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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-15', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive symptoms', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Anxiety symptoms', 'timeFrame': 'Baseline', 'description': '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.'}]}, 'conditionsModule': {'conditions': ['Refugee', 'Mental Health', 'War Injury']}, 'referencesModule': {'references': [{'pmid': '32611475', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '37864995', 'type': 'BACKGROUND', 'citation': 'Guerrero 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.'}, {'pmid': '36554321', 'type': 'BACKGROUND', 'citation': 'Rizzi 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.'}, {'pmid': '35487232', 'type': 'BACKGROUND', 'citation': 'Mesa-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.'}, {'pmid': '38027618', 'type': 'BACKGROUND', 'citation': 'Asanov 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.'}, {'pmid': '37119352', 'type': 'BACKGROUND', 'citation': 'Zasiekina 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.'}, {'pmid': '36625445', 'type': 'BACKGROUND', 'citation': 'Karatzias 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.'}, {'pmid': '30298022', 'type': 'BACKGROUND', 'citation': 'Morina 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nHypothesis: The migration process and/or exposure to news related to the war in Ukraine negatively affect the mental health of refugees.\n\nObjectives: 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.\n\nMethodology: 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.\n\nExpected 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.\n\nApplicability 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.', 'detailedDescription': "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.\n\nThe study will be conducted over a minimum period of three months, which may be extended if it is necessary to expand the sample.\n\nThe 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.\n\nThe 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.\n\nThe sample will be selected according to inclusion and exclusion criteria, using non-probability convenience sampling, without dividing participants by gender.\n\nThe 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.\n\nAt 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.\n\nIn 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.\n\nAnalysis: 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ukrainian refugees who arrived in Spain after the start of the war in Ukraine and are currently residing in the province of Tarragona.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ukrainian nationals who arrived in Spain following the outbreak of war in Ukraine in February 2022.\n* Have reached the age of majority before participating in the study.\n* Have been recognized by the competent Spanish authority as applicants for temporary protection due to the outbreak of war in Ukraine.\n* Reside in the province of Tarragona at the time of participation in the study.\n* Have given written consent to participate in the study.\n\nExclusion Criteria:\n\n* 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).\n* Not having electronic devices (computer, mobile phone, etc.) to participate in the study."}, 'identificationModule': {'nctId': 'NCT07427056', 'briefTitle': 'Impact of the War in Ukraine on the Mental Health of Refugees Residing in Spain', 'organization': {'class': 'OTHER', 'fullName': 'Institut Investigacio Sanitaria Pere Virgili'}, 'officialTitle': 'Impact of the War in Ukraine on the Mental Health of Refugees Residing in Spain', 'orgStudyIdInfo': {'id': '24/241-P'}}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'IDIAP Jordi Gol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Investigacio Sanitaria Pere Virgili', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse', 'investigatorFullName': 'OlgaFil', 'investigatorAffiliation': 'Institut Investigacio Sanitaria Pere Virgili'}}}}