Mental health assessment of adult people living in different parts of Ukraine and in the Ukrainian diaspora (Canton Zurich)
| ISRCTN | ISRCTN17240415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17240415 |
- Submission date
- 11/01/2024
- Registration date
- 15/01/2024
- Last edited
- 31/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
While the long-term, population-level mental health impact of Russia's invasion of Ukraine on February 24, 2022, cannot yet be fully predicted, high demand for mental health and psychosocial support is anticipated in a post-war context. Since no public mental health surveillance exists in Ukraine, or in the Ukrainian diaspora, our aim is to assess and monitor mental health and health care needs of people living across Ukraine and in the diaspora (Canton Zurich), thus facilitating adapted and responsive mental health care planning and provision.
The aim of this study is the Mental Health Assessment of the Population project implement agile, digital surveillance of public mental health in adult people living in different parts of Ukraine and in the Ukrainian diaspora (Canton Zurich).
Who can participate?
Eligible participants for this study include adults (age ≥18 years) who are residents of Ukraine, as well as adults from Ukraine with refugee status S, currently residing in the Canton of Zurich. Additionally, adults (age ≥18 years) residing in the Canton of Zurich are invited to participate. To be eligible, individuals must provide informed consent and possess the ability to complete the surveys, available in both Ukrainian and German, either online or through a phone interview.
What does the study involve?
Mental Health Assessment of the Population (MAP) study conducts by a team of Swiss and Ukrainian researchers and focuses on mental health surveillance of adult people living in different parts of Ukraine and displaced Ukrainian citizens living in Canton Zurich. Baseline assessments will be conducted in February 2024. Follow-up assessments will take place every three months after baseline for at least two years.
The digital monitoring system will be designed to be cost effective, have a low participation burden, be responsive to changing information needs of Ukrainian stakeholders. Participants will be selected based on random sampling. Data will be collected through a secure digital study platform (REDCap). The results will be displayed in almost real-time on an online platform. Therefore, well before results are available in conventional scientific communication channels, the public, scientists, humanitarian organizations and policymakers can monitor the prevalence of PTSD, depression, anxiety, and alcohol use disorder among the general population, their trajectories over time, and by subgroup.
What are the possible benefits and risks of participating?
MAP will create a robust, longitudinal mental health surveillance that will provide policy- and decision-makers with essential, high-quality data to make informed and timely decisions on mental health care and support in Ukraine. Establishing a mental health surveillance at the country level will provide vital information for the government to assess healthcare needs, formulate policies and programmes for psychological support, focusing efforts on areas which require most attention.
Data security: As with any online study, there is a small risk of threats to the security of stored personal and sensitive data. We will minimize this risk by relying on UZH infrastructure (Science IT), which provides high levels of data security, by anonymization of stored data and separate storage of information about participants identification. We will rely on our long-term experience with Science IT with the Swiss MS Registry, a particularly sensitive project, and studies at our institute. We will be in regular exchange with the cyber security officer of UZH.
Psychological distress: it is possible that confrontation with personal psychiatric symptoms or reflection on traumatic events may cause psychological distress in participants. We will minimize this risk by relying on established questionnaires for the identification symptoms only, by keeping the length of the survey to the minimum necessary and by providing information on access to hotlines, acute psychiatric support.
Where is the study run from?
University of Zurich (Switzerland)
When is the study starting and how long is it expected to run for?
November 2023 to January 2026
Who is funding the study?
1. Canton Zurich (Entwicklungszusammenarbeit) (Switzerland)
2. University of Zurich (Switzerland)
Who is the main contact?
Prof. Dr. med. et PhD Milo Puhan, miloalan.puhan@uzh.ch
Contact information
Public, Scientific, Principal Investigator
Hirschengraben 84
Zurich
8001
Switzerland
 ORCID ID |
0000-0003-4721-1879 |
|---|---|
| Phone | +41 44 634 46 10 |
| miloalan.puhan@uzh.ch |
Public, Scientific
Hirschengraben 84
Zurich
8001
Switzerland
| ORCID ID |
0000-0003-3250-2112 |
|---|---|
| Phone | +41 44 634 46 54 |
| viktoriia.yasenok@uzh.ch |
Study information
| Study design | Prospective population-based digital cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community |
| Study type | Quality of life, Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Mental Health Assessment of the Population |
| Study acronym | MAP |
| Study objectives | The overall aim of this study is to implement agile, digital surveillance of public mental health in adult people living in different parts of Ukraine and in the Ukrainian diaspora (Canton Zurich). The specific objectives are: 1. To determine the prevalence of symptoms of PTSD, depression, anxiety, and alcohol abuse at the beginning of the surveillance, and at follow-up intervals of every three months until two years. Short-term and long-term temporal development in the Ukrainian general population (in Ukraine and in the Canton of Zurich) and subgroups defined by age, region, and level of war-related exposure will also be monitored. 2. To assess how mental health impacts general health and health care seeking behaviour. 3. To assess needs, preferences, barriers, and facilitators for mental health care services of the Ukrainian general population and subgroups. |
| Ethics approval(s) |
1. Approved 13/02/2024, Cantonal Ethics Committee Zurich (Stampfenbachstrasse 121, Zurich, CH-8090, Switzerland; +41 43 259 79 70; info.kek@kek.zh.ch), ref: 2023-02247 2. Approved 14/11/2023, Commission on Bioethics of Sumy State University (Sanatorna 1, Sumy, 40018, Ukraine; +380542660950; info@med.sumdu.edu.ua), ref: 60-0274 |
