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Traumatized Refugees -Stress Management Versus Cognitive Re-structuring

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01362543
Enrollment
143
Registered
2011-05-30
Start date
2011-06-30
Completion date
2012-12-31
Last updated
2014-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD, Depression, Refugees, Trauma

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.

Interventions

OTHERCognitive behavioural therapy (stress management)

Following a manual

OTHERCognitive Behavioural Therapy (cognitive restructuring)

Following a manual

Sponsors

University of Copenhagen
CollaboratorOTHER
Mental Health Services in the Capital Region, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Change in depressive symptoms measured by the Hopkins Symptoms Checklist-25 (HSCL-25), depressive itemsBaseline, after 2 months and after 6 months
Change in anxiety symptoms measured by the Hopkins Symptom Checklist-25 (HSCL-25), anxiety itemsBaseline, after 2 months and after 6 months
Change in quality of life measured by the WHO-5Baseline, 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026