RefugeeNCT07427056
Impact of the War in Ukraine on the Mental Health of Refugees Residing in Spain
An observational study of Refugee and Mental Health, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial summary
Background: Following the outbreak of war in Ukraine on 24 February 2022, thousands of Ukrainians are crossing the borders every day in search of a place that offers them stability and security. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refugee, Mental Health, War Injury
- How many people
- 123 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2024to 1 Feb 2026
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Ukrainian refugees who arrived in Spain after the start of the war in Ukraine and are currently residing in the province of Tarragona.
Who may be able to join
- Ukrainian nationals who arrived in Spain following the outbreak of war in Ukraine in February 2022.
- Have reached the age of majority before participating in the study.
- Have been recognized by the competent Spanish authority as applicants for temporary protection due to the outbreak of war in Ukraine.
- Reside in the province of Tarragona at the time of participation in the study.
- Have given written consent to participate in the study.
Who cannot join
- Presence of physical or mental limitations that interfere with the person's ability to participate in the study, such as sensory deficits (visual, auditory), disorders related to motor coordination, cognitive disorders, or disorders that hinder language (comprehension and/or speech).
- Not having electronic devices (computer, mobile phone, etc.) to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Following the outbreak of war in Ukraine on 24 February 2022, thousands of Ukrainians are crossing the borders every day in search of a place that offers them stability and security. Studies have concluded that the war has affected the mental health of Ukrainian refugees and led to the emergence of psycho-emotional disorders.
Hypothesis: The migration process and/or exposure to news related to the war in Ukraine negatively affect the mental health of refugees.
Read more
Objectives: To explore the impact on mental health caused by the war in Ukraine on the refugee population residing in the province of Tarragona after the start of the Russian invasion in 2022.
Methodology: Descriptive observational study of a quantitative and qualitative cross-sectional nature with structured surveys and semi-structured interviews. Statistical analysis will be performed using the SPSS programme and the ATLAS.ti programme or similar will be used for data analysis using qualitative methodology.
Expected results: The conditions associated with exposure to war, migration, the search for a home, and the influence of the media on mental health contribute to Ukrainian refugees exhibiting psycho-emotional disturbances and difficulties in adapting to their new location.
Applicability and relevance: The lack of scientific evidence developed in Spain on Ukrainian refugees and the need to raise awareness of this situation, as well as the possibility of contributing to the improvement of social and health policies on migration and the reception of refugees.
Read the detailed description
A mixed-methods study will be conducted, combining qualitative methodology through phenomenological analysis and semi-structured interviews with quantitative methodology through structured surveys. The study will be conducted in accordance with the guidelines established by the STROBE (STrenghtening the Reporting of OBservational studies in Epidemiology) statement.
The study will be conducted over a minimum period of three months, which may be extended if it is necessary to expand the sample.
The reference population will be Ukrainian refugees who, due to the start of the Russian invasion of Ukraine in 2022, were forced to flee the country and are currently residing in Spain.
The study population will be Ukrainian refugees who arrived in Spain after the start of the war in Ukraine and are currently residing in the province of Tarragona.
The sample will be selected according to inclusion and exclusion criteria, using non-probability convenience sampling, without dividing participants by gender.
The first part of the study will be conducted through semi-structured interviews with the aim of understanding the experiences of Ukrainian refugees during the war, covering the days leading up to the war, the day it began and the entire period thereafter, as well as the migration process and arrival at their new place of residence. A maximum limit of 10 interviews has been set, although this number may be lower if information saturation is reached.
At the beginning of the interview, the objective of the study will be explained, and participants will be informed that the interview will be recorded in audio format and subsequently transcribed by the principal investigator. Ethical considerations regarding confidentiality will be respected at all times. Informed consent will be signed, and personal data will be coded.
In the second part of the study, structured anonymous surveys will be conducted, with a total of 40 questions divided into 5 sections and lasting approximately 10-15 minutes. The anonymity of the responses will be preserved, and personal identification will not be required to access the survey at any time. The level of anxiety and depression will be assessed using validated scales (PHQ-9 and GAD-7) and the level of adaptation in the host country and exposure to war-related news will be assessed using ad hoc questionnaires.
