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

NCT06679114 | Completed DMC

• 2 other identifiers: H-45281R34MH134077
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Displacement; Women's health; Ukraine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Experiential avoidance

  Baseline, 3-months

• Psychological flexibility

  Baseline, 3 months

Study Arms (2)

Behavioral: ACT Therapy

EXPERIMENTAL

Participants randomized to this group will receive a single-session ACT intervention

Behavioral: Acceptance and Commitment Therapy

Attention control

ACTIVE COMPARATOR

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

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

Behavioral: ACT Therapy

Attention control BEHAVIORAL

Usual care will be minimally enhanced by providing participants with an educational information session that provides information on health promotion.

Attention control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Alliance for Public Health

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Anxiety Disorders; Mental Disorders; War-Related Injuries

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Karsten Lunze, MD DrPH MPH

  CABUSchool of Medicine, General Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: March 27, 2025
• Primary Completion: January 10, 2026
• Study Completion: January 10, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)