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Traumatized Refugees -Stress Management Versus Cognitive Re-structuring

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Cognitive behavioural therapy (stress management)
Cognitive Behavioural Therapy (cognitive restructuring)
Sponsored by
Mental Health Services in the Capital Region, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, Depression, Refugees, Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Competence Centre for Transcultural Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Stress Management

Cognitive restructuring

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in depressive symptoms measured by the Hopkins Symptoms Checklist-25 (HSCL-25), depressive items
Change in anxiety symptoms measured by the Hopkins Symptom Checklist-25 (HSCL-25), anxiety items
Change in quality of life measured by the WHO-5
Changes in functioning measured by the the Sheehan Disability Scale (SDS)
Achievement of goals set at beginning of psychotherapy using Goal Attainment Scaling (GAS)

Full Information

First Posted
May 24, 2011
Last Updated
May 13, 2014
Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01362543
Brief Title
Traumatized Refugees -Stress Management Versus Cognitive Re-structuring
Official Title
Treatment With Cognitive Behavioural Therapy in Traumatised Refugees - Stress Management Versus Cognitive Restructuring - a Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
University of Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, Depression, Refugees, Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress Management
Arm Type
Active Comparator
Arm Title
Cognitive restructuring
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Cognitive behavioural therapy (stress management)
Intervention Description
Following a manual
Intervention Type
Other
Intervention Name(s)
Cognitive Behavioural Therapy (cognitive restructuring)
Intervention Description
Following a manual
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
Change in quality of life measured by the WHO-5
Time Frame
Baseline, after 2 months and 6 months
Title
Changes in functioning measured by the the Sheehan Disability Scale (SDS)
Time Frame
Baseline, after 2 months and 6 months
Title
Achievement of goals set at beginning of psychotherapy using Goal Attainment Scaling (GAS)
Time Frame
After 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica M Carlsson Lohmann, MD, PhD
Organizational Affiliation
Competence Centre for Transcultural Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Competence Centre for Transcultural Psychiatry
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark

12. IPD Sharing Statement

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Traumatized Refugees -Stress Management Versus Cognitive Re-structuring

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