Back to resultsThe Outcome of Treatment of Traumatised Refugees With Psychotherapy and/or Antidepressants
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Sertraline
trauma-focused cognitive behavioural therapy
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Traumatized refugee, treatment, antidepressants, psychotherapy, PTSD in traumatized refugees
Eligibility Criteria
Inclusion Criteria:
- Adult traumatised refugee with PTSD
Exclusion Criteria:
- psychosis and drug abuse
Sites / Locations
- Psykiatrisk Center Gentofte
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
No Intervention
Experimental
Arm Label
psychotherapy
Drug
Waiting list
Combination
Arm Description
Trauma-focused cognitive behavioral therapy
drug treatment and psychoeducation
subjects randomized to waiting list
Both drug and psychotherapy
Outcomes
Primary Outcome Measures
Score on Harvard Traume Questionnaire (PTSD)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00917397
Brief Title
The Outcome of Treatment of Traumatised Refugees With Psychotherapy and/or Antidepressants
Official Title
The Outcome of Treatment of Traumatised Refugees With Trauma-Focused Cognitive Behavioural Therapy and / or Antidepressants - a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Caecilie Buhmann
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to investigate the effect of treatment of traumatized refugees with a diagnosis of Post-Traumatic Stress Disorder (PTSD). The existing evidence point towards antidepressants of the type SSRI and trauma-focused cognitive Behavioural Therapy being the most effective treatments of PTSD, but very little evidence of treatment effects exist for the group of multitraumatized refugees. This study therefore seeks to investigate the treatment effect of 6 months drug therapy with antidepressants (Sertraline and/ or Mianserine) and/or trauma-focused cognitive behavioral therapy. A total of 200 individual will undergo treatment. They will be randomized to 4 different groups: antidepressants, psychotherapy, a combination og drug and psychotherapy and a waiting list. Outcome measures include symptoms, life quality and function. Patients with a diagnosis of drug abuse or psychosis will not be included. The hypothesis is that a combination of antidepressants and psychotherapy will be more effective than either of the two treatment regimes on their own.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Traumatized refugee, treatment, antidepressants, psychotherapy, PTSD in traumatized refugees
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
psychotherapy
Arm Type
Experimental
Arm Description
Trauma-focused cognitive behavioral therapy
Arm Title
Drug
Arm Type
Experimental
Arm Description
drug treatment and psychoeducation
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
subjects randomized to waiting list
Arm Title
Combination
Arm Type
Experimental
Arm Description
Both drug and psychotherapy
Intervention Type
Drug
Intervention Name(s)
Sertraline
Intervention Description
varies
Intervention Type
Behavioral
Intervention Name(s)
trauma-focused cognitive behavioural therapy
Intervention Description
once a week
Primary Outcome Measure Information:
Title
Score on Harvard Traume Questionnaire (PTSD)
Time Frame
before entry, after 6 months treatment and at follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult traumatised refugee with PTSD
Exclusion Criteria:
psychosis and drug abuse
Facility Information:
Facility Name
Psykiatrisk Center Gentofte
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
29655114
Citation
Buhmann CB, Nordentoft M, Ekstroem M, Carlsson J, Mortensen EL. Long-term treatment effect of trauma-affected refugees with flexible cognitive behavioural therapy and antidepressants. Psychiatry Res. 2018 Jun;264:217-223. doi: 10.1016/j.psychres.2018.03.069. Epub 2018 Apr 4.
Results Reference
derived
PubMed Identifier
26541687
Citation
Buhmann CB, Nordentoft M, Ekstroem M, Carlsson J, Mortensen EL. The effect of flexible cognitive-behavioural therapy and medical treatment, including antidepressants on post-traumatic stress disorder and depression in traumatised refugees: pragmatic randomised controlled clinical trial. Br J Psychiatry. 2016 Mar;208(3):252-9. doi: 10.1192/bjp.bp.114.150961. Epub 2015 Nov 5.
Results Reference
derived
Learn more about this trial
The Outcome of Treatment of Traumatised Refugees With Psychotherapy and/or Antidepressants
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