Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study

Abstract

BackgroundThe prevalence of trauma-related psychiatric disorders is high among refugees. Despite this, little is known about the effect of pharmacological treatment for this patient group. The objective of the present study was therefore to examine differences in the effects of venlafaxine and sertraline on Post-Traumatic Stress Disorder (PTSD), depression and functional impairment in trauma-affected refugees.MethodsThe study was a randomised pragmatic trial comparing venlafaxine and sertraline in combination with psychotherapy and social counselling. PTSD symptoms were measured on the Harvard Trauma Questionnaire – part IV, which was the primary outcome measure. Other outcome measures included: Hopkins Symptom Check List-25 (depression and anxiety), Social Adjustment Scale – short version (social functioning), WHO-5 Well-being Index (quality of life), Crisis Support Scale (support from social network), Sheehan Disability Scale (disability in three areas of functioning), Hamilton Depression and Anxiety scale, the somatisation items of the Symptoms Checklist-90, Global Assessment of Functioning scales and the summarised score of pain in four body areas rated on visual analogue scales.ResultsTwo hundred seven adult refugee patients were included in the trial (98 in the venlafaxine and 109 in the sertraline group). Of these, 195 patients were eligible for intention-to-treat analyses. Small but significant pre-treatment to post-treatment differences were found on the Harvard Trauma Questionnaire and a number of other ratings in both groups. On the primary outcome measure, no difference was found in treatment effect between the sertraline and venlafaxine group. A significant group difference was found in favour of sertraline on the Sheehan Disability Scale.ConclusionSertraline had a slightly better outcome than venlafaxine on some of the secondary outcome measures, but not on the primary outcome measure. Furthermore, a higher percentage of dropouts was found in the venlafaxine group compared to the sertraline group. Although this could indicate that sertraline was better tolerated, which is supported by other studies, a final conclusion on tolerability cannot be drawn from the current study due to lack of systematic reporting of side effects.Trial RegistrationClinicalTrials.gov NCT01569685. Registration date: 28/2/12Electronic supplementary materialThe online version of this article (doi:10.1186/s12888-016-1081-5) contains supplementary material, which is available to authorized users.

Variations in psychiatric morbidity between traumatized Norwegian, refugees and other immigrant patients in Oslo

“…A previous cross-sectional study from Norway has found particularly high rates of comorbid depression with PTSD in multi-traumatized refugees in outpatient clinics [30]. Similar results have been found internationally [33]. In our study, however, we were able to compare the types of disorders among the refugees with those of the native Norwegian population and other immigrants in the same clinical setting.…”

Trauma-affected refugees treated with basic body awareness therapy or mixed physical activity as augmentation to treatment as usual—A pragmatic randomised controlled trial

“…A difference of less than ½ SD was considered less relevant from a clinical perspective. However, due to a smaller number than expected of male patients with a high HTQ score (which we stratified for in accordance with the average level of HTQ-score in previous RCTs conducted at CTP [24,25]) a larger number was included. Thus, the final number of included patients was 338.…”

“…The trial was conducted at the Competence Centre for Transcultural Psychiatry (CTP), a specialist outpatient clinic treating traumaaffected refugees in the Capital Region of Denmark. Since 2009, CTP has been conducting a series of randomised controlled pragmatic trials [24][25][26]. The target population at CTP comprises trauma-affected refugees (approximately 75%) and migrants with other psychiatric illnesses (approximately 25%).…”

Utility of group treatment for trauma‐affected refugees in specialised outpatient clinics in Denmark: A mixed methods study of practitioners’ experiences

“…Resettled refugees are vulnerable to development of mental illness due to multiple adverse life events, such as traumatic experiences and psychosocial stressors before, during and after flight (Kirmayer et al., ; Steel et al., ). Trauma‐affected refugees resettled in Denmark can exhibit delayed treatment‐seeking patterns, on average 15 years after traumatic exposure (Palic, Kappel, Nielsen, Carlsson, & Bech, ; Sonne, Carlsson, Bech, Elklit, & Mortensen, ). Thus, they often display chronic and complex psychiatric comorbidity, as well as high levels of disability (Palic et al., ).…”

“…Trauma-affected refugees resettled in Denmark can exhibit delayed treatment-seeking patterns, on average 15 years after traumatic exposure (Palic, Kappel, Nielsen, Carlsson, & Bech, 2014;Sonne, Carlsson, Bech, Elklit, & Mortensen, 2016). Thus, they often display chronic and complex psychiatric comorbidity, as well as high levels of disability (Palic et al, 2014).…”