investigator, University of KonstanzVerena Ertl, Dipl.-Psych. (MSc), Study director, Bielefeld University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552006
- Sponsor's protocol ID
- NE 1390/2-1
- Status last verified
- Jul 2008
- First submitted
- 31 Oct 2007
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ertl V, Pfeiffer A, Schauer E, Elbert T, Neuner F. Community-implemented trauma therapy for former child soldiers in Northern Uganda: a randomized controlled trial. JAMA. 2011 Aug 3;306(5):503-12. doi: 10.1001/jama.2011.1060.
PubMed 21813428
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus an Attention Control Condition (AC) in Reducing Trauma Related Symptoms in Formerly Abducted Children and Former Child Soldiers Suffering From Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT00552006
- Acronym / sponsor ID
- NE 1390/2-1
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, Treatment, Randomized Controlled Clinical Trial, Combat, Child Soldiers, Dissemination, Narrative Exposure Therapy, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 1 Nov 2007 (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 traumatic experiences like natural disasters or man-caused traumatic events, such as war experiences, a substantial part of the affected individuals develop a number of psychological symptoms. The characteristic symptom pattern occurring in the aftermath of traumatic events is called posttraumatic stress disorder (PTSD) and includes functional impairment of the affected individuals. The investigators want to test whether Narrative Exposure Therapy (NET) is an effective tool in reducing trauma related symptoms in formerly abducted children and youths and former child soldiers, when applied by lay personnel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NET | Experimental | Behavioral: Narrative Exposure Therapy |
| AC | Active comparator | Behavioral: Academic Counseling |
| WL | No intervention | –Waiting list |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- clinical diagnosis of PTSD (Post-Traumatic Stress Disorder) derived from expert interviews
- member of the group of formerly abducted people or former child soldiers
Key exclusion criteria (3 listed)
- current substance dependence
- mental retardation
- psychotic disorder
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 TherapyAlso: NETNarrative Exposure Therapy (NET) is based on Testimony Therapy in combination with cognitive behavioural exposure techniques and elements of client-centered counselling. In cooperation with the therapist the clients can restore their autobiographic memories about their traumatic experiences. In this way fragmentary memories are transformed into a coherent narrative structure. This practice enables the processing of painful emotions and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. Therapeutic aims are the reduction of PTSD-Symptomload via activation of fear-network and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography. NET will be applied in eight sessions (90-120min/session) in a standardized, manualized manner. | Behavioural | NET |
| Academic CounselingAlso: ACMissing time in educational life is one major issue for formerly abducted people. The Academic Counseling (AC) intervention is an active Control condition and improves English skills and works at the same time on concentration, learning and memory abilities. The clients will gain some of the abilities and skills they might have lost or developed weaknesses in due to their abduction. AC will be applied in eight sessions (90-120min/session) in a standardized, manualized manner. | Behavioural | AC |
Primary outcome
Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale)
Time frame: 3 months, 6 months and 1 year after completion of treatment
1 secondary outcome
Load of depressive symptoms measured via the MINI, strength of suicidal ideation measured via the MINI, functionality measured via the CAPS, feelings of guilt measured via the CAPS, stigmatization measured via an adapted version of the PSQ
Time frame: 3 months, 6 months and 1 year after completion of treatment
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 8 Mar 2011.
- Derived from this study: PubMed 21813428Ertl V, Pfeiffer A, Schauer E, Elbert T, Neuner F. Community-implemented trauma therapy for former child soldiers in Northern Uganda: a randomized controlled trial. JAMA. 2011 Aug 3;306(5):503-12. doi: 10.1001/jama.2011.1060.
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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.
Frank Neuner, Univ.-Prof. Dr. principal investigator
Bielefeld University
Thomas Elbert, Univ.-Prof. Dr. principal investigator
University of Konstanz
Verena Ertl, Dipl.-Psych. (MSc) study director
Bielefeld University
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 and Academic Counseling in people with Stress Disorders, Post-Traumatic, run by University of Konstanz at 1 site in Uganda.
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 2 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 8 Mar 2011. 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 Uganda. 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?
Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale) (time frame: 3 months, 6 months and 1 year after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00552006, which also lists 1 linked publication.
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 8 Mar 2011.