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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: Sui App (SRK)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sui App+ (peer guided)<br>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)<br>* 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<br>|
| Active Comparator: Sui App (unguided)<br>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)<br>* 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<br>|
| No Intervention: Waitlist control group<br>The control arm is a waitlist control group that receives access to the app after eight weeks. | |

What is the study measuring?
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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) |