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

NCT00917397 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2014-06-18

No results posted yet for this study

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.

Conditions

  • Post-Traumatic Stress Disorder

Interventions

DRUG

Sertraline

varies

BEHAVIORAL

trauma-focused cognitive behavioural therapy

once a week

Sponsors & Collaborators

  • Caecilie Buhmann

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00917397 on ClinicalTrials.gov