Traumatized Refugees -Stress Management Versus Cognitive Re-structuring

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362543
• Other study ID #: PTF2
• Status: Completed
• Phase: Phase 3
• First received: May 24, 2011
• Last updated: May 13, 2014
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Cognitive behavioural therapy (stress management)
Following a manual
• Cognitive Behavioural Therapy (cognitive restructuring)
Following a manual

Locations

Country	Name	City	State
Denmark	Competence Centre for Transcultural Psychiatry	Ballerup

Sponsors (2)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire (HTQ)		Baseline, after 2 months and after 6 months	No
Secondary	Change in depressive symptoms measured by the Hopkins Symptoms Checklist-25 (HSCL-25), depressive items		Baseline, after 2 months and after 6 months	No
Secondary	Change in anxiety symptoms measured by the Hopkins Symptom Checklist-25 (HSCL-25), anxiety items		Baseline, after 2 months and after 6 months	No
Secondary	Change in quality of life measured by the WHO-5		Baseline, after 2 months and 6 months	No
Secondary	Changes in functioning measured by the the Sheehan Disability Scale (SDS)		Baseline, after 2 months and 6 months	No
Secondary	Achievement of goals set at beginning of psychotherapy using Goal Attainment Scaling (GAS)		After 6 months	No