Traumatized Refugees -Stress Management Versus Cognitive Re-structuring

Study Overview
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Brief Summary
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The Competence Centre for Transcultural Psychiatry is a clinic specialised in the treatment of traumatised refugees. There is a lack of studies on treatment effect in traumatised refugees. There are several studies indicating an effect of cognitive behavioural therapy (CBT) in Posttraumatic Stress Disorder (PTSD). A few studies point to that CBT could be effective in traumatised refugees. There are no studies examining if some methods used in CBT are more useful than others in traumatised refugees. The aim of this study is to examine the effect of CBT with focus on Stress Management versus cognitive restructuring. Patients included in this study will be randomised to either Stress Management or cognitive restructuring. All referred patients will receive medical treatment as usual (described in the clinic's manual for medical doctors, 2011). All patients that fulfill the inclusion criteria will be included in the study. Hopefully this study will contribute to improve the psychotherapeutic treatment offered to traumatised refugees.

Official Title
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Treatment With Cognitive Behavioural Therapy in Traumatised Refugees - Stress Management Versus Cognitive Restructuring - a Randomised Clinical Trial

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Other: Cognitive behavioural therapy (stress management)
* Other: Cognitive Behavioural Therapy (cognitive restructuring)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Refugee or patient that has been reunified with family member being a refugee. Symptoms of PTSD in accordance with International Classification of Diseases-10 (ICD-10) research criteria. Trauma in the past such as imprisonment, torture (according to UN definition), war experiences. Referred by a medical doctor. Motivated for treatment. Informed consent. Exclusion Criteria: Severe psychotic illness such as schizophrenia or bipolar disorder Drug abuse Patients admitted to in ward treatment No informed consent

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Stress Management<br> | Other: Cognitive behavioural therapy (stress management)<br>* Following a manual<br>|
| Active Comparator: Cognitive restructuring<br> | Other: Cognitive Behavioural Therapy (cognitive restructuring)<br>* Following a manual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire (HTQ) |  | Baseline, after 2 months and after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms measured by the Hopkins Symptoms Checklist-25 (HSCL-25), depressive items |  | Baseline, after 2 months and after 6 months | 
| Change in anxiety symptoms measured by the Hopkins Symptom Checklist-25 (HSCL-25), anxiety items |  | Baseline, after 2 months and after 6 months | 
| Change in quality of life measured by the WHO-5 |  | Baseline, after 2 months and 6 months | 
| Changes in functioning measured by the the Sheehan Disability Scale (SDS) |  | Baseline, after 2 months and 6 months | 
| Achievement of goals set at beginning of psychotherapy using Goal Attainment Scaling (GAS) |  | After 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Depression, Refugees, Trauma