Posttraumatic Stress DisorderPhase 3NCT00550056
Treatment of Posttraumatic Stress Disorder by Trained Lay Counsellors in an African Refugee Settlement
A Phase 3 study testing Narrative Exposure Therapy and Trauma Counselling in people with Posttraumatic Stress Disorder, run by University of Konstanz at 1 site in Uganda.
Trial summary
The study is a pragmatic trial to study the efficacy of two active methods of psychotherapy for the treatment of posttraumatic stress disorder in a refugee camp in Africa. Treatment was administered by lay counsellors. 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 and Trauma Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 siteUganda
- Study dates
- Jan 2003to Apr 2004
- Phase
- Phase 3
- 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
- Diagnosis of posttraumatic stress disorder
Who cannot join
- Drug abuse
- Psychosis
- Mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Talking About Traumatic Events - A Randomized Controlled Dissemination Study of the Treatment of PTSD in an African Refugee Settlement
The study is a pragmatic trial to study the efficacy of two active methods of psychotherapy for the treatment of posttraumatic stress disorder in a refugee camp in Africa. Treatment was administered by lay counsellors.
Read the detailed description
Traumatic stress due to conflict and war causes major mental health problems in many resource-poor countries, especially those coping with displaced populations. There is a lack of intervention research in these populations.
Te purpose of this study was to examine whether trained lay counsellors can carry out effective treatment of PTSD in a refugee settlement.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Narrative Exposure Therapy, Trauma Counselling
- Keywords
- PTSD, Posttraumatic Stress Disorder, refugees, war
- 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
Six session of Narrative Exposure Therapy
Trauma CounsellingBehavioural
Six sessions of Trauma Counselling, using a variety of skills incl. exposure methods following the skills of the therapist
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | NET Receives: Behavioral: Narrative Exposure Therapy |
| 2 | Experimental | TC Receives: Behavioral: Trauma Counselling |
| 3 | No intervention | Monitoring Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale
Measured: 9 months
Secondary outcomes (2)
Expert diagnosis of PTSD established with CIDI interview
Measured: 9 months
Physical health symptoms assessed with a checklist
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startJan 2003
- Study completionApr 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Investigators
- Thomas Elbert, PhD, Principal investigator, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550056
- Sponsor's protocol ID
- NeEl-Ug-01
- Status last verified
- Oct 2007
- First submitted
- 25 Oct 2007
- Last updated
- 26 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Talking About Traumatic Events - A Randomized Controlled Dissemination Study of the Treatment of PTSD in an African Refugee Settlement
- ClinicalTrials.gov ID
- NCT00550056
- Acronym / sponsor ID
- NeEl-Ug-01
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Posttraumatic Stress Disorder, refugees, war
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jan 2003
- Study completion
- Apr 2004 (actual)
- First posted
- 26 Oct 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.
The study is a pragmatic trial to study the efficacy of two active methods of psychotherapy for the treatment of posttraumatic stress disorder in a refugee camp in Africa. Treatment was administered by lay counsellors.
Detailed description
Traumatic stress due to conflict and war causes major mental health problems in many resource-poor countries, especially those coping with displaced populations. There is a lack of intervention research in these populations.
Te purpose of this study was to examine whether trained lay counsellors can carry out effective treatment of PTSD in a refugee settlement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Narrative Exposure TherapyNET |
| 2 | Experimental | Behavioral: Trauma CounsellingTC |
| 3 | No intervention | –Monitoring Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of posttraumatic stress disorder
Key exclusion criteria (3 listed)
- Drug abuse
- Psychosis
- Mental retardation
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 TherapySix session of Narrative Exposure Therapy | Behavioural | 1 |
| Trauma CounsellingSix sessions of Trauma Counselling, using a variety of skills incl. exposure methods following the skills of the therapist | Behavioural | 2 |
Primary outcome
Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale
Time frame: 9 months
2 secondary outcomes
Expert diagnosis of PTSD established with CIDI interview
Time frame: 9 months
Physical health symptoms assessed with a checklist
Time frame: 9 months
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 26 Oct 2007.
Related trials for Posttraumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
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.
Thomas Elbert, PhD 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 Phase 3 study testing Narrative Exposure Therapy and Trauma Counselling in people with Posttraumatic Stress Disorder, 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 1 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 26 Oct 2007. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale (time frame: 9 months). 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 26 Oct 2007.