The Outcome of Treatment of Traumatised Refugees With Psychotherapy and/or Antidepressants

Phase 4

Completed

• Conditions: Post-Traumatic Stress Disorder
• Interventions: Behavioral: trauma-focused cognitive behavioural therapy; Drug: Sertraline

• Registration Number: NCT00917397
• Lead Sponsor: Caecilie Buhmann

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Adult traumatised refugee with PTSD

Exclusion Criteria

• psychosis and drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
psychotherapy	trauma-focused cognitive behavioural therapy	Trauma-focused cognitive behavioral therapy
Drug	Sertraline	drug treatment and psychoeducation
Combination	trauma-focused cognitive behavioural therapy	Both drug and psychotherapy
Combination	Sertraline	Both drug and psychotherapy

Primary Outcome Measures

Name	Time	Method
Score on Harvard Traume Questionnaire (PTSD)	before entry, after 6 months treatment and at follow up

Trial Locations

Locations (1)

Psykiatrisk Center Gentofte; 🇩🇰 Hellerup, Denmark