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

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. Identifier: NCT00917397
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : June 18, 2014
Information provided by (Responsible Party):
Caecilie Buhmann, Psykiatrisk Center Gentofte

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
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
Study Start Date : June 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Sertraline

Arm Intervention/treatment
Experimental: psychotherapy
Trauma-focused cognitive behavioral therapy
Behavioral: trauma-focused cognitive behavioural therapy
once a week

Experimental: Drug
drug treatment and psychoeducation
Drug: Sertraline

No Intervention: Waiting list
subjects randomized to waiting list
Experimental: Combination
Both drug and psychotherapy
Drug: Sertraline

Behavioral: trauma-focused cognitive behavioural therapy
once a week

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Adult traumatised refugee with PTSD

Exclusion Criteria:

  • psychosis and drug abuse

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 identifier (NCT number): NCT00917397

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Psykiatrisk Center Gentofte
Hellerup, Denmark, 2900
Sponsors and Collaborators
Caecilie Buhmann
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Caecilie Buhmann, Dr, Psykiatrisk Center Gentofte Identifier: NCT00917397    
Other Study ID Numbers: PTF1
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: June 18, 2014
Last Verified: June 2014
Keywords provided by Caecilie Buhmann, Psykiatrisk Center Gentofte:
Traumatized refugee
PTSD in traumatized refugees
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs