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Completed

NCT Number: NCT01362543

Traumatized Refugees -Stress Management Versus Cognitive Re-structuring

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.

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Key information

Conditions

Posttraumatic Stress Disorder Behavior Behavioral Symptoms Depression Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Competence Centre for Transcultural Psychiatry

Ballerup Municipality, 2750, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioural therapy (stress management)

Other

Following a manual

Cognitive Behavioural Therapy (cognitive restructuring)

Other

Following a manual

Primary outcomes

  1. Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire (HTQ)

    Time frame: Baseline, after 2 months and after 6 months

Secondary outcomes

  1. Change in depressive symptoms measured by the Hopkins Symptoms Checklist-25 (HSCL-25), depressive items

    Time frame: Baseline, after 2 months and after 6 months

  2. Change in anxiety symptoms measured by the Hopkins Symptom Checklist-25 (HSCL-25), anxiety items

    Time frame: Baseline, after 2 months and after 6 months

  3. Change in quality of life measured by the WHO-5

    Time frame: Baseline, after 2 months and 6 months

  4. Changes in functioning measured by the the Sheehan Disability Scale (SDS)

    Time frame: Baseline, after 2 months and 6 months

  5. Achievement of goals set at beginning of psychotherapy using Goal Attainment Scaling (GAS)

    Time frame: After 6 months

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 30, 2011
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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