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

This study is a randomized controlled trial among 120 recently displaced women to determine the effectiveness of a single-session Acceptance and Commitment Therapy (ACT) group therapy on prevention of development of mental health disorders or worsened mental health symptoms.

Study Overview

• Status: Completed
• Conditions: Anxiety; Mental Health Disorder; Acceptance and Commitment Therapy; Prevention; War-Related Trauma; Refugee Health; Depressive Symptoms Mild to Moderate in Severity
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy; Behavioral: Attention control

Detailed Description

The war in Ukraine has provoked the world's current largest humanitarian displacement: since February 2022, one-third of Ukrainians have been forced to leave their homes, resulting in upwards of 7 million internally displaced persons. Estimates suggest that 60% of Ukraine's displaced persons are women, who face stressors including difficulty accessing necessary primary health and psychological care, restricted access to food and stable housing, and increased strain from separation from their social networks and additional family care responsibilities.

Early reports from Ukraine consistently describe the psychological distress that displaced women are presently experiencing. It is anticipated that nearly one in five people exposed to conflict will develop mental disorders, notably depressive and anxiety disorders. Thus, improving access to mental health prevention programs that mitigate development of mental disorders for women in Ukraine is critical.

This study will adapt a community-based Acceptance and Commitment Therapy (ACT) intervention to prevent the development symptoms of depression and anxiety among women displaced by war in Ukraine. ACT is an evidence-based approach that uses acceptance, mindfulness and behavioral change processes to improve psychological flexibility. Recently displaced women who screen positive for symptoms of depression and anxiety will be recruited. The investigators plan to adapt and evaluate a single-session ACT group intervention to limit effects of mental health distress among these displaced women.

The central hypothesis of this research is that an ACT-based intervention delivered in a humanitarian context will help displaced women in Ukraine learn skills to improve psychological flexibility, thereby decreasing symptoms of depression and anxiety and ultimately mitigating onset of mental disorders.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine
    • Alliance for Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral: ACT Therapy; Participants randomized to this group will receive a single-session ACT intervention	Behavioral: Acceptance and Commitment Therapy; The single-session ACT group intervention will involve a mixture of didactic instruction, discussion, metaphors, and experiential activities. ACT activities will help women notice and accept that negative thoughts, emotions, and experiences while being displaced by war are part of migratory and post-migratory life. ACT activities will also help them identify, reorient towards, and commit to values-consistent behaviors through effective goal-setting. The single-session will be approximately 3 hours long.
Active Comparator: Attention control; Participants in the control group will receive minimally enhanced usual care to receive treatment as usual enhanced by a health information group session.	Behavioral: Attention control; Usual care will be minimally enhanced by providing participants with an educational information session that provides information on health promotion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety symptoms	Anxiety symptoms will be assessed using the Mental Health Assessment Inventory (MHAI) anxiety subscore which has 4 items, and each item is rated on a 3-point Likert scale where "0" means "none of the time" and "3" means "almost all of the time." Total score on the subscale ranges from 0-12 with higher scores indicating greater symptoms of anxiety.	Baseline, 3 months
Depressive symptoms	Depressive symptoms will be assessed using the Mental Health Assessment Inventory (MHAI) depression subscore which has 6 items, and each item is rated on a 3-point Likert scale where "0" means "none of the time" and "3" means "almost all of the time." Total score on the subscale ranges from 0-36 with higher scores indicating greater symptoms of depression.	Baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experiential avoidance	Experiential avoidance will be assessed with the Multidimensional Experiential Avoidance Questionnaire (MEAQ) which is scored by summing up responses across its 62 items. Each item is rated on a 6-point Likert scale ranging from "strongly disagree" to "strongly agree". Higher scores indicate greater levels of experiential avoidance.	Baseline, 3-months
Psychological flexibility	Psychological flexibility will be assessed using the Acceptance and Actions Questionnaire (AAQ-2) which has 7 items, and each item is rated on a 7-point Likert scale where "1" means "never true" and "7" means "always true". Scores can range from 7 to 49. The higher the score, the more someone tends to avoid unwanted thoughts and feelings, signifying less psychological flexibility.	Baseline, 3 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Karsten Lunze, MD DrPH MPH, CABUSchool of Medicine, General Internal Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2025
• Primary Completion (Actual): January 10, 2026
• Study Completion (Actual): January 10, 2026

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Women's health; Ukraine; Displacement
• Additional Relevant MeSH Terms: Wounds and Injuries; War-Related Injuries; Anxiety Disorders; Mental Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy
• Other Study ID Numbers: H-45281; R34MH134077 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No