Sertraline versus venlafaxine combined with psychotherapy in trauma-affected refugees – a follow-up study on a pragmatic randomised trial

Abstract

Background

Research on long-term pharmacotherapy for trauma-affected refugees is scarce. The purpose of this follow-up study of a randomised trial was to investigate the effects of sertraline compared to venlafaxine in combination with psychotherapy, 6 and 18 months after end of trial.

Method

The primary outcome was PTSD symptoms, measured by the Harvard Trauma Questionnaire (HTQ). The secondary outcomes included: Hopkins Symptom Checklist-25 (HSCL-25), somatisation items of the Symptoms Checklist-90 (SCL), pain on a visual analogue scale, well-being on the WHO-5, Sheehan Disability Scale, Hamilton Depression and Anxiety scales and Global Assessment of Functioning. Moreover, the shorter version of the Recent Life Events (IRLE) was adopted to obtain information regarding the patients’ treatment and life events between the follow-up periods.

Results

Out of 195 patients eligible for intention-to-treat analyses during trial, 116 participated in the 6-month follow-up and 97 participated in the 18-month follow-up. The results of our intention-to-treat analyses revealed no significant long-term differences between the groups on the primary outcome assessing PTSD symptoms (HTQ). For the secondary outcomes significant differences were found at the 18-month follow-up in favour of venlafaxine assessing symptoms of anxiety, depression and somatisation (HSCL-25 and SCL), although only in intention-to-treat and not per-protocol analyses.

Conclusions

No conclusions could be drawn due to conflicting results between our intention-to-treat and per-protocol analyses.

Keywords:

• PTSD
• trauma
• refugees
• sertraline
• venlafaxine, pharmacotherapy

Authors contributions

Author Maria Barhoma was the primary investigator of the study, conducted the statistical analyses and wrote the first drafts of this paper. Author Charlotte Sonne was part of the team designing the study, supervised and provided several critical revisions of the article throughout. Author Jessica Carlsson was part of the team designing the study, supervised and provided several critical revisions of the article throughout. All authors have approved the final manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

The data supporting this study’s findings are available from the corresponding author on reasonable request.

Additional information

Funding

This study was funded by The Health Foundation (Helsefonden), The Tryg Foundation (TrygFonden), The Research foundation of the Capital Region of Denmark and the Research foundation for the Mental Health Services - Capital Region of Denmark.