The Outcome of Treatment of Traumatised Refugees With Psychotherapy and/or Antidepressants
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...
Brief Summary
Official Title: “The Outcome of Treatment of Traumatised Refugees With Trauma-Focused Cognitive Behavioural Therapy and / or Antidepressants - a Randomised Controlled Trial”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: October 2012
Intervention(s) in this Clinical Trial
- Drug: Sertraline
- varies
- Behavioral: trauma-focused cognitive behavioural therapy
- once a week
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: psychotherapy
- Trauma-focused cognitive behavioral therapy
- Experimental: Drug
- drug treatment and psychoeducation
- No Intervention: Waiting list
- subjects randomized to waiting list
- Experimental: Combination
- Both drug and psychotherapy
Outcome Measures for this Clinical Trial
Primary Measures
- Score on Harvard Traume Questionnaire (PTSD)
- Time Frame: before entry, after 6 months treatment and at follow up
Safety Issue?: No
- Time Frame: before entry, after 6 months treatment and at follow up
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Adult traumatised refugee with PTSD
Exclusion Criteria:
- psychosis and drug abuse
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Caecilie Buhmann Other
Additional Information
Information obtained from ClinicalTrials.gov on February 02, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00917397
Study ID Number: PTF1
ClinicalTrials.gov Identifier: NCT00917397
Health Authority: Denmark: Danish Medicines Agency
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00917397
