Trial document




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  DRKS00013782

Trial Description

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Title

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

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Trial Acronym

HELP@APP

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URL of the Trial

http://isap.uniklinikum-leipzig.de/isap.site,postext,ag-public-health,a_id,270.html

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Brief Summary in Lay Language

Syrians are the largest group among refugees in Germany. Since the worsening of the situation in Syria due the civil war in 2015, more than 470,000 Syrians have sought asylum in Germany. Many of the refugees have been traumatized by war-related experiences, such as violence or torture, and/or by the fleeing itself. Additionally, refugees have to deal with complex demands in the country of asylum which strongly differs in terms of culture. The research project HELP@APP aims at developing an interactive self-help app for traumatized Syrian refugees to help to cope with posttraumatic stress. The app has a modular setup. Key elements include coping with mental problems and handling of trauma-related triggers, based on established methods of cognitive-behavioral therapy. Moreover, the app should be helpful in seeking social support, and in learning activities for relaxation. The app also contains varying self-tests which, depending on the answers, will lead to an automated individualized feedback. After the app has been developed, a study with Syrian refugees will be performed to evaluate the efficacy and cost-efficacy of the app. To do so, Syrian refugees will be screened for inclusion and exclusion criteria and, if found suitable for study participation, will be given access to the app. For comparison, a control group will receive a psychoeducational information brochure on traumatization. Likewise, the usability and user acceptance of the app will be evaluated. If proven effective, the app will be made freely available.

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Brief Summary in Scientific Language

First, development of a smartphone-based interactive self-help app in Arabic language for traumatized Syrian refugees in Germany, based on established principles of cognitive-behavioral therapy (CBT). Second, evaluation of the efficacy and cost-efficacy of the app in form of a randomized-controlled trial (RCT) with two legs: intervention group (IG, use of the app for four weeks) and an active control group (CG, receive a psychoeducational information brochure on traumatization). After an initial screening to control the inclusion and exclusion criteria, stratified block randmoization will be used to randomly assign study participants to either IG or CG. Three assessments will take place: baseline (pre-intervention), directly at the end of the intervention (post-intervention; four weeks after baseline), and three months after baseline (follow-up). Primary (i.e., posttraumatic stress) and secondary (i.e., for example, depressive symptomatology, quality of life) outcomes will be assessed to investigate change between baseline and post-intervention and follow-up between the study groups, applying descriptive statistics as well as growth curve modes. If found to be effective, the app will be made freely available.

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Organizational Data

  •   DRKS00013782
  •   2018/07/06
  •   [---]*
  •   yes
  •   Approved
  •   111/17-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F43.1 -  Post-traumatic stress disorder
  •   F45.0 -  Somatization disorder
  •   F30-F39 -  Mood [affective] disorders
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Interventions/Observational Groups

  •   intervention group: use of the smartphone-based app over four weeks.
  •   active control group: receive a psychoeducational Information brochure on traumatization/posttraumatic stress
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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)

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Secondary Outcome

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).

Assessment schedule: T1: baseline (pre-intervention), T2: post-intervention (4 weeks after T1), T3: follow-up (16 weeks after T1)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2018/11/15
  •   234
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional 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)

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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

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Addresses

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    • Institut für Sozialmedizin, Arbeitsmedizin und Public Health (ISAP), Medizinische Fakultät, Universität Leipzig
    • Ms.  Prof. Dr.  Steffi  Riedel-Heller 
    • Philipp-Rosenthal-Straße 55
    • 04103  Leipzig
    • Germany
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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Medizinische Fakultät, Universität Leipzig
    • Ms.  Prof. Dr. med.  Anette  Kersting 
    • Semmelweisstraße 10
    • 04103  Leipzig
    • Germany
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    • Institut für Gesundheitsökonomie und Versorgungsforschung, Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Prof. Dr. med.  Hans-Helmut  König 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • AOK-Bundesverband
    • Rosenthaler Straße 31
    • 10178  Berlin
    • Germany
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    •   030346462651
    •   03034646332651
    •   [---]*
    •   [---]*
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    • Institut für Sozialmedizin, Arbeitsmedizin und Public Health (ISAP), Medizinische Fakultät, Universität Leipzig
    • Ms.  Prof. Dr.  Steffi  Riedel-Heller 
    • Philipp-Rosenthal-Straße 55
    • 04103  Leipzig
    • Germany
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    • Institut für Sozialmedizin, Arbeitsmedizin und Public Health (ISAP), Medizinische Fakultät, Universität Leipzig
    • Ms.  Dr.  Susanne  Röhr 
    • Philipp-Rosenthal-Straße 55
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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