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

NCT ID: NCT00917397

Last Updated: 2014-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2014-04-30

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.

Conditions

Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

psychotherapy

Trauma-focused cognitive behavioral therapy

Group Type: EXPERIMENTAL

trauma-focused cognitive behavioural therapy

Intervention Type: BEHAVIORAL

once a week

Drug

drug treatment and psychoeducation

Group Type: EXPERIMENTAL

Sertraline

Intervention Type: DRUG

varies

Waiting list

subjects randomized to waiting list

Group Type: NO_INTERVENTION

No interventions assigned to this group

Combination

Both drug and psychotherapy

Group Type: EXPERIMENTAL

Sertraline

Intervention Type: DRUG

varies

trauma-focused cognitive behavioural therapy

Intervention Type: BEHAVIORAL

once a week

Interventions

Sertraline

varies

Intervention Type: DRUG

trauma-focused cognitive behavioural therapy

once a week

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult traumatised refugee with PTSD

Exclusion Criteria

• psychosis and drug abuse

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Caecilie Buhmann

OTHER

Sponsor Role: lead

Responsible Party

Caecilie Buhmann

Dr

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Psykiatrisk Center Gentofte

Hellerup, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 29655114 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26541687 (View on PubMed)

Other Identifiers

PTF1

Identifier Type: -

Identifier Source: org_study_id