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

Not Applicable

Recruiting

• Conditions: Anxiety; Mental Health Disorder; War-Related Trauma; Acceptance and Commitment Therapy; Depressive Symptoms Mild to Moderate in Severity; Refugee Health; Prevention

• Registration Number: NCT06679114
• Lead Sponsor: Boston Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-06
• Study First Posted: 2024-11-07
• Status Verified: 2025-03
• Study Start: 2025-03-27
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-28
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety symptoms	Baseline, 3 months	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.
Depressive symptoms	Baseline, 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Experiential avoidance	Baseline, 3-months	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.
Psychological flexibility	Baseline, 3 months	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.

Trial Locations

Locations (1)

Alliance for Public Health; 🇺🇦 Kyiv, Ukraine