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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917397
• Other study ID #: PTF1
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2009
• Last updated: June 17, 2014
• Start date: June 2009
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Psykiatrisk Center Gentofte
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult traumatised refugee with PTSD

Exclusion Criteria:

• psychosis and drug abuse

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Sertraline
varies

Behavioral:
• trauma-focused cognitive behavioural therapy
once a week

Locations

Country	Name	City	State
Denmark	Psykiatrisk Center Gentofte	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Caecilie Buhmann

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on Harvard Traume Questionnaire (PTSD)		before entry, after 6 months treatment and at follow up	No