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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00917397
First Posted: June 10, 2009
Last Update Posted: June 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Caecilie Buhmann, Psykiatrisk Center Gentofte
  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: None (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 Caecilie Buhmann, Psykiatrisk Center Gentofte:

Primary Outcome Measures:
  • Score on Harvard Traume Questionnaire (PTSD) [ Time Frame: before entry, after 6 months treatment and at follow up ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult traumatised refugee with PTSD

Exclusion Criteria:

  • psychosis and drug abuse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917397


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Caecilie Buhmann, Dr, Psykiatrisk Center Gentofte
ClinicalTrials.gov Identifier: NCT00917397     History of Changes
Other Study ID Numbers: PTF1
First Submitted: June 9, 2009
First Posted: June 10, 2009
Last Update Posted: June 18, 2014
Last Verified: June 2014

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

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Antidepressive Agents
Sertraline
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs