Traumatized Refugees -Stress Management Versus Cognitive Re-structuring

May 13, 2014 updated by: Jessica Carlsson Lohmann, Mental Health Services in the Capital Region, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Ballerup, Denmark, 2750
        • Competence Centre for Transcultural Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stress Management
Other: Cognitive behavioural therapy (stress management)
Following a manual
Active Comparator: Cognitive restructuring
Other: Cognitive Behavioural Therapy (cognitive restructuring)
Following a manual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, after 2 months and after 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, after 2 months and after 6 months
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
Baseline, after 2 months and after 6 months
Change in quality of life measured by the WHO-5
Time Frame: Baseline, after 2 months and 6 months
Baseline, after 2 months and 6 months
Changes in functioning measured by the the Sheehan Disability Scale (SDS)
Time Frame: Baseline, after 2 months and 6 months
Baseline, after 2 months and 6 months
Achievement of goals set at beginning of psychotherapy using Goal Attainment Scaling (GAS)
Time Frame: After 6 months
After 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mental Health Services in the Capital Region, Denmark

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: Jessica M Carlsson Lohmann, MD, PhD, Competence Centre for Transcultural Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 24, 2011

First Submitted That Met QC Criteria

May 27, 2011

First Posted (Estimate)

May 30, 2011

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTF2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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