Clinical trial NCT01362543: Traumatized Refugees -Stress Management Versus Cognitive Re-structuring
Official title: Treatment With Cognitive Behavioural Therapy in Traumatised Refugees - Stress Management Versus Cognitive Restructuring - a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
Depression
Refugees
Trauma
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2011-05-30
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire (HTQ)
timeFrame: Baseline, after 2 months and after 6 months
Secondary outcomes:
measure: Change in depressive symptoms measured by the Hopkins Symptoms Checklist-25 (HSCL-25), depressive items
timeFrame: Baseline, after 2 months and after 6 months
measure: Change in anxiety symptoms measured by the Hopkins Symptom Checklist-25 (HSCL-25), anxiety items
timeFrame: Baseline, after 2 months and after 6 months
measure: Change in quality of life measured by the WHO-5
timeFrame: Baseline, after 2 months and 6 months
measure: Changes in functioning measured by the the Sheehan Disability Scale (SDS)
timeFrame: Baseline, after 2 months and 6 months
measure: Achievement of goals set at beginning of psychotherapy using Goal Attainment Scaling (GAS)
timeFrame: After 6 months
Other outcomes:
Locations:
city: Ballerup
country: Denmark
facility: Competence Centre for Transcultural Psychiatry
Study officials:
affiliation: Competence Centre for Transcultural Psychiatry
name: Jessica M Carlsson Lohmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: