HELP@APP: development and evaluation of a self-help app for traumatized Syrian refugees in Germany - a study protocol of a randomized controlled trial.
Adolescent
Adult
Aged
Cognitive Behavioral Therapy
/ economics
Cost-Benefit Analysis
/ statistics & numerical data
Female
Germany
Humans
Male
Middle Aged
Mobile Applications
Patient Acceptance of Health Care
/ psychology
Quality of Life
/ psychology
Refugees
/ psychology
Research Design
Self Care
/ methods
Stress Disorders, Post-Traumatic
/ psychology
Syria
/ ethnology
Treatment Outcome
Young Adult
App
Digital health
Intervention
Posttraumatic stress
RCT
Refugee
Self-management program
Syria
Trauma
Traumatization
mHealth
Journal
BMC psychiatry
ISSN: 1471-244X
Titre abrégé: BMC Psychiatry
Pays: England
ID NLM: 100968559
Informations de publication
Date de publication:
30 04 2019
30 04 2019
Historique:
received:
25
01
2019
accepted:
10
04
2019
entrez:
2
5
2019
pubmed:
2
5
2019
medline:
28
1
2020
Statut:
epublish
Résumé
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.
Sections du résumé
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.
Identifiants
pubmed: 31039786
doi: 10.1186/s12888-019-2110-y
pii: 10.1186/s12888-019-2110-y
pmc: PMC6492415
doi:
Banques de données
DRKS
['DRKS00013782']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
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