A self-help app for Syrian refugees with posttraumatic stress (Sanadak): results of a randomized controlled trial

Abstract

Abstract Background Syrian refugees often develop posttraumatic stress as a result of the Syrian civil war and migration stressors. However, there is a lack of adequate treatments. The smartphone app Sanadak was developed and evaluated to provide cognitive behavioral therapy-based self-help in the Arabic language for Syrian refugees with posttraumatic stress. Methods In a randomized controlled trial, eligible individuals were allocated to the intervention group (IG; app) or control group (CG; psychoeducational reading material). Data were collected during structured face-to-face interviews at 3 assessments (preintervention/baseline, postintervention/after 4 weeks, follow-up/after 4 months). Using adjusted mixed-effects models, changes in posttraumatic stress and secondary outcomes were investigated as intention-to-treat (ITT) and per-protocol (PP) analysis. Results Of 170 screened individuals (aged 18-65 years), 133 were eligible and randomized to the IG (n = 65) or CG (n = 68). Although there was a pre-post reduction in posttraumatic stress, ITT showed no significant differences between IG and CG after 4 weeks (Posttraumatic Diagnostic Scale for DSM-5, Diff -0.90, 95%CI -0.24 to 0.47; P=.52) and after 4 months (Diff -0.39, 95%CI -3.24 to 2.46; P=.79). The same was true for PP. Regarding secondary outcomes, ITT indicated a treatment effect for self-stigma after 4 weeks (Self-Stigma of Mental Illness Scale/SSMIS-stereotype agreement: d = 0.86, 95%CI 0.46 to 1.25; stereotype application: d = 0.60, 95%CI 0.22 to 0.99) and after 4 months (d = 0.52, 95%CI 0.12 to 0.92; d = 0.50, 95%CI 0.10 to 0.90). Conclusions Sanadak reduced mild to moderate posttraumatic stress in Syrian refugees, but not superior to the control condition. Therefore, Sanadak may not be suitable as a standalone treatment. However, as the app usability was very good, no harms detected, and stigma significantly reduced, Sanadak has potential as a bridging aid within a stepped and collaborative care approach.