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

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.

Stress management versus cognitive restructuring in trauma-affected refugees - A follow-up study on a pragmatic randomised trial.

BACKGROUND: There is a lack of research and consensus with respect to long-term effective treatments for trauma-affected refugees. The purpose of this follow-up study of a randomised clinical trial was to investigate the effectiveness of Stress Management (SM) versus Cognitive Restructuring (CR) in treating trauma-affected refugees, six and 18 months post-treatment, respectively. METHODS: From a total of 126 refugees with PTSD, the intention-to-treat sample in the original trial, 74 patients were present at the six-month follow-up (SM; n = 37, CR; n = 37) and 34 patients at the 18-month follow-up (SM; n = 14, CR; n = 20). During the trial, the patients had been offered a total of 16 psychotherapy sessions and 10 sessions with a medical doctor. RESULTS: Mixed regression analyses at six and 18-month follow-up showed a non-significant small reduction in PTSD symptoms at both follow-up points with no significant between-group differences between the two psychotherapeutic interventions. Statistically significant between-group treatment effects were, however, observed with the patients receiving SM having significantly reduced symptoms of somatisation measured by the Symptom Checklist (ß = 0.40), depression (ß = 0.29) and anxiety (ß = 0.37) (measured by the Hamilton Depression and Anxiety ratings) at 18 months post-treatment compared to the CR group. LIMITATIONS: Limitations to the present study include the dropout rate at follow-up(s). CONCLUSIONS: The findings suggest that the consolidation of coping strategies including relaxation, attention-diversion and behavioural activation in SM appears to be more beneficial than CR in reducing long-term somatisation, depression and anxiety symptoms for this population.