NCT00917397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 18, 2014

Status Verified

June 1, 2014

Enrollment Period

4.8 years

First QC Date

June 9, 2009

Last Update Submit

June 17, 2014

Conditions

Post-Traumatic Stress Disorder

Keywords

Traumatized refugeetreatmentantidepressantspsychotherapyPTSD in traumatized refugees

Outcome Measures

Primary Outcomes (1)

  • Score on Harvard Traume Questionnaire (PTSD)

    before entry, after 6 months treatment and at follow up

Study Arms (4)

psychotherapy

EXPERIMENTAL

Trauma-focused cognitive behavioral therapy

Behavioral: trauma-focused cognitive behavioural therapy

Drug

EXPERIMENTAL

drug treatment and psychoeducation

Drug: Sertraline

Waiting list

NO INTERVENTION

subjects randomized to waiting list

Combination

EXPERIMENTAL

Both drug and psychotherapy

Drug: SertralineBehavioral: trauma-focused cognitive behavioural therapy

Interventions

SertralineDRUG

varies

CombinationDrug
trauma-focused cognitive behavioural therapyBEHAVIORAL

once a week

Combinationpsychotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult traumatised refugee with PTSD

You may not qualify if:

  • psychosis and drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psykiatrisk Center Gentofte

Hellerup, 2900, Denmark

Location

Related Publications (2)

  • Buhmann CB, Nordentoft M, Ekstroem M, Carlsson J, Mortensen EL. Long-term treatment effect of trauma-affected refugees with flexible cognitive behavioural therapy and antidepressants. Psychiatry Res. 2018 Jun;264:217-223. doi: 10.1016/j.psychres.2018.03.069. Epub 2018 Apr 4.

    PMID: 29655114DERIVED

  • Buhmann CB, Nordentoft M, Ekstroem M, Carlsson J, Mortensen EL. The effect of flexible cognitive-behavioural therapy and medical treatment, including antidepressants on post-traumatic stress disorder and depression in traumatised refugees: pragmatic randomised controlled clinical trial. Br J Psychiatry. 2016 Mar;208(3):252-9. doi: 10.1192/bjp.bp.114.150961. Epub 2015 Nov 5.

    PMID: 26541687DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 10, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 18, 2014

Record last verified: 2014-06

Locations

DK(1)