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临床试验/NCT03463980
NCT03463980终止不适用

Compassion Meditation and ReliefLink App for Suicidal, Low-Income, African Americans

Emory University2 个研究点 分布在 1 个国家目标入组 456 人开始时间: 2010年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
456
试验地点
2
主要终点
Change in Beck Scale for Suicide Ideation (BSS) score

研究概览

简要总结

The purpose of this study is to conduct a pilot randomized controlled trial (RCT) with low-income, suicidal African American women and men that compares the relative effectiveness of compassion meditation (CM) versus a support group (SG) .

详细描述

The purpose of this study is to conduct a pilot randomized controlled trial (RCT) with low-income, suicidal African American women and men that compares the relative effectiveness of compassion meditation (CM) versus a support group (SG) for (1) reducing psychological distress (suicidal ideation, depressive symptoms, and shame); (2) bolstering interpersonal connectedness; and (3) enhancing self-compassion and mindfulness. It is hypothesized that at post-intervention and follow-up, compared to individuals in the SG, those in the CM intervention will endorse less psychological distress (suicidal ideation, depressive symptoms, and shame), more interpersonal connectedness, and greater levels of self-compassion and mindfulness.

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 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • self-identify as African American or Black
  • speak English
  • present to medical and psychiatric emergency rooms at Grady Health System following a suicide attempt
  • moderate level of intent associated with the attempt (SSI >= 8 required)
  • Mini Mental State Exam (MMSE) score > 22

排除标准

  • significant cognitive impairments (MMSE < 22)
  • active psychosis (diagnosed based on Psychotic Screen (PS))
  • imminently life-threatening medical condition

结局指标

主要结局

Change in Beck Scale for Suicide Ideation (BSS) score

时间窗: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)

The BSS is a self-report 19-item scale preceded by five screening items. The BSS and its screening items are intended to assess a patient's thoughts, plans and intent to commit suicide. All 24 items are rated on a three-point scale (0 to 2) total scores could range from 0 to 48. No specific cut-off scores exist to classify severity or guide patient management. Increasing scores reflect greater suicide risk, and any positive response merits investigation.

次要结局

  • Change in Experience of Shame Scale (ESS) score(Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3))
  • Change in Social Support Behaviors Scale (SSB) score(Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3))
  • Change in Beck Depression Inventory II (BDI-II) score(Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3))
  • Change in Five Facet Mindfulness Questionnaire (FFMQ) score(Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3))
  • Change in Self-Compassion Scale (SCS) score(Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3))
  • Change in Levels of Self-Criticism Scale (LOSC) score(Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3))
  • Change in Behavior Monitoring Form (BMF) score(Weekly during participation in the study up to 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadine Kaslow, PhD

Professor & Chief Psychologist

Emory University

研究点 (2)

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