Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, Philipp-Rosenthal-Straße 55, 04103, Leipzig, Germany.
Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
BMC Psychiatry. 2019 Apr 30;19(1):131. doi: 10.1186/s12888-019-2110-y.
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.
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.
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.
German Clinical Trials Register/Deutsches Register Klinischer Studien (DRKS). Registration ID: DRKS00013782 . Registered: 06th of July 2018.
叙利亚人是德国难民中最大的群体。他们中的许多人都经历了连续的创伤性事件，包括战争、逃亡和后迁移压力源，这大大增加了出现创伤后应激症状和其他精神障碍的风险。然而，德国针对创伤难民的治疗选择非常有限。此外，由于法律规定、语言障碍和费用覆盖范围不明确，他们获得心理社会护理的机会往往受到限制。因此，我们旨在为患有创伤后应激症状的叙利亚难民开发一个低门槛的支持性自助应用程序。通过进行随机对照试验，我们还旨在评估该应用程序的疗效、可用性、可接受性和经济健康效益/成本效益。
我们将用阿拉伯语开发一个模块化、互动式的自助应用程序，该程序将基于认知行为模型来治疗创伤后应激。随后，筛选出阳性（即 18-65 岁的叙利亚难民，创伤后应激症状量表第五版（PDS-5）轻度至中度创伤后应激症状）的参与者（理想情况下最多 234 名）将被随机分配到干预组（IG）和对照组（CG）。IG 组的参与者将在一个月内使用自助应用程序，而 CG 组的参与者将获得创伤和创伤后应激的综合小册子形式的心理教育阅读材料。测量时间安排在干预前（T0）、干预后直接（T1，一个月后）和干预后三个月（T2）。我们将使用线性混合效应模型来研究创伤后症状的变化。我们还将测试抑郁、焦虑和生活质量等次要结果的变化。此外，我们还将检查应用程序的可用性和用户接受程度。为了评估应用程序的经济效益，将计算增量成本效益比。
我们计划在评估后将应用程序免费提供给公众。因此，该应用程序可以帮助补充常规护理，目前常规护理缺乏针对叙利亚难民的足够和适当的治疗选择。
德国临床试验注册处/德国临床试验注册处（DRKS）。注册号：DRKS00013782。注册日期：2018 年 7 月 6 日。
