Quality of LifeSuiNCT05651737
App-based Psychosocial Intervention to Enhance Quality of Life in Arabic-speaking Refugees Residing in Switzerland
A study testing Sui App (SRK) in people with Quality of Life and Stigma, Social, run by University of Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Stigma, Social, Depression
- What is being tested?
- Sui App (SRK)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Oct 2022to 27 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Sui App (SRK)
- Medical subject headings
- Social Stigma, Depression, Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sui App (SRK)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Follow-Up (after 16 weeks)
Secondary outcomes (7)
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
Measured: 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)
Measured: 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)
Measured: 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 )
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start21 Oct 2022
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Transfusion SRC, Freie Universität Berlin
- Responsible party
- Sponsor
- Investigators
- Thomas Berger, Prof. Dr., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651737
- Sponsor's protocol ID
- 2022-00607
- Acronym
- Sui
- Status last verified
- May 2024
- First submitted
- 7 Dec 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05651737
- Acronym / sponsor ID
- Sui / 2022-00607
- Conditions
- Quality of Life, Stigma, Social, Depression, PTSD, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Swiss Transfusion SRC, Freie Universität Berlin
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sui App+ (peer guided) | Active comparator | Behavioral: Sui App (SRK)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. |
| Sui App (unguided) | Active comparator | Behavioral: Sui App (SRK)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. |
| Waitlist control group | No intervention | –The control arm is a waitlist control group that receives access to the app after eight weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Sui App (unguided), Sui App+ (peer guided) |
Primary outcome
Well-being at baseline
Time frame: 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)
Well-being at post-intervention timepoint
Time frame: 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)
Well-being at follow-up timepoint
Time frame: 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)
7 secondary outcomes
Satisfaction with the treatment
Time frame: Post (after 8 weeks), Follow-Up (after 16 weeks)
Self-stigma
Time frame: Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)
PTSD symptoms
Time frame: Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)
Somatic symptoms
Time frame: Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)
Anxiety symptoms
Time frame: Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)
Depressive symptoms
Time frame: Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)
Post migration stressors
Time frame: Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Berger, Prof. Dr. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sui App (SRK) in people with Quality of Life and Stigma, Social, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-being at baseline (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.