DOI: 10.6084/m9.figshare.28380854.v1
title: Treating sleep disturbances in refugees and asylum seekers: results from a randomized controlled pilot trial evaluating the STARS group intervention

description: <b>Background:</b> Sleep disturbances are highly prevalent in traumatized refugees and often persist despite treatment, and adapted scalable interventions are needed. The group intervention ‘Sleep Training adapted for Refugees’ (STARS) is a culturally- and context-sensitive approach based on evidence-based treatments for sleep disturbances (e.g. CBT-I, IRT). This study evaluated the feasibility, acceptability, and effectiveness of STARS. <b>Method:</b> A randomized-controlled trial (STARS vs. waitlist) with 47 young male Afghan refugees was conducted in a routine clinical setting (DRKS-ID: DRKS00024419) with pre-, post- and 3-month follow-up assessments. The primary outcome was insomnia severity (Insomnia Severity Index); secondary outcomes included PTSD, anxiety and depression symptoms, nightmares, coping with nightmares, fear of sleep, selected sleep diary measures, and quality of life. The data were analysed using mixed models. <b>Results:</b> Adherence to STARS was high (dropout = 17.4%, average attended sessions = 77%) as was client satisfaction (<i>M</i><sub>CSQ-4</sub><i> </i>= 12.74, <i>SD</i><sub>CSQ-4</sub><i> </i>= 2.08). A medium to large significant effect of time was observed for insomnia severity (<i>d</i> = 0.96) and most secondary measures (except nightmares and fear of sleep). However, there was no significant interaction with condition at post-treatment for the primary outcome (<i>d</i> = 0.29) and most secondary outcomes; the only exceptions were increased coping with nightmares, decreased daytime sleep, and time in bed. <b>Conclusions:</b> STARS appears feasible for treating sleep disturbances in traumatized refugees in a routine clinical setting, showing moderate to large within-group effects. However, it was not superior to the waitlist, likely due to unexpected improvements in the waitlist group. Adjustments to STARS may enhance its efficacy. Further research is needed to determine how STARS can be a scalable add-on treatment for sleep disturbances in traumatized refugees and asylum seekers. <b>Trial registration:</b>German Clinical Trials Register identifier: DRKS00024419.. A context- and culture-sensitive group sleep intervention for traumatized refugees and asylum-seekers was feasible in a routine clinical setting.Client satisfaction and acceptance were high, indicating successful adaptation of evidence-based sleep interventions.Insomnia severity and most secondary outcomes were significantly reduced post-treatment and at follow-up, yet no superiority to waitlist was found.Further research is needed to refine STARS and explore scalable, effective treatments for sleep disturbances in this population. A context- and culture-sensitive group sleep intervention for traumatized refugees and asylum-seekers was feasible in a routine clinical setting. Client satisfaction and acceptance were high, indicating successful adaptation of evidence-based sleep interventions. Insomnia severity and most secondary outcomes were significantly reduced post-treatment and at follow-up, yet no superiority to waitlist was found. Further research is needed to refine STARS and explore scalable, effective treatments for sleep disturbances in this population.