drugset / Trial / NCT02761161
Treatment of Sleep Disturbances in Trauma-affected Refugees
Phase 4
Completed
241 enrolled
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Danish Center for Sleep Medicine · collab
RandomizedFactorialOpen-labelTreatment
Summary
The overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with PTSD.
Timeline
- Start
- 2016-03
- Primary completion
- 2019-06-01
- Completion
- 2019-06-01
Publications
- Carlsson J, Bruhn M, Poschmann IS, Silove D, Westergaard ML, Mortensen EL, Sandahl H. Identifying robust predictors of treatment response in trauma-affected refugees: Results from a randomised controlled trial. PLoS One. 2025 Sep 26;20(9):e0324935. doi: 10.1371/journal.pone.0324935. eCollection 2025.
- Sandahl H, Korshoj M, Mortensen OS, Carlsson J. Increase in physical activity is associated with an increase in sleep efficiency, but not with improvement in symptoms of PTSD: analysis of longitudinal data in trauma-affected refugees. J Act Sedentary Sleep Behav. 2024 Feb 15;3(1):7. doi: 10.1186/s44167-024-00046-8.
- Asah C, Sandahl H, Baandrup L, Carlsson J, Jennum P. Dream Enactment Behaviour in Post-Traumatic Stress Disorder. Eur J Psychotraumatol. 2025 Dec;16(1):2444743. doi: 10.1080/20008066.2024.2444743. Epub 2025 Jan 7.
- Sandahl H, Baandrup L, Vindbjerg E, Jennum P, Carlsson J. Social zeitgebers and circadian dysrhythmia are associated with severity of symptoms of PTSD and depression in trauma-affected refugees. Eur Arch Psychiatry Clin Neurosci. 2021 Oct;271(7):1319-1329. doi: 10.1007/s00406-021-01266-8. Epub 2021 May 6.
- Sandahl H, Carlsson J, Sonne C, Mortensen EL, Jennum P, Baandrup L. Investigating the link between subjective sleep quality, symptoms of PTSD, and level of functioning in a sample of trauma-affected refugees. Sleep. 2021 Sep 13;44(9):zsab063. doi: 10.1093/sleep/zsab063.
- Sandahl H, Jennum P, Baandrup L, Poschmann IS, Carlsson J. Treatment of sleep disturbances in trauma-affected refugees: Study protocol for a randomised controlled trial. Trials. 2017 Nov 6;18(1):520. doi: 10.1186/s13063-017-2260-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mianserin | Small molecule | 30 mg | — |