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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Background Syrians represent the largest group among refugees in Germany. Many of them were exposed to sequential traumatizing events including war, escape and post-migration stressors, which significantly increase the risk to develop symptoms of posttraumatic stress and other mental disorders. However, there is a lack of adequate treatment options for traumatized refugees in Germany. Moreover, their access to psychosocial care is often restricted due to legal regulation, language barriers, and unclear cost coverage. We therefore aim to develop a low-threshold supportive self-help app for Syrian refugees with posttraumatic stress symptoms. By conducting a randomized controlled trial, we further aim to evaluate the apps’ efficacy, usability, acceptance, and economic health benefit/cost-effectiveness. Methods We will develop a modular, interactive self-help app in Arabic, which will be grounded on cognitive-behavioral models for the treatment of posttraumatic stress. Subsequently, screened positive (i.e., Syrian refugees, 18–65 years old, mild to moderate posttraumatic stress symptomatology as quantified by the Posttraumatic Stress Diagnostic Scale for DSM-5/PDS-5) participants (ideally up to n = 234) will be randomly allocated to an intervention (IG) and control group (CG), respectively. Participants in the IG will gain access to the self-help app for one month, while participants in the CG will receive psychoeducational reading material in form of a comprehensive brochure on traumatization and posttraumatic stress. Measurements are scheduled before the intervention (T0), directly after the intervention (T1, one month later) and three months after the intervention (T2). Using linear mixed effect models, we will investigate change in posttraumatic symptomatology. We will also test for changes in secondary outcomes such as depression, anxiety, and quality of life. Moreover, we will inspect the usability and user acceptance of the app. To evaluate the app in terms of its economic health benefit, the incremental cost-effectiveness ratio will be calculated. Discussion We plan to make the app freely available to the general public after evaluation. Thus, the app can help to add-on to routine care, which currently lacks sufficient and appropriate treatment options for Syrian refugees. Trial registration German Clinical Trials Register/Deutsches Register Klinischer Studien (DRKS). Registration ID: DRKS00013782 . Registered: 06th of July 2018.

Syria has been the main country of citizenship of refugees in Germany since 2013. Syrians face numerous human rights violations in their country that can be accompanied by the experience of potentially traumatic events, loss and displacement. Along the migration process, refugees are exposed to various factors that can have an impact on mental health. The aim of this study is to investigate sociodemographic, war- and flight-related as well as post-migration factors as predictors of posttraumatic stress, depression, somatization and anxiety in Syrian refugees with posttraumatic stress symptoms based in Germany. Data were based on the baseline sample of the “Sanadak” randomized-controlled trial. A total of 133 adult Syrian refugees participated in the study. A questionnaire covered sociodemographic and flight-related questions as well as standardized instruments for symptoms of PTSD (PDS-5), depression (PHQ-9), somatization (PHQ-15), anxiety (GAD-7), generalized self-efficacy (GSE), religiousness (Z-Scale), social support (ESSI) and mental health stigma (SSMIS-SF). Linear regression models were executed to predict mental health outcomes. Sociodemographic predictors (i.e., female sex, higher education) and flight-related predicting factors (i.e., variability of traumatic events) have a negative impact on mental health in Syrian refugees with posttraumatic stress symptoms in Germany. Mental health stigma predicts worse mental health outcomes. Post-migration factors have a major impact on mental health, such as low income, lack of social support, low life satisfaction or a strongly felt connection to Syria. Somatization is an important manifestation of mental distress in Syrian refugees with posttraumatic stress symptoms. Our study showed a range of factors predicting the mental health of Syrian refugees with posttraumatic stress symptoms. Measures to foster mental health could be securing financial security, promoting gender equality and tailored psychosocial programs addressing mental health stigma, loss and social support networks.

BackgroundApproximately 10% of the individuals experiencing the death of a loved one develop prolonged grief disorder (PGD) after bereavement. Family members of haematological cancer patients might be particularly burdened since their loss experience is preceded by a very strenuous time of disease and aggressive treatment. However, support needs of relatives of cancer patients often remain unmet, also after the death of the patient. Therapeutic possibilities are enhanced by providing easily available and accessible Internet-based therapies. This study will adapt and evaluate an Internet-based grief therapy for bereaved individuals after the loss of a significant other due to haematological cancer.MethodsThe efficacy of the Internet-based grief therapy is evaluated in a randomized controlled trial with a wait-list control group. Inclusion criteria are bereavement due to hematological cancer and meeting the diagnostic criteria for PGD. Exclusion criteria are severe depression, suicidality, dissociative tendency, psychosis, posttraumatic stress disorder, substance use disorder, and current psychotherapeutic or psychopharmacological treatment. The main outcome is PGD severity. Secondary outcomes are depression, anxiety, somatization, posttraumatic stress, quality of life, sleep quality, and posttraumatic growth. Data is collected pre- and posttreatment. Follow-up assessments will be conducted 3, 6, and 12 months after completion of the intervention. The Internet-based grief therapy is assumed to have at least moderate effects regarding PGD and other bereavement-related mental health outcomes. Predictors and moderators of the treatment outcome and PGD will be determined.DiscussionIndividuals bereaved due to haematological cancer are at high risk for psychological distress. Tailored treatment for this particularly burdened target group is missing. Our study results will contribute to a closing of this healthcare gap.Trial registrationGerman Clinical Trial Register UTN: U1111–1186-6255. Registered 1 December 2016.