HELP@APP: development and evaluation of a self-help app for traumatized Syrian refugees in Germany – a study protocol of a randomized controlled trial

Abstract

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.

Recruitment and Baseline Characteristics of Participants in the “Sanadak” Trial: A Self-Help App for Syrian Refugees with Post-traumatic Stress

“…Individuals who signaled interest in taking part in the study were screened to assess eligibility for trial participation with regard to post-traumatic stress symptom severity, symptoms of depression, and suicidal risk in accordance with the study protocol [ 13 ]. Inclusion criteria were: Syrian refugee living in Germany, aged 18–65 years, the experience of at least one traumatic event and subsequent mild to moderate post-traumatic stress symptom severity (Posttraumatic Diagnostic Scale for DSM-5, PDS-5 = 11–59 [ 15 ]) and owning a compatible device in order to be able to use the app (Android/iOS).…”

“…After the screening, eligible individuals, who agreed to take part in the trial, underwent an additional comprehensive assessment on psychosocial health and associated factors (baseline assessment), including, among others, measures on generalized anxiety (GAD-7, [ 21 ]), severity of somatic symptoms (PHQ-15, [ 22 ]), general self-efficacy (GSE, [ 23 ]); self-stigma (Self-stigma of Mental Illness Scale–Short Form, SSMIS-SF, [ 24 ]); social support (short form of the Lubben Social Network Scale, LSNS-6, [ 25 ]; ENRICHD Social Support Inventory, ESSI, [ 26 ]); and health-related quality of life and health status (5-level version of EQ-5D and EQVAS, EQ-5D-5L, [ 27 ]). Please see the aforementioned study protocol for further information [ 13 ].…”

“…The effectiveness of the app is evaluated in a randomized-controlled trial (RCT) with two arms: the intervention group uses the app and the control group receives psychoeducational reading material in order to increase knowledge and awareness of PTSD. Details have been described elsewhere [ 13 ].…”

A mobile app implementing the international classification of functioning, disability and health rehabilitation set

“…A mobile app could facilitate more frequent assessment, allow more objective data collection, save storage space, prevent data loss, and ensure high-speed data delivery [13][14][15]. It can be used flexibly even without Internet access, making health information available without cite restriction [16]. Mobile health apps have been shown to improve efficiency and value while lowering costs [17].…”

Strategien zur Rekrutierung von Geflüchteten für Interventionsstudien: Erkenntnisse aus dem „Sanadak“-Trial

“…Dafür werden n = 122 Studienteilnehmer im Alter zwischen 18 und 65 Jahren an den Standorten Leipzig, Dresden und Halle/Saale zwischen Oktober 2018 und Dezember 2019 rekrutiert. Vollständige Informationen zum Trial sind dem publizierten Studienprotokoll zu entnehmen [6].…”