A Self-Help App for Syrian Refugees With Posttraumatic Stress (Sanadak): Randomized Controlled Trial (Preprint)

03 medical and health sciences 0302 clinical medicine 3. Good health
DOI: 10.2196/preprints.24807 Publication Date: 2021-01-13T15:49:01Z
ABSTRACT
<sec> <title>BACKGROUND</title> Syrian refugees residing in Germany often develop posttraumatic stress as a result of the civil war, their escape, and postmigration stressors. At same time, there is lack adequate treatment options. The smartphone-based app Sanadak was developed to provide cognitive behavioral therapy–based self-help Arabic language for with stress. </sec> <title>OBJECTIVE</title> aim this study evaluate effectiveness cost-effectiveness app. <title>METHODS</title> In randomized controlled trial, eligible individuals were randomly allocated intervention group (IG; use) or control (CG; psychoeducational reading material). Data collected during structured face-to-face interviews at 3 assessments (preintervention/baseline, postintervention/after 4 weeks, follow-up/after months). Using adjusted mixed-effects linear regression models, changes secondary outcomes investigated intention-to-treat (ITT) per-protocol (PP) analysis. Cost-effectiveness evaluated based on mean total costs, quality-adjusted life years (QALYs), acceptability curves using net benefit approach. <title>RESULTS</title> Of 170 screened (aged 18 65 years), 133 IG (n=65) CG (n=68). Although pre-post reduction stress, ITT showed no significant differences between after weeks (Posttraumatic Diagnostic Scale DSM-5, Diff –0.90, 95% CI –0.24 0.47; &lt;i&gt;P&lt;/i&gt;=.52) months (Diff –0.39, –3.24 2.46; &lt;i&gt;P&lt;/i&gt;=.79). true PP. Regarding outcomes, indicated effect self-stigma: (Self-Stigma Mental Illness Scale/SSMIS–stereotype agreement: &lt;i&gt;d&lt;/i&gt;=0.86, 0.46 1.25; stereotype application: &lt;i&gt;d&lt;/i&gt;=0.60, 0.22 0.99) (&lt;i&gt;d&lt;/i&gt;=0.52, 0.12 0.92; &lt;i&gt;d&lt;/i&gt;=0.50, 0.10 0.90), significantly lower values self-stigma than CG. costs QALYs. probability 81% willingness-to-pay €0 per additional QALY but decreased increasing willingness-to-pay. <title>CONCLUSIONS</title> not more effective reducing mild moderate condition nor it likely be cost-effective. Therefore, suitable standalone treatment. However, usability very good, harms detected, stigma reduced, has potential bridging aid within stepped collaborative care <title>CLINICALTRIAL</title> German Clinical Trials Register DRKS00013782; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&amp;amp;TRIAL_ID=DRKS00013782 <title>INTERNATIONAL REGISTERED REPORT</title> RR2-10.1186/s12888-019-2110-y
SUPPLEMENTAL MATERIAL
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