Development and evaluation of a self-help app for traumatized Syrian refugees

Not Applicable

Recruiting

• Conditions: F43.1; F45.0; F30-F39; Post-traumatic stress disorder; Somatization disorder; Mood [affective] disorders

• Registration Number: DRKS00013782
• Lead Sponsor: Institut für Sozialmedizin, Arbeitsmedizin und Public Health (ISAP), Medizinische Fakultät, Universität Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

Syrian refguee, age between 18 and 65 years, owns a smartphone, written consent, screen positive for a trauma and at least mild to moderate posttraumatic stress symptoms (Posttraumatische Diagnoseskala/PDS5 = 11-59)

Exclusion Criteria

severe posttraumatic symptom severity (Posttraumatic Diagnostic Scale/PDS5 > 59), severe depressive symptomatology (Patient Health Questionnare/PHQ > 19), suicidal tendencies (Suicidality scale of the Depressive Symptomatology Index/SS-DIS > 2), pregnancy, in psychotherapy, psychotropic medication

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Posttraumatic stress (Posttraumatic Diagnostic Scale/PDS-5). Assessment schedule: T1: baseline (pre-intervention), T2: post-intervention (4 weeks after T1), T3: follow-up (16 weeks after T1)<br><br>

Secondary Outcome Measures

Name	Time	Method
Depressive symptomatology (Patient Health Questionnaire/PHQ-9), anxiety (General Anxiety Disorder/GAD-7), somatization (Patient Health Questionnaire/PHQ-15), general self-efficacy (General Self Efficacy Scale/GSE), posttraumatic growth (Posttraumatic Growth Inventory/PGI), social support (Experienced Social Support Inventory/ESSI) and social network (Lubben Social Network Scale/LSNS), self-stigmatization (Self-Stigma of Mental Illness Scale/SSMIS), ambiguous loss and complicated grief, quality of life (EuroQol Five Dimensions Questionnaire/EQ-5D-5L), direct health care costs (cost book), user acceptance (Technology Acceptance Model/TAM 3) and usability (System Usability Scale/SUS).<br><br>Assessment schedule: T1: baseline (pre-intervention), T2: post-intervention (4 weeks after T1), T3: follow-up (16 weeks after T1)