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Search / Trial NCT06679114

Preventing Mental Disorders Among Women Internally Displaced by War in Ukraine: The SHAWL Trial

Launched by BOSTON MEDICAL CENTER · Nov 6, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Displacement Women's Health Ukraine

ClinConnect Summary

The SHAWL Trial is a research study aimed at helping women who have been displaced by war in Ukraine. Specifically, it is looking at how effective a brief group therapy session called Acceptance and Commitment Therapy (ACT) can be in preventing mental health issues like anxiety and depression from developing or worsening in these women. The trial involves 120 participants who will take part in this therapy to see if it can improve their mental well-being.

To be eligible for the study, women must be at least 18 years old and have been displaced within the last year. They should be experiencing mild to moderate symptoms of depression or anxiety but not have a serious mental health diagnosis or be receiving current psychiatric care. Participants will need to speak either Ukrainian or Russian and be able to give their consent to join the study. If chosen, they can expect to attend a single group therapy session designed to support their mental health in these challenging times.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Age 18 or over
  • Identify as a displaced woman within one year of migration
  • Endorsing mild to moderate depressive symptoms (subscale score between 3 and 7) and/or anxiety symptoms (subscale score between 2 and 6) on the Mental Health Assessment Inventory (MHAI) but not exceeding the maximum score for either subscale (i.e., not exceeding 7 on the depressive symptoms subscale and not exceeding 6 on the anxiety symptoms subscale)
  • Ability to provide informed consent
  • Speak Ukrainian or Russian
  • Exclusion Criteria:
  • Diagnosis of a depressive or anxiety disorder, or symptoms necessitating urgent referral for evaluation of suicidal or homicidal ideation
  • Receipt of psychiatric care for depression or anxiety in the past 5 years
  • A severe medical problem that inhibits ability to participate in the trial

About Boston Medical Center

Boston Medical Center (BMC) is a leading academic medical center located in Boston, Massachusetts, dedicated to providing high-quality, compassionate care to diverse populations. As a prominent clinical trial sponsor, BMC conducts innovative research aimed at advancing medical knowledge and improving patient outcomes across a wide range of specialties. With a commitment to health equity and access to care, BMC collaborates with various stakeholders, including academic institutions and industry partners, to facilitate groundbreaking studies and translate findings into effective treatments. Its robust infrastructure and experienced research teams ensure adherence to the highest ethical standards and regulatory compliance in all clinical trials.

Locations

Kyiv, , Ukraine

Patients applied

0 patients applied

Trial Officials

Karsten Lunze, MD DrPH MPH

Principal Investigator

CABUSchool of Medicine, General Internal Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported