Clinical trial NCT06246708: Cultural Adaptation of a Self-help App for Grieving Syrian Refugees in Switzerland
Official title: Cultural Adaptation of a Self-help App for Grieving Syrian Refugees in Switzerland. A Feasibility and Acceptability Pilot-RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bereavement
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Transfusion SRC
First posted: 2024-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot RCT with an intervention group and a wait-list control group
Primary purpose: OTHER

Brief summary: The goal of this pilot RCT is to investigate the acceptability and feasibility of an unguided culturally adapted self-help app for grieving Syrian refugees in Switzerland. Furthermore, the study will examine whether using the app has an effect on secondary outcomes (e.g., grief symptoms).The main questions it aims to answer are:

* Is the self-help app culturally acceptable and feasible in this target group and what do we need to adapt?
* Does the use of the self-help app reduce grief symptoms? (amongst other secondary outcomes)

Participants will be asked to:

* Complete a baseline assessment
* then use the self-help app for 5 weeks
* Complete a second assessment and participate in a short semi-structured interview regarding acceptability and feasibility.

Researchers will compare an intervention group to a wait-list control group to see if the use of the self-help app has an effect on secondary outcomes.

Detailed description: This study examines the acceptance and feasibility of an app designed to provide self-help information to grieving Syrian refugees in Switzerland. The app solely offers information and tips for self-help for grieving individuals. Its goal is not to provide psychological treatment and does not replace psychological assistance from a professional.

The app was developed in close collaboration with the Swiss Red Cross (SRC), potential users, and experts to tailor it to the needs of grieving Syrian refugees. The app is designed to serve as a supplementary module for the SRC's Sui app after the completion of this study.

Developed in the Arabic language, the app consists of five chapters, each with several subchapters. These chapters cover various information on grief and grief reactions, tips, audio exercises, case vignettes, explanatory videos, video testimonials, as well as written information on various topics such as resources, the importance of social relationships, and daily structure.

Apart from the ability to read, understand, and write in Arabic, familiarity with using a smartphone, and access to the internet, no special skills or conditions are required for using the app.

The self-help program is available as an app on common iOS and Android devices. The app does not include invasive components or medications. It only provides information and general recommendations for grieving individuals. Users can input data into the app, but the app merely stores this information. The app does not manipulate data with the entered information (e.g., it does not provide personalized recommendations or feedback based on user inputs).

In this study, we aim to determine the feasibility and acceptability of this app for grieving Syrian refugees. Additionally, we want to assess whether there are fewer grief symptoms after using the app. The results of the app will help us further tailor it to the needs of the users. To investigate this, we are recruiting 30 study participants who will be randomly assigned to one of two groups. One group will use the app for 5 weeks, while the other group will wait for 5 weeks before gaining access to the app. Both groups will complete questionnaires at two measurement points, with the first group also being asked to provide feedback on the app in a brief interview.

Eligibility criteria: Inclusion Criteria:

* Syrian refugees living in Switzerland
* Min. 18 years old
* Able to give informed consent as documented by signature
* Can read and understand, as well as write Arabic
* Possess a smartphone with access to the internet
* Have experienced the loss of a loved one due to death at least 3 months ago
* Severity score of at least 3 in at least one item of the IPGDS

Exclusion Criteria:

* Acute suicidality measured by self-report
* Lack of knowledge of Arabic language, both spoken and/or written

Primary outcomes:
measure: Intervention satisfaction
timeFrame: 5 weeks after baseline
measure: Evaluation of the process
timeFrame: 5 weeks after baseline
measure: Adherence
timeFrame: 5 weeks after baseline
Secondary outcomes:
measure: Grief severity
timeFrame: Baseline and 5 weeks after baseline
measure: Depression
timeFrame: Baseline and 5 weeks after baseline
measure: PTSD symptoms
timeFrame: Baseline and 5 weeks after baseline
measure: Anxiety
timeFrame: Baseline and 5 weeks after baseline
measure: Health and disability levels
timeFrame: Baseline and 5 weeks after baseline
measure: Psychological well being
timeFrame: Baseline and 5 weeks after baseline
Other outcomes:
measure: Life stressors of refugees
timeFrame: Baseline and 5 weeks after baseline
measure: Perceived social support
timeFrame: Baseline and 5 weeks after baseline
measure: Voluntary qualitative feedback to individual chapters
timeFrame: 5 weeks after baseline
measure: Socio-demographic information
timeFrame: Baseline
Locations:
city: Zürich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: University of Zurich
name: Myriam Thoma, PD Dr.
role: STUDY_CHAIR
affiliation: University of Zurich
name: Anaïs Aeschlimann, MSc
role: PRINCIPAL_INVESTIGATOR
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