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临床试验/NCT06679114
NCT06679114已完成不适用

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

Boston Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Anxiety symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Behavioral: ACT Therapy

Experimental

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

干预措施: Acceptance and Commitment Therapy (Behavioral)

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.

干预措施: Attention control (Behavioral)

结局指标

主要结局

Anxiety symptoms

时间窗: 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

时间窗: 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.

次要结局

  • Experiential avoidance(Baseline, 3-months)
  • Psychological flexibility(Baseline, 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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