A Self-Help App for Syrian Refugees With Posttraumatic Stress (Sanadak): Randomized Controlled Trial
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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 €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.
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For Syrian refugees, studies on digital interventions find effects ranging from small, nonsignificant to medium on mental health outcomes.
“For Syrian refugees, there is only a small number of studies on digital interventions that find a range from small, nonsignificant effects [21,22] to medium effects [23] on mental health outcomes.”
From Effects of a self-guided digital mental health self-help intervention for Syrian refugees in Egypt: A pragmatic randomized controlled trial (2024) · cites this paper as [21]
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- Authors
- Röhr, S., Jung, F. U., Pabst, A., Grochtdreis, T., Dams, J., Nagl, M., Renner, A., Hoffmann, R., König, H.-H., Kersting, A., & Riedel-Heller, S. G.
- Affiliations
- Trinity College Dublin (IE)
- Leipzig University (DE)
- University Medical Center Hamburg-Eppendorf (DE)
- University Hospital Leipzig (DE)
- Corresponding author
- Röhr, Susanne
- ORCID
- Venue
- JMIR mhealth and uhealth
- Publisher
- JMIR Publications Inc.
- Published
- 2021-01-13
- Volume
- 9
- Issue
- 1
- Pages
- e24807
- ISSN
- 2291-5222 (ISSN-L)
- PMC
- PMC7935251
- OpenAlex
- W3120594701
- Cited by
- 92
- References
- 53
- Citations by year
- 2026: 9 · 2025: 22 · 2024: 13 · 2023: 17 · 2022: 25 · 2021: 6
- FWCI
- 10.40
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- JMIR mhealth and uhealth (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Posttraumatic Stress Disorder Research
- Social Sciences › Psychology › Clinical Psychology › Migration, Health and Trauma
- Social Sciences › Sociology and Political Science › Migration and Exile Studies
- Keywords
- post-traumatic stress disorder, Syrian refugees, mobile health apps, cognitive behavioral therapy, self-help intervention, self-stigma, cost-effectiveness, quality-adjusted life years, refugee mental health, psychoeducation, Germany, medication adherence, quality of life, anxiety, sleep disorders, post-traumatic stress
- MeSH terms
- Adolescent, Adult, Aged, Germany, Humans, Middle Aged, Refugees, Stress Disorders, Post-Traumatic, Syria, Young Adult, Mobile Applications
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