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BereavementNCT06246708

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

A study testing Self-help app with information for grieving Syrian Refugees and Wait-list in people with Bereavement, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bereavement
What is being tested?
Self-help app with information for grieving Syrian Refugees and Wait-list
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSwitzerland
Study dates
29 Jan 2024to 17 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University of Zurich

    Zurich, 8050

Other trials in Switzerland

About this study

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

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)
Read more

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.

Read the 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.

Conditions
Bereavement
Being tested
Self-help app with information for grieving Syrian Refugees, Wait-list

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-help app with information for grieving Syrian RefugeesOther

    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.

  • Wait-listOther

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

Study groups in NCT06246708
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants receive intervention at baseline for 5 weeks
Receives: Other: Self-help app with information for grieving Syrian Refugees
Wait-list Control GroupOtherParticipants receive the intervention after 5 weeks
Receives: Other: Wait-list

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 weeks after baseline

  2. 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.

    Measured: 5 weeks after baseline

  3. Adherence

    Number of modules that a person has completed

    Measured: 5 weeks after baseline

Secondary outcomes (6)

  1. Grief severity

    International 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.

    Measured: Baseline and 5 weeks after baseline

  2. Depression

    Patient 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.

    Measured: Baseline and 5 weeks after baseline

  3. PTSD symptoms

    PTSD 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.

    Measured: Baseline and 5 weeks after baseline

  4. Anxiety

    Generalized 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.

    Measured: Baseline and 5 weeks after baseline

  5. Health and disability levels

    WHO 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".

    Measured: Baseline and 5 weeks after baseline

  6. Psychological well being

    WHO-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".

    Measured: Baseline and 5 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2024
  2. Study start29 Jan 2024
  3. Primary completion17 Jun 2024
  4. Study completion17 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pilot RCT with an intervention group and a wait-list control group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06246708
Sponsor's protocol ID
IBISYR
Status last verified
Aug 2024
First submitted
19 Jan 2024
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12830302

  • 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.

    PubMed 27582341

  • 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.

    PubMed 32896722

  • 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.

    PubMed 11556941

  • 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.

    PubMed 15183601

  • 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.

    PubMed 27137973

  • 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.

    PubMed 26886484

  • 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.

    PubMed 16717171

  • 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.

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Self-help app with information for grieving Syrian Refugees and Wait-list in people with Bereavement, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention satisfaction (time frame: 5 weeks after baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06246708, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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