Abstract
BackgroundSleep disturbances are often referred to as a hallmark and as core symptoms of post-traumatic stress disorder (PTSD). Untreated sleep disturbances can contribute to the maintenance and exacerbation of PTSD symptoms, which may diminish treatment response and constitute a risk factor for poor treatment outcome. Controlled trials on treatment of sleep disturbances in refugees suffering from PTSD are scarce. The present study aims to examine sleep-enhancing treatment in refugees with PTSD. We aim to assess if add-on treatment with mianserin and/or Imagery Rehearsal Therapy (IRT) to treatment as usual (TAU) for PTSD improves sleep disturbances. We will study the relation between sleep disturbances, PTSD symptoms, psychosocial functioning and quality of life.MethodsThe study is a randomised controlled superiority trial with a 2 × 2 factorial design. The study will include 230 trauma-affected refugees.The patients are randomised into four groups. All four groups receive TAU – an interdisciplinary treatment approach covering a period of 6–8 months with pharmacological treatment, physiotherapy, psychoeducation and manual-based cognitive behavioural therapy within a framework of weekly sessions with a physician, physiotherapist or psychologist. One group receives solely TAU, serving as a control group, while the three remaining groups are active-treatment groups receiving add-on treatment with either mianserin, IRT or a combination of both.Treatment outcome is evaluated using self-administered rating scales, observer ratings and actigraph measurements at baseline, during treatment and post treatment. The primary outcome is subjective sleep quality using the Pittsburgh Sleep Quality Index. Secondary outcome measures are objective sleep length, nightmares, PTSD severity, symptoms of depression and anxiety, pain, quality of life and psychosocial functioning.DiscussionThis trial will be the first randomised controlled trial to examine sleep-enhancing treatment in trauma-affected refugees, as well as the first trial to investigate the effect of IRT and mianserin in this population. Therefore, this trial may optimise treatment recommendations for sleep disturbances in trauma-affected refugees. Based on our findings, we expect to discuss the effect of treatment, focussing on sleep disturbances. Furthermore, the results will provide new information regarding the association between sleep disturbances, PTSD symptoms, psychosocial functioning and quality of life in trauma-affected refugees.Trial registrationEudraCT registration under the name ‘Treatment of sleep disturbances in trauma-affected refugees – a randomised controlled trial’, registration number: 2015-004153-40, registered on 13 November 2015.ClinicalTrials.gov, ID: NCT02761161. Registered on 27 April 2016.
Highlights
Sleep disturbances are often referred to as a hallmark and as core symptoms of post-traumatic stress disorder (PTSD)
It is estimated that roughly 30% of the world’s refugees suffer from post-traumatic stress disorder (PTSD) and often of a more chronic form, compared to other populations suffering from PTSD [2,3,4]
Refugees are a heterogeneous group in terms of cultural background and country of origin, but share the experience of being forcibly displaced from their country of origin and in this matter differ from other groups being exposed to traumas, who continue to live under familiar and safe conditions [5]
Summary
Sleep disturbances are often referred to as a hallmark and as core symptoms of post-traumatic stress disorder (PTSD). It is estimated that roughly 30% of the world’s refugees suffer from post-traumatic stress disorder (PTSD) and often of a more chronic form, compared to other populations suffering from PTSD [2,3,4]. Refugees differ from populations with single or few traumatic experiences by often having experienced prolonged and repeated traumas pre-migration, during migration and continue to live under post-migration stressors, such as uncertainty about asylum status and temporary residence, concern about their families still unsafe in their home country, cultural and language difficulties, and perceived discrimination and racism [2, 3, 6]. Clinical guidelines for treatment, derived from research on other populations fail to account for the specific circumstances experienced by refugees, and cannot be assumed to apply to trauma-affected refugees in general [5,6,7]
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