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Clinical Trials/NCT00917397
NCT00917397
Completed
Phase 4

The Outcome of Treatment of Traumatised Refugees With Trauma-Focused Cognitive Behavioural Therapy and / or Antidepressants - a Randomised Controlled Trial

Caecilie Buhmann1 site in 1 country280 target enrollmentJune 2009

Overview

Phase
Phase 4
Intervention
Sertraline
Conditions
Post-Traumatic Stress Disorder
Sponsor
Caecilie Buhmann
Enrollment
280
Locations
1
Primary Endpoint
Score on Harvard Traume Questionnaire (PTSD)
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
April 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Caecilie Buhmann
Responsible Party
Sponsor Investigator
Principal Investigator

Caecilie Buhmann

Dr

Psykiatrisk Center Gentofte

Eligibility Criteria

Inclusion Criteria

  • Adult traumatised refugee with PTSD

Exclusion Criteria

  • psychosis and drug abuse

Arms & Interventions

Combination

Both drug and psychotherapy

Intervention: Sertraline

psychotherapy

Trauma-focused cognitive behavioral therapy

Intervention: trauma-focused cognitive behavioural therapy

Drug

drug treatment and psychoeducation

Intervention: Sertraline

Combination

Both drug and psychotherapy

Intervention: trauma-focused cognitive behavioural therapy

Outcomes

Primary Outcomes

Score on Harvard Traume Questionnaire (PTSD)

Time Frame: before entry, after 6 months treatment and at follow up

Study Sites (1)

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