Traumatized Refugees -Stress Management Versus Cognitive Re-structuring

Phase 3

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Other: Cognitive behavioural therapy (stress management); Other: Cognitive Behavioural Therapy (cognitive restructuring)

• Registration Number: NCT01362543
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-05-30
• Study Start: 2011-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress Management	Cognitive behavioural therapy (stress management)	-
Cognitive restructuring	Cognitive Behavioural Therapy (cognitive restructuring)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Competence Centre for Transcultural Psychiatry; 🇩🇰 Ballerup, Denmark