Clinical trial NCT06679114: Preventing Mental Disorders Among Women Internally Displaced by War in Ukraine: The SHAWL Trial
Official title: Preventing Mental Disorders Among Women Internally Displaced by War in Ukraine: The SHAWL Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-11-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Anxiety symptoms
timeFrame: Baseline, 3 months
measure: Depressive symptoms
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Experiential avoidance
timeFrame: Baseline, 3-months
measure: Psychological flexibility
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Alliance for Public Health
Study officials:
affiliation: CABUSchool of Medicine, General Internal Medicine
name: Karsten Lunze, MD DrPH MPH
role: PRINCIPAL_INVESTIGATOR
References: