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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00917397
Enrollment
280
Registered
2009-06-10
Start date
2009-06-30
Completion date
2014-04-30
Last updated
2014-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Stress Disorder

Keywords

Traumatized refugee, treatment, antidepressants, psychotherapy, PTSD in traumatized refugees

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.

Interventions

DRUGSertraline

varies

BEHAVIORALtrauma-focused cognitive behavioural therapy

once a week

Sponsors

Caecilie Buhmann
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Adult traumatised refugee with PTSD

Exclusion criteria

* psychosis and drug abuse

Design outcomes

Primary

MeasureTime frame
Score on Harvard Traume Questionnaire (PTSD)before entry, after 6 months treatment and at follow up

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026