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

NCT06246708 | Completed DMC

• 1 other identifier: IBISYR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bereavement

Outcome Measures

Primary Outcomes (3)

• Intervention satisfaction

  Client 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.

  5 weeks after baseline

• Evaluation of the process

  A 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.

  5 weeks after baseline

• Adherence

  Number of modules that a person has completed

  5 weeks after baseline

Secondary Outcomes (6)

• Grief severity

  Baseline and 5 weeks after baseline

• Depression

  Baseline and 5 weeks after baseline

• PTSD symptoms

  Baseline and 5 weeks after baseline

• Anxiety

  Baseline and 5 weeks after baseline

• Health and disability levels

  Baseline and 5 weeks after baseline

Other Outcomes (4)

• Life stressors of refugees

  Baseline and 5 weeks after baseline

• Perceived social support

  Baseline and 5 weeks after baseline

• Voluntary qualitative feedback to individual chapters

  5 weeks after baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants receive intervention at baseline for 5 weeks

Other: Self-help app with information for grieving Syrian Refugees

Wait-list Control Group

OTHER

Participants receive the intervention after 5 weeks

Other: Wait-list

Interventions

Self-help app with information for grieving Syrian Refugees OTHER

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.

Intervention Group

Wait-list OTHER

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

Wait-list Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead
• Swiss Transfusion SRC: collaborator

Study Sites (1)

University of Zurich

Zurich, 8050, Switzerland

Location

Related Publications (10)

• Bech P, Olsen LR, Kjoller M, Rasmussen NK. Measuring well-being rather than the absence of distress symptoms: a comparison of the SF-36 Mental Health subscale and the WHO-Five Well-Being Scale. Int J Methods Psychiatr Res. 2003;12(2):85-91. doi: 10.1002/mpr.145.

  PMID: 12830302 BACKGROUND

• Boss L, Lehr D, Reis D, Vis C, Riper H, Berking M, Ebert DD. Reliability and Validity of Assessing User Satisfaction With Web-Based Health Interventions. J Med Internet Res. 2016 Aug 31;18(8):e234. doi: 10.2196/jmir.5952.

  PMID: 27582341 BACKGROUND

• Killikelly C, Zhou N, Merzhvynska M, Stelzer EM, Dotschung T, Rohner S, Sun LH, Maercker A. Development of the international prolonged grief disorder scale for the ICD-11: Measurement of core symptoms and culture items adapted for chinese and german-speaking samples. J Affect Disord. 2020 Dec 1;277:568-576. doi: 10.1016/j.jad.2020.08.057. Epub 2020 Aug 27.

  PMID: 32896722 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Lowe B, Kroenke K, Herzog W, Grafe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004 Jul;81(1):61-6. doi: 10.1016/S0165-0327(03)00198-8.

  PMID: 15183601 BACKGROUND

• Price M, Szafranski DD, van Stolk-Cooke K, Gros DF. Investigation of abbreviated 4 and 8 item versions of the PTSD Checklist 5. Psychiatry Res. 2016 May 30;239:124-30. doi: 10.1016/j.psychres.2016.03.014. Epub 2016 Mar 8.

  PMID: 27137973 BACKGROUND

• Schick M, Zumwald A, Knopfli B, Nickerson A, Bryant RA, Schnyder U, Muller J, Morina N. Challenging future, challenging past: the relationship of social integration and psychological impairment in traumatized refugees. Eur J Psychotraumatol. 2016 Feb 12;7:28057. doi: 10.3402/ejpt.v7.28057. eCollection 2016.

  PMID: 26886484 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Üstün, T., Kostanjsek, N., Chatterji, S., & Rehm, J. (Hrsg.). (2010). Measuring health and disability: Manual for WHO Disability Assessment Schedule WHODAS 2.0. World Health Organization.

  BACKGROUND

• Zimet, G., Dahlem, N., Zimet, S., & Farley, G. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52(1), 30-41. https://doi.org/10.1207/s15327752jpa5201_2

  BACKGROUND

MeSH Terms

Interventions

Waiting Lists

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Myriam Thoma, PD Dr.

  University of Zurich

  STUDY CHAIR

• Anaïs Aeschlimann, MSc

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 7, 2024
• Study Start: January 29, 2024
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)