Bereavement Clinical Trial
Official title:
Cultural Adaptation of a Self-help App for Grieving Syrian Refugees in Switzerland. A Feasibility and Acceptability Pilot-RCT
NCT number | NCT06246708 |
Other study ID # | IBISYR |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 29, 2024 |
Est. completion date | June 1, 2024 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University of Zurich | Zürich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | Swiss Transfusion SRC |
Switzerland,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Life stressors of refugees | Post 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) | Baseline and 5 weeks after baseline | |
Other | Perceived social support | Multidimensional 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. | Baseline and 5 weeks after baseline | |
Other | Voluntary qualitative feedback to individual chapters | Participants 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?") | 5 weeks after baseline | |
Other | Socio-demographic information | Sex, 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. | Baseline | |
Primary | 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 | |
Primary | 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 | |
Primary | Adherence | Number of modules that a person has completed | 5 weeks after baseline | |
Secondary | 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. | Baseline and 5 weeks after baseline | |
Secondary | 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. | Baseline and 5 weeks after baseline | |
Secondary | 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. | Baseline and 5 weeks after baseline | |
Secondary | 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. | Baseline and 5 weeks after baseline | |
Secondary | 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". | Baseline and 5 weeks after baseline | |
Secondary | 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". | Baseline and 5 weeks after baseline |
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