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Cultural Adaptation of a Self-help App for Grieving Syrian Refugees in Switzerland

Cultural Adaptation of a Self-help App for Grieving Syrian Refugees in Switzerland. A Feasibility and Acceptability Pilot-RCT

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06246708
Enrollment
30
Registered
2024-02-07
Start date
2024-01-29
Completion date
2024-06-17
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bereavement

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.

Interventions

OTHERSelf-help app with information for grieving Syrian Refugees

This study explores a self-help app for grieving Syrian refugees in Switzerland, featuring five chapters on grief, resources, space, negative thoughts, and future self-help. The Arabic app includes psychoeducational content, audio exercises, and videos. Users personalize it, save favorites, and set reminders. Tailored for Arabic-speaking refugees, it's accessible on iOS and Android, without invasive components. Participants complete one weekly chapter over five weeks. Data input is stored without manipulation. Accessible data includes completed chapters, subchapters, and feedback. The app promotes self-help, respecting cultural nuances for user engagement.

Participants in the wait-list control group, receive access to the same intervention described above after a waiting period of 5 weeks.

Sponsors

Swiss Transfusion SRC
CollaboratorOTHER
University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Pilot RCT with an intervention group and a wait-list control group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intervention satisfaction5 weeks after baselineClient Satisfaction Questionnaire for Internet Interventions (CSQ-I). Items are rated from 1 to 4 (1= No' definitely not' 2= No' I don't think so' 3= Yes' I think so' 4=Yes' definitely), with higher scores indicating higher satisfaction.
Adherence5 weeks after baselineNumber of modules that a person has completed
Evaluation of the process5 weeks after baselineA short semi-structured interview was developed to assess the overall experience of the participants, the content of the intervention, the adherence to the intervention and the burden of the assessments.

Secondary

MeasureTime frameDescription
PTSD symptomsBaseline and 5 weeks after baselinePTSD Checklist 5 8- item Version (PCL-5). Responses are scored on a scale from 0 to 4 with higher scores indicating more pronounced symptom severity.
Grief severityBaseline and 5 weeks after baselineInternational ICD-11 Prolonged Grief Disorder Scale (IPGDS). Employs a 5-point scale: 1 = almost never (less than once a month), 2 = rarely (monthly), 3 = sometimes (weekly), 4 = often (daily), and 5 = always (several times a day), higher scores mean higher grief severity.
DepressionBaseline and 5 weeks after baselinePatient Health Questionnaire-9 Item (PHQ-9). Employs a scale ranging from 0 = never to 4 = practically every day. A higher score on the PHQ9 (range = 1 - 27) means a greater severity of depressive symptoms.
AnxietyBaseline and 5 weeks after baselineGeneralized Anxiety Disorder Screener (GAD-7). Employs a scale ranging from 0 = never to 4 = practically every day. A higher score on the GAD-7 (range = 0 - 21) means a greater severity of anxiety symptoms.
Health and disability levelsBaseline and 5 weeks after baselineWHO Disability Assessment Scale 2.0 (WHODAS 2.0). Items are answered on a 5-point scale ranging from 0 = none to 4 = extreme or cannot do.
Psychological well beingBaseline and 5 weeks after baselineWHO-5 Wellbeing Index (WHO-5). Items (e..g. I have felt cheerful and in good spirits) are rated from 0=at no time to 5=all the time.

Other

MeasureTime frameDescription
Perceived social supportBaseline and 5 weeks after baselineMultidimensional Scale of Perceived Social Support (MSPSS). Items are rated on a seven point scale (1 very strongly disagree to 7 very strongly agree), higher scores indicate higher perceived social support.
Life stressors of refugeesBaseline and 5 weeks after baselinePost Migration Living Difficulties Scale (PMLD; adapted to Swiss context). Items are rated on a five-point scale (0 not a problem to 4 very serious problem)
Socio-demographic informationBaselineSex, age, ethnicity, marital status, level of education, work situation, immigration status and time lived in Switzerland, loss-related characteristics such as the time of loss(es), the relationship to the deceased, the age and gender of lost person, cause of death, sudden or expected bereavement, ambiguous loss, information on whether currently undergoing psychotherapeutic treatment.
Voluntary qualitative feedback to individual chapters5 weeks after baselineParticipants will have the possibility to input feedback concerning the content of individual chapters of the app during the app usage phase. This will be done through the app by including an open question after each chapter (What feedback would you like to give us concerning the content of this previous chapter?)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026