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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05651737
Other study ID # 2022-00607
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2022
Est. completion date March 27, 2024

Study information

Verified date May 2024
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The ongoing warfare and economic instability in the Middle East and in North Africa causes many people to leave their home countries. Arrived in a host countries, in this example, in Switzerland, they face a lot of structural and psychosocial hurdles. Particularly in the first years, building up a certain quality of life is complicated and challenging. To support this process, the Swiss Red Cross and the University of Bern have developed the Sui app. It contains structural and social information as well as low-intensity psychological tools to provide support to the everyday life of Arabic-speaking people in Switzerland.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date March 27, 2024
Est. primary completion date March 27, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least 18 years old - Arabic as native or second language - Good knowledge of reading, writing and speaking Arabic - Have lived in Switzerland for no longer than 5 years - Give written consent - Have access to a smartphone and an internet connection - Indicate an emergency contact whom they could contact in event of a crisis Exclusion Criteria: - Indicate an increased risk of self-harm or suicide at baseline - Indicate having been diagnosed with psychosis or bipolar disorder - Be participating in a similar study at baseline - Have a lack of written and spoken Arabic skills

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sui App (SRK)
The Sui app contains the following chapters: 6 well-being chapters on: stress, sleep, resources throughout the day, chronic pain, emotion regulation, audio exercises 9 Swiss-specific information chapters on: housing, health (two sub-chapters), finances, asylum process, residence status, social integration, occupational integration, family reunification

Locations

Country Name City State
Switzerland University of Bern Bern BE

Sponsors (3)

Lead Sponsor Collaborator
University of Bern Freie Universität Berlin, Swiss Transfusion SRC

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Well-being at baseline Measured by the WHO Quality of Life Short Version (WHOQOL-BREF, 4 domain scores, mean score multiplied by 4, 0 (low) to 100 (high) range) Baseline
Primary Well-being at post-intervention timepoint Measured by the WHO Quality of Life Short Version (WHOQOL-BREF, 4 domain scores, mean score multiplied by 4, 0 (low) to 100 (high) range) Post (after 8 weeks)
Primary Well-being at follow-up timepoint Measured by the WHO Quality of Life Short Version (WHOQOL-BREF, 4 domain scores, mean score multiplied by 4, 0 (low) to100 (high) range) Follow-Up (after 16 weeks)
Secondary Satisfaction with the treatment Measured by the Questionnaire on satisfaction with the treatment (ZUF-8, 1(low) to 4 (high) scores) adapted for "app" as intervention Post (after 8 weeks), Follow-Up (after 16 weeks)
Secondary Self-stigma Measured by the Self-stigma of mental illness scale short form (SSMIS-SF, 1(strongly disagree) to 9 (strongly agree) scores) Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)
Secondary PTSD symptoms Measured by the Post traumatic stress disorder checklist scale according to DSM-5 (PCL-5, 0 (not at all) to 80 (extremely) range) Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)
Secondary Somatic symptoms Measured by the Patient Health Questionnaire 15 (PHQ-15, 0 (normal) to 30 (severe) symptom range ) Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)
Secondary Anxiety symptoms Measured by the Generalised Anxiety Disorder 7 (GAD-7, 0 (minimal) to 21 (severe) symptom range) Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)
Secondary Depressive symptoms Measured by the Patient Health Questionnaire 9 (PHQ-9, 0 (no suspicion of) to 27 (suspicion of severe) depression range) Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)
Secondary Post migration stressors Measured by the Post-migratory life difficulties Checklist (PMLD-CL, 0 (no) to 4 (very serious) post migration problem scores) Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)
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