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

NCT05651737 | Completed DMC

• 1 other identifier: 2022-00607
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Satisfaction with the treatment

  Post (after 8 weeks), Follow-Up (after 16 weeks)

• Self-stigma

  Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)

• PTSD symptoms

  Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)

• Somatic symptoms

  Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)

• Anxiety symptoms

  Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)

Study Arms (3)

Sui App+ (peer guided)

ACTIVE COMPARATOR

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)

Sui App (unguided)

ACTIVE COMPARATOR

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)

Waitlist control group

NO INTERVENTION

The control arm is a waitlist control group that receives access to the app after eight weeks.

Interventions

Sui App (SRK) BEHAVIORAL

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

Sui App (unguided); Sui App+ (peer guided)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead
• Swiss Transfusion SRC: collaborator
• Freie Universität Berlin: collaborator

Study Sites (1)

University of Bern

Bern, Canton of Bern, 3012, Switzerland

Location

MeSH Terms

Conditions

Social Stigma; Depression; Stress Disorders, Post-Traumatic; Anxiety Disorders

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Behavioral Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Thomas Berger, Prof. Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: October 21, 2022
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)