The Outcome of Treatment of Traumatised Refugees With Psychotherapy and/or Antidepressants

Study Overview
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Brief Summary
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The purpose of the study is to investigate the effect of treatment of traumatized refugees with a diagnosis of Post-Traumatic Stress Disorder (PTSD). The existing evidence point towards antidepressants of the type SSRI and trauma-focused cognitive Behavioural Therapy being the most effective treatments of PTSD, but very little evidence of treatment effects exist for the group of multitraumatized refugees. This study therefore seeks to investigate the treatment effect of 6 months drug therapy with antidepressants (Sertraline and/ or Mianserine) and/or trauma-focused cognitive behavioral therapy. A total of 200 individual will undergo treatment. They will be randomized to 4 different groups: antidepressants, psychotherapy, a combination og drug and psychotherapy and a waiting list. Outcome measures include symptoms, life quality and function. Patients with a diagnosis of drug abuse or psychosis will not be included. The hypothesis is that a combination of antidepressants and psychotherapy will be more effective than either of the two treatment regimes on their own.

Official Title
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The Outcome of Treatment of Traumatised Refugees With Trauma-Focused Cognitive Behavioural Therapy and / or Antidepressants - a Randomised Controlled Trial

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Drug: Sertraline
* Behavioral: trauma-focused cognitive behavioural therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult traumatised refugee with PTSD Exclusion Criteria: psychosis and drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: psychotherapy<br>Trauma-focused cognitive behavioral therapy | Behavioral: trauma-focused cognitive behavioural therapy<br>* once a week<br>|
| Experimental: Drug<br>drug treatment and psychoeducation | Drug: Sertraline<br>* varies<br>|
| No Intervention: Waiting list<br>subjects randomized to waiting list | |
| Experimental: Combination<br>Both drug and psychotherapy | Drug: Sertraline<br>* varies<br>Behavioral: trauma-focused cognitive behavioural therapy<br>* once a week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Harvard Traume Questionnaire (PTSD) |  | before entry, after 6 months treatment and at follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatized refugee, treatment, antidepressants, psychotherapy, PTSD in traumatized refugees