Traumatized Refugees -Stress Management Versus Cognitive Re-structuring

Mental Health Services in the Capital Region, Denmark

Status and phase: Completed; Phase 3

Conditions: Posttraumatic Stress Disorder

Treatments: Other: Cognitive Behavioural Therapy (cognitive restructuring); Other: Cognitive behavioural therapy (stress management)

Study type: Interventional

Funder types: Other

Identifiers

NCT01362543

PTF2

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

Stress Management

Active Comparator group

Treatment:

Other: Cognitive behavioural therapy (stress management)

Cognitive restructuring

Active Comparator group

Treatment:

Other: Cognitive Behavioural Therapy (cognitive restructuring)