| Health condition(s) or problem(s) studied | Prevalence and incidence of post-traumatic stress disorder, depression, anxiety, and alcohol use disorder |
| Intervention | Upon enrolment, participants, who are residents of Ukraine will complete the baseline assessment through a secure digital study platform (REDCap). To access REDCap for the baseline and follow-up assessments, participants will receive an e-mail (automated, including reminders) containing a link to the respective assessment. For the Ukrainians with refugee status S residing in the Canton of Zurich and general population of the Canton of Zurich, the initial contact will be established by postal mail. Participants will not need a specific app, but simply a web browser on their computer, tablet or smartphone. Follow-up assessments will take place every three months for at least 2 years. |
| Intervention type | Other |
| Primary outcome measure | Measured at baseline and then every 12 weeks for 2 years: 1. PSTD measured using Posttraumatic Stress Disorder Checklist (PCL-5) 2. Depression measured using Patient Health Questionnaire (PHQ)-9 3. Anxiety measured using generalized anxiety disorder 7 (GAD-7) 4. Alcohol use disorder measured using Alcohol Use Disorders Identification Test (AUDIT) |
| Secondary outcome measures | Current secondary outcome measures as of 08/07/2024: Measured at baseline and then every 12 weeks for 2 years: 1. General health (as measured by the Feeling Thermometer from the European Quality of Life 5 Dimensions (EQ-5D) questionnaire, as well as five questions of the EQ-5D, describing the participant’s health: mobility, self-care, usual activities, pain/discomfort, anxiety/depression), experiences of somatic distress syndrome (PHQ-15) 2. To measure social isolation and social integration we used questions taken from the Swiss Health Survey (2022) 3. Needs, preferences, barriers, and facilitators for mental health services will be assessed by closed-ended questions (based on pre-defined dropdown options) Previous secondary outcome measures: Measured at baseline and then every 12 weeks for 2 years: 1. General health (as measured by the Feeling Thermometer from the European Quality of Life 5 Dimensions (EQ-5D) questionnaire, as well as five questions of the EQ-5D, describing the participant’s health: mobility, self-care, usual activities, pain/discomfort, anxiety/depression), experiences of somatic distress syndrome (PHQ-15), and one question about suicidal thoughts) 2. To measure social isolation and social integration we used questions taken from the Swiss Health Survey (2022) 3. Needs, preferences, barriers, and facilitators for mental health services will be assessed by closed-ended questions (based on pre-defined dropdown options) |
| Overall study start date | 14/11/2023 |
| Completion date | 31/01/2026 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | Both |
| Target number of participants | A target sample size of the population living in Ukraine is 5,220 persons; A target sample size of the Ukrainian population living in Zurich is 1,220 persons; A target sample size of the general population of the Canton of Zurich is 1,740 persons |
| Total final enrolment | 8180 |
| Key inclusion criteria | 1. Adults (age ≥18 years) who are residents of Ukraine. 2. Adults (age ≥18 years) from Ukraine with refugee status S residing in the Canton of Zurich. 3. Adults (age ≥18 years) residing in the Canton of Zurich. 4. Providing informed consent. 5. Being able to complete the surveys (available in Ukrainian and German) online or by phone interview. |
| Key exclusion criteria | Persons who cannot be reached on multiple attempts. |
| Date of first enrolment | 25/03/2024 |
| Date of final enrolment | 15/08/2024 |
Locations
Countries of recruitment
- Switzerland
- Ukraine
Study participating centres
Zurich
8001
Switzerland
Sumy
40007
Ukraine
Sponsor information
University/education
Hirschengraben 84
Zurich
8001
Switzerland
| Phone | +41 44 634 46 10 |
|---|---|
| miloalan.puhan@uzh.ch | |
| Website | http://www.uzh.ch/index_en.html |
"ROR" |
https://ror.org/02crff812 |
Funders
Funder type
Not defined
Government organisation / Local government
- Alternative name(s)
- Canton Zurich
- Location
- Switzerland
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Zurich, Switzerland, University of Zurich, UZH
- Location
- Switzerland
Results and Publications
| Intention to publish date | 15/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results of the study will be published in a high-impact peer-reviewed scientific journals. |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from Prof. Dr. med. et phil. Milo A. Puhan, Director Epidemiology, Biostatistics and Prevention Institute (EBPI) University of Zurich, email: miloalan.puhan@uzh.ch |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 13/01/2025 | 31/01/2025 | Yes | No |
Editorial Notes
31/01/2025: Publication reference added.
08/07/2024: The following changes were made to the study record:
1. The secondary outcome measures were updated.
2. The target number of participants was changed from 'A target sample size of the population living in Ukraine is 17,400 persons; A target sample size of the Ukrainian population living in Zurich is 1,740 persons; A target sample size of the general population of the Canton of Zurich is 1,740 persons' to 'A target sample size of the population living in Ukraine is 5,220 persons; A target sample size of the Ukrainian population living in Zurich is 1,220 persons; A target sample size of the general population of the Canton of Zurich is 1,740 persons'.
3. The recruitment end date was changed from 05/07/2024 to 15/08/2024.
04/06/2024: The recruitment end date was changed from 05/06/2024 to 05/07/2024.
03/05/2024: The recruitment end date was changed from 05/05/2024 to 05/06/2024.
08/03/2024: The following changes were made to the study record:
1. Study website added.
2. The recruitment start date was changed from 11/03/2024 to 25/03/2024.
3. The recruitment end date was changed from 30/04/2024 to 05/05/2024.
14/02/2024: The following changes were made:
1. The recruitment start date was changed from 20/02/2024 to 11/03/2024.
2. The approval date from the Cantonal Ethics Committee Zurich was added.
12/01/2024: Trial's existence confirmed by Commission on Bioethics of Sumy State University.
