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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Caecilie Buhmann, Psykiatrisk Center Gentofte
ClinicalTrials.gov Identifier:
NCT00917397
First received: June 9, 2009
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Post-Traumatic Stress Disorder
Drug: Sertraline
Behavioral: trauma-focused cognitive behavioural therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Outcome of Treatment of Traumatised Refugees With Trauma-Focused Cognitive Behavioural Therapy and / or Antidepressants - a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Psykiatrisk Center Gentofte:

Primary Outcome Measures:
  • Score on Harvard Traume Questionnaire (PTSD) [ Time Frame: before entry, after 6 months treatment and at follow up ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: June 2009
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: psychotherapy
Trauma-focused cognitive behavioral therapy
Behavioral: trauma-focused cognitive behavioural therapy
once a week
Experimental: Drug
drug treatment and psychoeducation
Drug: Sertraline
varies
No Intervention: Waiting list
subjects randomized to waiting list
Experimental: Combination
Both drug and psychotherapy
Drug: Sertraline
varies
Behavioral: trauma-focused cognitive behavioural therapy
once a week

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult traumatised refugee with PTSD

Exclusion Criteria:

  • psychosis and drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917397

Locations
Denmark
Psykiatrisk Center Gentofte
Hellerup, Denmark, 2900
Sponsors and Collaborators
Caecilie Buhmann
  More Information

No publications provided

Responsible Party: Caecilie Buhmann, Dr, Psykiatrisk Center Gentofte
ClinicalTrials.gov Identifier: NCT00917397     History of Changes
Other Study ID Numbers: PTF1
Study First Received: June 9, 2009
Last Updated: June 17, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Psykiatrisk Center Gentofte:
Traumatized refugee
treatment
antidepressants
psychotherapy
PTSD in traumatized refugees

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014