@Article{info:doi/10.2196/24807,
author="R{\"o}hr, Susanne
and Jung, Franziska U
and Pabst, Alexander
and Grochtdreis, Thomas
and Dams, Judith
and Nagl, Michaela
and Renner, Anna
and Hoffmann, Rahel
and K{\"o}nig, Hans-Helmut
and Kersting, Anette
and Riedel-Heller, Steffi G",
title="A Self-Help App for Syrian Refugees With Posttraumatic Stress (Sanadak): Randomized Controlled Trial",
journal="JMIR Mhealth Uhealth",
year="2021",
month="Jan",
day="13",
volume="9",
number="1",
pages="e24807",
keywords="app; cost-utility analysis; mHealth; posttraumatic stress; PTSD; quality-adjusted life years; randomized controlled trial; refugees; stimga; Syrian refugees; usability",
abstract="Background: Syrian refugees residing in Germany often develop posttraumatic stress as a result of the Syrian civil war, their escape, and postmigration stressors. At the same time, there is a lack of adequate treatment options. The smartphone-based app Sanadak was developed to provide cognitive behavioral therapy--based self-help in the Arabic language for Syrian refugees with posttraumatic stress. Objective: The aim of this study was to evaluate the effectiveness and cost-effectiveness of the app. Methods: In a randomized controlled trial, eligible individuals were randomly allocated to the intervention group (IG; app use) 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 linear regression models, changes in posttraumatic stress and secondary outcomes were investigated as intention-to-treat (ITT) and per-protocol (PP) analysis. Cost-effectiveness was evaluated based on adjusted mean total costs, quality-adjusted life years (QALYs), and cost-effectiveness acceptability curves using the net benefit approach. Results: Of 170 screened individuals (aged 18 to 65 years), 133 were eligible and randomized to the IG (n=65) and CG (n=68). Although there was a pre-post reduction in posttraumatic stress, ITT showed no significant differences between the 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), the IG showed significantly lower values in self-stigma than the CG. ITT showed no significant group differences in total costs and QALYs. The probability of cost-effectiveness was 81{\%} for a willingness-to-pay of {\texteuro}0 per additional QALY but decreased with increasing willingness-to-pay. Conclusions: Sanadak was not more effective in reducing mild to moderate posttraumatic stress in Syrian refugees than the control condition nor was it likely to be cost-effective. Therefore, Sanadak is not 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. Trial Registration: German Clinical Trials Register DRKS00013782; https://www.drks.de/drks{\_}web/navigate.do?navigationId=trial.HTML{\&}TRIAL{\_}ID=DRKS00013782 International Registered Report Identifier (IRRID): RR2-10.1186/s12888-019-2110-y ",
issn="2291-5222",
doi="10.2196/24807",
url="http://mhealth.jmir.org/2021/1/e24807/",
url="https://doi.org/10.2196/24807",
url="http://www.ncbi.nlm.nih.gov/pubmed/33439140"
}