Posttraumatic Stress DisorderPhase 2NCT00623298
Narrative Exposure Therapy Versus Group Interpersonal Psychotherapy
A Phase 2 study testing Narrative Exposure Therapy, group IPT and 6 months-baseline in people with Posttraumatic Stress Disorder and Depression, run by University of Konstanz.
Trial summary
The present study is a pragmatic trial that investigates the efficacy and usefulness of two treatment modules in a sample of Rwandan genocide orphans: Narrative Exposure Therapy (NET) versus group-Interpersonal Psychotherapy (IPT). We used a half year baseline to measure the treatment-induced changes. Read more about this study
- Who is it for?
- Ages 13 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression, Narrative Exposure Therapy
- What is being tested?
- Narrative Exposure Therapy, group IPT and 6 months-baseline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Mar 2006
- Phase
- Phase 2
- 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 13 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Rwandan orphans who have experienced the genocide, who lost at least one parent during the genocide and who were no older than 18 years during the genocide
Who cannot join
- Mental retardation
- Psychotic symptoms or current drug or alcohol
About this study
Official title: Narrative Exposure Therapy Versus Group Interpersonal Psychotherapy -A Controlled Clinical Trial With Orphaned Survivors of the Rwandan Genocide
The present study is a pragmatic trial that investigates the efficacy and usefulness of two treatment modules in a sample of Rwandan genocide orphans: Narrative Exposure Therapy (NET) versus group-Interpersonal Psychotherapy (IPT). We used a half year baseline to measure the treatment-induced changes. We hypothesized that there would be a greater reduction in posttraumatic stress symptoms in the NET- than in the IPT-group and that IPT would be superior to NET in the reduction of depression symptoms.
Read the detailed description
The 1994 genocide of Rwanda has left countless children orphaned. 26 Rwandan orphans who fulfilled DSM-IV diagnosis of PTSD were offered participation in a controlled treatment trial. A group adaptation of Interpersonal Psychotherapy (IPT, n = 14) was compared to Narrative Exposure Therapy (NET, n = 12). Main outcome measures were symptoms of PTSD and depression assessed pre-treatment, 3 months after therapy (post-test) and 6 months after therapy (follow-up) using the CAPS, MINI and Hamilton Rating Scale. At post-test, participants in both treatment conditions showed reductions in posttraumatic stress symptoms and depression symptoms. At 6-month follow-up, NET proved to be more effective in the treatment of PTSD. Only 25% (n = 3) of NET-participants but 71% (n = 10) of the IPT-participants still fulfilled PTSD criteria at follow-up. Although there was a significant reduction in depression symptoms in both treatment groups from pre-test to follow-up, NET again proved to be more effective. This treatment-trial demonstrates that NET and group-IPT are suitable treatment modules even when most severe traumatic stress and difficult living conditions have led to chronic mental suffering.
- Conditions
- Posttraumatic Stress Disorder, Depression, Narrative Exposure Therapy, Interpersonal Psychotherapy
- Being tested
- Narrative Exposure Therapy, group IPT, 6 months-baseline
- Keywords
- Posttraumatic stress disorder, depression, Narrative Exposure Therapy, Interpersonal Psychotherapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure TherapyBehavioural
group IPTBehavioural
6 months-baselineOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | NET Receives: Behavioral: Narrative Exposure Therapy |
| 3 | No intervention | 6-months baseline Receives: Other: 6 months-baseline |
| 2 | Experimental | group IPT Receives: Behavioral: group IPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of posttraumatic stress disorder, symptoms of depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startJan 2005
- Study completionMar 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- vivo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623298
- Sponsor's protocol ID
- Fogr SOSS
- Status last verified
- Feb 2008
- First submitted
- 14 Feb 2008
- Last updated
- 26 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrative Exposure Therapy Versus Group Interpersonal Psychotherapy -A Controlled Clinical Trial With Orphaned Survivors of the Rwandan Genocide
- ClinicalTrials.gov ID
- NCT00623298
- Acronym / sponsor ID
- Fogr SOSS
- Conditions
- Posttraumatic Stress Disorder, Depression, Narrative Exposure Therapy, Interpersonal Psychotherapy
- Keywords
- Posttraumatic stress disorder, depression, Narrative Exposure Therapy, Interpersonal Psychotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- vivo
- Study start
- Jan 2005
- Study completion
- Mar 2006 (actual)
- First posted
- 26 Feb 2008 (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 present study is a pragmatic trial that investigates the efficacy and usefulness of two treatment modules in a sample of Rwandan genocide orphans: Narrative Exposure Therapy (NET) versus group-Interpersonal Psychotherapy (IPT). We used a half year baseline to measure the treatment-induced changes. We hypothesized that there would be a greater reduction in posttraumatic stress symptoms in the NET- than in the IPT-group and that IPT would be superior to NET in the reduction of depression symptoms.
Detailed description
The 1994 genocide of Rwanda has left countless children orphaned. 26 Rwandan orphans who fulfilled DSM-IV diagnosis of PTSD were offered participation in a controlled treatment trial. A group adaptation of Interpersonal Psychotherapy (IPT, n = 14) was compared to Narrative Exposure Therapy (NET, n = 12). Main outcome measures were symptoms of PTSD and depression assessed pre-treatment, 3 months after therapy (post-test) and 6 months after therapy (follow-up) using the CAPS, MINI and Hamilton Rating Scale. At post-test, participants in both treatment conditions showed reductions in posttraumatic stress symptoms and depression symptoms. At 6-month follow-up, NET proved to be more effective in the treatment of PTSD. Only 25% (n = 3) of NET-participants but 71% (n = 10) of the IPT-participants still fulfilled PTSD criteria at follow-up. Although there was a significant reduction in depression symptoms in both treatment groups from pre-test to follow-up, NET again proved to be more effective. This treatment-trial demonstrates that NET and group-IPT are suitable treatment modules even when most severe traumatic stress and difficult living conditions have led to chronic mental suffering.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Narrative Exposure TherapyNET |
| 3 | No intervention | Other: 6 months-baseline6-months baseline |
| 2 | Experimental | Behavioral: group IPTgroup IPT |
Who may qualify
- Ages
- 13 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Rwandan orphans who have experienced the genocide, who lost at least one parent during the genocide and who were no older than 18 years during the genocide
Key exclusion criteria (2 listed)
- Mental retardation
- Psychotic symptoms or current drug or alcohol
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 | Behavioural | 1 |
| group IPT | Behavioural | 2 |
| 6 months-baseline | Other | 3 |
Primary outcome
Symptoms of posttraumatic stress disorder, symptoms of depression
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Narrative Exposure Therapy, group IPT and 6 months-baseline in people with Posttraumatic Stress Disorder and Depression, run by University of Konstanz.
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 2 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: stopped early, as of the sponsor's last update on 26 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
Symptoms of posttraumatic stress disorder, symptoms of depression. 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 Feb 2008.