NCT07427056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 15, 2026

Last Update Submit

February 23, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDIAP Jordi Gol

Barcelona, Spain

Location

Related Publications (8)

  • 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: 32611475BACKGROUND
  • 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: 37864995BACKGROUND
  • 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: 36554321BACKGROUND
  • 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: 35487232BACKGROUND
  • 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: 38027618BACKGROUND
  • 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: 37119352BACKGROUND
  • 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: 36625445BACKGROUND
  • 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.

    PMID: 30298022BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

February 15, 2026

First Posted

February 23, 2026

Study Start

November 1, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations