Stress Disorders, Post-Traumatic Clinical Trial
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)
| Verified date | July 2008 |
| Source | University of Konstanz |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 85 |
| Est. completion date | November 2009 |
| Est. primary completion date | November 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years to 25 Years |
| Eligibility |
Inclusion Criteria: - clinical diagnosis of PTSD (Post-Traumatic Stress Disorder) derived from expert interviews - member of the group of formerly abducted people or former child soldiers Exclusion Criteria: - current substance dependence - mental retardation - psychotic disorder |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Uganda | Vivo Counselling Centre | Anaka | Amuru |
| Lead Sponsor | Collaborator |
|---|---|
| University of Konstanz | German Research Foundation |
Uganda,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale) | 3 months, 6 months and 1 year after completion of treatment | No | |
| Secondary | 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 | 3 months, 6 months and 1 year after completion of treatment | No |
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