Analysis: The interview data will be grouped by topics of interest using the ATLAS.ti programme or manually following a process of structuring, categorisation and analysis. The data obtained in the surveys will be analysed using the SPSS programme. Qualitative variables will be described using percentages and quantitative variables using the mean and standard deviation. To determine the relationship between the different variables, the Chi-square test will be applied for qualitative variables and the Student's t-test for quantitative variables. A confidence level of 95% will be assumed, considering a statistical difference between variables p ≤ 0.05 to be significant.
- Conditions
- Refugee, Mental Health, War Injury
- Medical subject headings
- Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Items are rated on a 4-point Likert scale from 0 to 3, generating a total score between 0 and 27. Higher total scores reflect greater depressive symptom severity.
Measured: Baseline
Anxiety symptoms
The 7-item Generalized Anxiety Disorder scale (GAD-7) is a self-reported measure of anxiety severity. Each item is rated on a 4-point scale from 0 to 3, resulting in a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Nov 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for RefugeeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OlgaFil, Institut Investigacio Sanitaria Pere Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427056
- Sponsor's protocol ID
- 24/241-P
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
Publications
Henkelmann JR, de Best S, Deckers C, Jensen K, Shahab M, Elzinga B, Molendijk M. Anxiety, depression and post-traumatic stress disorder in refugees resettling in high-income countries: systematic review and meta-analysis. BJPsych Open. 2020 Jul 2;6(4):e68. doi: 10.1192/bjo.2020.54.
PubMed 32611475Guerrero Z, Melicharova H, Kavanova M, Prokop D, Skvrnak M, Kunc M, Leontiyeva Y, Vitikova J, Spurny M, Pilnacek M, Kysela M, Zhmurko O, Tabery P, Winkler P. Mental health conditions and help-seeking among Ukrainian war refugees in Czechia: A cross-sectional study. Psychiatry Res. 2023 Nov;329:115552. doi: 10.1016/j.psychres.2023.115552. Epub 2023 Oct 18.
PubMed 37864995Rizzi D, Ciuffo G, Sandoli G, Mangiagalli M, de Angelis P, Scavuzzo G, Nych M, Landoni M, Ionio C. Running Away from the War in Ukraine: The Impact on Mental Health of Internally Displaced Persons (IDPs) and Refugees in Transit in Poland. Int J Environ Res Public Health. 2022 Dec 8;19(24):16439. doi: 10.3390/ijerph192416439.
PubMed 36554321Mesa-Vieira C, Haas AD, Buitrago-Garcia D, Roa-Diaz ZM, Minder B, Gamba M, Salvador D Jr, Gomez D, Lewis M, Gonzalez-Jaramillo WC, Pahud de Mortanges A, Buttia C, Muka T, Trujillo N, Franco OH. Mental health of migrants with pre-migration exposure to armed conflict: a systematic review and meta-analysis. Lancet Public Health. 2022 May;7(5):e469-e481. doi: 10.1016/S2468-2667(22)00061-5.
PubMed 35487232Asanov AM, Asanov I, Buenstorf G. Mental health and stress level of Ukrainians seeking psychological help online. Heliyon. 2023 Nov 4;9(11):e21933. doi: 10.1016/j.heliyon.2023.e21933. eCollection 2023 Nov.
PubMed 38027618Zasiekina L, Zasiekin S, Kuperman V. Post-traumatic Stress Disorder and Moral Injury Among Ukrainian Civilians During the Ongoing War. J Community Health. 2023 Oct;48(5):784-792. doi: 10.1007/s10900-023-01225-5. Epub 2023 Apr 29.
PubMed 37119352Karatzias T, Shevlin M, Ben-Ezra M, McElroy E, Redican E, Vang ML, Cloitre M, Ho GWK, Lorberg B, Martsenkovskyi D, Hyland P. War exposure, posttraumatic stress disorder, and complex posttraumatic stress disorder among parents living in Ukraine during the Russian war. Acta Psychiatr Scand. 2023 Mar;147(3):276-285. doi: 10.1111/acps.13529. Epub 2023 Jan 10.
PubMed 36625445Morina N, Akhtar A, Barth J, Schnyder U. Psychiatric Disorders in Refugees and Internally Displaced Persons After Forced Displacement: A Systematic Review. Front Psychiatry. 2018 Sep 21;9:433. doi: 10.3389/fpsyt.2018.00433. eCollection 2018.
