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

Sponsor
University of Bern (Other)
Overall Status
Recruiting
CT.gov ID
NCT05651737
Collaborator
Swiss Transfusion SRC (Other), Freie Universit├Ąt Berlin (Other)
150
1
3
21.3
7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Sui App (SRK)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Oct 21, 2022
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Well-being at baseline [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)

  2. Well-being at post-intervention timepoint [Post (after 8 weeks)]

    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)

  3. Well-being at follow-up timepoint [Follow-Up (after 16 weeks)]

    Measured by the WHO Quality of Life Short Version (WHOQOL-BREF, 4 domain scores, mean score multiplied by 4, 0 (low) to100 (high) range)

Secondary Outcome Measures

  1. Satisfaction with the treatment [Post (after 8 weeks), Follow-Up (after 16 weeks)]

    Measured by the Questionnaire on satisfaction with the treatment (ZUF-8, 1(low) to 4 (high) scores) adapted for "app" as intervention

  2. Self-stigma [Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)]

    Measured by the Self-stigma of mental illness scale short form (SSMIS-SF, 1(strongly disagree) to 9 (strongly agree) scores)

  3. PTSD symptoms [Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)]

    Measured by the Post traumatic stress disorder checklist scale according to DSM-5 (PCL-5, 0 (not at all) to 80 (extremely) range)

  4. Somatic symptoms [Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)]

    Measured by the Patient Health Questionnaire 15 (PHQ-15, 0 (normal) to 30 (severe) symptom range )

  5. Anxiety symptoms [Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)]

    Measured by the Generalised Anxiety Disorder 7 (GAD-7, 0 (minimal) to 21 (severe) symptom range)

  6. Depressive symptoms [Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)]

    Measured by the Patient Health Questionnaire 9 (PHQ-9, 0 (no suspicion of) to 27 (suspicion of severe) depression range)

  7. Post migration stressors [Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)]

    Measured by the Post-migratory life difficulties Checklist (PMLD-CL, 0 (no) to 4 (very serious) post migration problem scores)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Bern Bern BE Switzerland 3012

Sponsors and Collaborators

  • University of Bern
  • Swiss Transfusion SRC
  • Freie Universit├Ąt Berlin

Investigators

  • Principal Investigator: Thomas Berger, Prof. Dr., University of Bern

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of Bern
ClinicalTrials.gov Identifier:
NCT05651737
Other Study ID Numbers:
  • 2022-00607
First Posted:
Dec 15, 2022
Last Update Posted:
Dec 22, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 22, 2022