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

NCT06679114 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-16

No results posted yet for this study

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

Interventions

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.

BEHAVIORAL

Attention control

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Karsten Lunze, MD DrPH MPH · CABUSchool of Medicine, General Internal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2026-01-10
Completion
2026-01-10

Countries

  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06679114 on ClinicalTrials.gov