Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Oct 6, 2020
Date Accepted: Nov 3, 2020
A Self-help App for Syrian Refugees with Posttraumatic Stress: Results of the “Sanadak” Randomized Controlled Trial
ABSTRACT
Background:
Syrian refugees residing in Germany often develop posttraumatic stress as a result of the Syrian civil war, their escape and post-migration 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 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 usage) or control group (CG; psychoeducational reading material). Data were collected during structured face-to-face interviews at three assessments (pre-intervention/baseline, post-intervention/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 evluated 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 (18-65 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/PDS-5, Diff = 0.90, 95% confidence interval/CI = 0.24-0.47, P = .52) and after 4 months (Diff = 0.39, 95%CI = 3.24-2.46, 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 = 0.46-1.25; stereotype application: d = 0.60, 95%CI = 0.22-0.99) and after 4 months (d = 0.52, 95%CI = 0.12-0.92; d = 0.50, 95%CI = 0.10-0.90), 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. Clinical Trial: German Clinical Trials Register/Deutsches Register Klinischer Studien (DRKS; registration ID: DRKS00013782). Link: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013782
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