PubMed 30298022
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the War in Ukraine on the Mental Health of Refugees Residing in Spain
- ClinicalTrials.gov ID
- NCT07427056
- Acronym / sponsor ID
- 24/241-P
- Conditions
- Refugee, Mental Health, War Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 23 Feb 2026 (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.
Background: Following the outbreak of war in Ukraine on 24 February 2022, thousands of Ukrainians are crossing the borders every day in search of a place that offers them stability and security. Studies have concluded that the war has affected the mental health of Ukrainian refugees and led to the emergence of psycho-emotional disorders.
Hypothesis: The migration process and/or exposure to news related to the war in Ukraine negatively affect the mental health of refugees.
Objectives: To explore the impact on mental health caused by the war in Ukraine on the refugee population residing in the province of Tarragona after the start of the Russian invasion in 2022.
Methodology: Descriptive observational study of a quantitative and qualitative cross-sectional nature with structured surveys and semi-structured interviews. Statistical analysis will be performed using the SPSS programme and the ATLAS.ti programme or similar will be used for data analysis using qualitative methodology.
Expected results: The conditions associated with exposure to war, migration, the search for a home, and the influence of the media on mental health contribute to Ukrainian refugees exhibiting psycho-emotional disturbances and difficulties in adapting to their new location.
Applicability and relevance: The lack of scientific evidence developed in Spain on Ukrainian refugees and the need to raise awareness of this situation, as well as the possibility of contributing to the improvement of social and health policies on migration and the reception of refugees.
Detailed description
A mixed-methods study will be conducted, combining qualitative methodology through phenomenological analysis and semi-structured interviews with quantitative methodology through structured surveys. The study will be conducted in accordance with the guidelines established by the STROBE (STrenghtening the Reporting of OBservational studies in Epidemiology) statement.
The study will be conducted over a minimum period of three months, which may be extended if it is necessary to expand the sample.
The reference population will be Ukrainian refugees who, due to the start of the Russian invasion of Ukraine in 2022, were forced to flee the country and are currently residing in Spain.
The study population will be Ukrainian refugees who arrived in Spain after the start of the war in Ukraine and are currently residing in the province of Tarragona.
The sample will be selected according to inclusion and exclusion criteria, using non-probability convenience sampling, without dividing participants by gender.
The first part of the study will be conducted through semi-structured interviews with the aim of understanding the experiences of Ukrainian refugees during the war, covering the days leading up to the war, the day it began and the entire period thereafter, as well as the migration process and arrival at their new place of residence. A maximum limit of 10 interviews has been set, although this number may be lower if information saturation is reached.
At the beginning of the interview, the objective of the study will be explained, and participants will be informed that the interview will be recorded in audio format and subsequently transcribed by the principal investigator. Ethical considerations regarding confidentiality will be respected at all times. Informed consent will be signed, and personal data will be coded.
In the second part of the study, structured anonymous surveys will be conducted, with a total of 40 questions divided into 5 sections and lasting approximately 10-15 minutes. The anonymity of the responses will be preserved, and personal identification will not be required to access the survey at any time. The level of anxiety and depression will be assessed using validated scales (PHQ-9 and GAD-7) and the level of adaptation in the host country and exposure to war-related news will be assessed using ad hoc questionnaires.
Analysis: The interview data will be grouped by topics of interest using the ATLAS.ti programme or manually following a process of structuring, categorisation and analysis. The data obtained in the surveys will be analysed using the SPSS programme. Qualitative variables will be described using percentages and quantitative variables using the mean and standard deviation. To determine the relationship between the different variables, the Chi-square test will be applied for qualitative variables and the Student's t-test for quantitative variables. A confidence level of 95% will be assumed, considering a statistical difference between variables p ≤ 0.05 to be significant.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ukrainian refugees who arrived in Spain after the start of the war in Ukraine and are currently residing in the province of Tarragona.
Key inclusion criteria (5 listed)
- Ukrainian nationals who arrived in Spain following the outbreak of war in Ukraine in February 2022.
- Have reached the age of majority before participating in the study.
- Have been recognized by the competent Spanish authority as applicants for temporary protection due to the outbreak of war in Ukraine.
- Reside in the province of Tarragona at the time of participation in the study.
- Have given written consent to participate in the study.
