Preventing mental disorders in displaced women in Ukraine
Preventing Mental Disorders Among Women Internally Displaced by War in Ukraine: The SHAWL Trial
This study is testing if a short group therapy session can help recently displaced women in Ukraine feel better and prevent mental health issues like anxiety and depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Kyiv) |
| Trial ID | NCT06679114 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a single-session Acceptance and Commitment Therapy (ACT) group intervention aimed at preventing mental health disorders among recently displaced women in Ukraine. With the ongoing war causing significant displacement, many women are experiencing mild to moderate symptoms of anxiety and depression. The study will recruit 120 participants who will receive either the ACT intervention or attention control to assess improvements in their mental health. The focus is on enhancing psychological flexibility through evidence-based therapeutic techniques.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and over who have been displaced within the last year and are experiencing mild to moderate depressive or anxiety symptoms.
Not a fit: Patients with a diagnosed depressive or anxiety disorder requiring urgent care or those who have received psychiatric treatment in the past five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of mental health disorders among displaced women in Ukraine.
How similar studies have performed: Other studies utilizing Acceptance and Commitment Therapy have shown promise in improving mental health outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kyiv
- Alliance for Public Health — Kyiv, Ukraine (Recruiting)
Study contacts
- Principal investigator: Karsten Lunze, MD DrPH MPH — CABUSchool of Medicine, General Internal Medicine
- Study coordinator: Karsten Lunze, MD DrPH MPH
- Email: lunze@bu.edu
- Phone: 617-414-6933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.