Treating sleep disturbances in refugees and asylum seekers: results from a randomized controlled pilot trial evaluating the STARS group intervention.

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. 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. Adherence to STARS was high (dropout = 17.4%, average attended sessions = 77%) as was client satisfaction (= 12.74, = 2.08). A medium to large significant effect of time was observed for insomnia severity ( = 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 ( = 0.29) and most secondary outcomes; the only exceptions were increased coping with nightmares, decreased daytime sleep, and time in bed. 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. German Clinical Trials Register identifier: DRKS00024419..