Key exclusion criteria (2 listed)
- Presence of physical or mental limitations that interfere with the person's ability to participate in the study, such as sensory deficits (visual, auditory), disorders related to motor coordination, cognitive disorders, or disorders that hinder language (comprehension and/or speech).
- Not having electronic devices (computer, mobile phone, etc.) to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depressive symptoms
Time frame: Baseline
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Items are rated on a 4-point Likert scale from 0 to 3, generating a total score between 0 and 27. Higher total scores reflect greater depressive symptom severity.
Anxiety symptoms
Time frame: Baseline
The 7-item Generalized Anxiety Disorder scale (GAD-7) is a self-reported measure of anxiety severity. Each item is rated on a 4-point scale from 0 to 3, resulting in a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity.
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 25 Feb 2026.
- Background: PubMed 32611475Henkelmann JR, de Best S, Deckers C, Jensen K, Shahab M, Elzinga B, Molendijk M. Anxiety, depression and post-traumatic stress disorder in refugees resettling in high-income countries: systematic review and meta-analysis. BJPsych Open. 2020 Jul 2;6(4):e68. doi: 10.1192/bjo.2020.54.
- Background: PubMed 37864995Guerrero Z, Melicharova H, Kavanova M, Prokop D, Skvrnak M, Kunc M, Leontiyeva Y, Vitikova J, Spurny M, Pilnacek M, Kysela M, Zhmurko O, Tabery P, Winkler P. Mental health conditions and help-seeking among Ukrainian war refugees in Czechia: A cross-sectional study. Psychiatry Res. 2023 Nov;329:115552. doi: 10.1016/j.psychres.2023.115552. Epub 2023 Oct 18.
- Background: PubMed 36554321Rizzi D, Ciuffo G, Sandoli G, Mangiagalli M, de Angelis P, Scavuzzo G, Nych M, Landoni M, Ionio C. Running Away from the War in Ukraine: The Impact on Mental Health of Internally Displaced Persons (IDPs) and Refugees in Transit in Poland. Int J Environ Res Public Health. 2022 Dec 8;19(24):16439. doi: 10.3390/ijerph192416439.
- Background: PubMed 35487232Mesa-Vieira C, Haas AD, Buitrago-Garcia D, Roa-Diaz ZM, Minder B, Gamba M, Salvador D Jr, Gomez D, Lewis M, Gonzalez-Jaramillo WC, Pahud de Mortanges A, Buttia C, Muka T, Trujillo N, Franco OH. Mental health of migrants with pre-migration exposure to armed conflict: a systematic review and meta-analysis. Lancet Public Health. 2022 May;7(5):e469-e481. doi: 10.1016/S2468-2667(22)00061-5.
- Background: PubMed 38027618Asanov AM, Asanov I, Buenstorf G. Mental health and stress level of Ukrainians seeking psychological help online. Heliyon. 2023 Nov 4;9(11):e21933. doi: 10.1016/j.heliyon.2023.e21933. eCollection 2023 Nov.
- Background: PubMed 37119352Zasiekina L, Zasiekin S, Kuperman V. Post-traumatic Stress Disorder and Moral Injury Among Ukrainian Civilians During the Ongoing War. J Community Health. 2023 Oct;48(5):784-792. doi: 10.1007/s10900-023-01225-5. Epub 2023 Apr 29.
- Background: PubMed 36625445Karatzias T, Shevlin M, Ben-Ezra M, McElroy E, Redican E, Vang ML, Cloitre M, Ho GWK, Lorberg B, Martsenkovskyi D, Hyland P. War exposure, posttraumatic stress disorder, and complex posttraumatic stress disorder among parents living in Ukraine during the Russian war. Acta Psychiatr Scand. 2023 Mar;147(3):276-285. doi: 10.1111/acps.13529. Epub 2023 Jan 10.
- Background: PubMed 30298022Morina N, Akhtar A, Barth J, Schnyder U. Psychiatric Disorders in Refugees and Internally Displaced Persons After Forced Displacement: A Systematic Review. Front Psychiatry. 2018 Sep 21;9:433. doi: 10.3389/fpsyt.2018.00433. eCollection 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refugee and Mental Health, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
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 5 inclusion and 2 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 25 Feb 2026. 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 Spain. 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?
Depressive symptoms (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07427056, which also lists 8 linked publications.
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 25 Feb 2026.