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