Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 5:48 PM
Study NCT ID:
NCT07427056
Status:
COMPLETED
Last Update Posted:
2026-02-25
First Post:
2026-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of the War in Ukraine on the Mental Health of Refugees Residing in Spain
Sponsor:
Institut Investigacio Sanitaria Pere Virgili
Organization:
Study Overview
Official Title:
Impact of the War in Ukraine on the Mental Health of Refugees Residing in Spain
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: