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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; PTSD; Quality of Life; Anxiety; Stigma, Social
• Intervention / Treatment: Behavioral: Sui App (SRK)

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • BE
    • Bern, BE, Switzerland, 3012
      • University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sui App+ (peer guided); The active phase of the study is eight weeks per participant with a follow-up online assessment after another eight weeks. One of the active study groups, the Sui App+ condition, receives the Sui app plus a peer who will guide them online. They receive weekly individual messages from their peer within the chat of the app.	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
Active Comparator: Sui App (unguided); The active phase of the study is eight weeks per participant with a follow-up online assessment after another eight weeks. The second active study group receives the app as a standalone intervention. They use whatever content they are interested in and receive weekly push-notifications in case they were not active.	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
No Intervention: Waitlist control group; The control arm is a waitlist control group that receives access to the app after eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: Freie Universität Berlin; Swiss Transfusion SRC
• Investigators: Principal Investigator: Thomas Berger, Prof. Dr., University of Bern

Publications and helpful links

Helpful Links

• Study Website Arabic

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Actual): March 27, 2024
• Study Completion (Actual): March 27, 2024

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022-00607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No