App-based Psychosocial Intervention to Enhance Quality of Life in Arabic-speaking Refugees Residing in Switzerland

Depression Clinical Trial

— Sui  

Official title:

Efficacy of an Unguided or Peer-guided App-based Psychosocial Intervention to Enhance Quality of Life in Arabic-speaking Refugees Residing in Switzerland: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05651737
• Other study ID #: 2022-00607
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 21, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• 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: Active, not recruiting
• Enrollment: 170
• Est. completion date: July 31, 2024
• Est. primary completion date: March 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

Related Conditions & MeSH terms

• Anxiety
• Depression
• PTSD
• Quality of Life
• Stigma, Social

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)

External Links

•   Study Website Arabic