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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 University1 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
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
456
试验地点
1
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

研究组 & 干预措施

Support group (SG)

Active Comparator

SG participants will attend six weekly sessions, 90 minutes in length. It will be unstructured. Participants will use this time to talk about current concerns and to receive support and guidance from other group members and the leaders.

干预措施: Support group (SG) (Behavioral)

Compassion meditation (CM)

Experimental

The CM participants will attend six weekly sessions (each 120 minute), and will be video and/or audiotaped. Each weekly CM session will entail a 30 minute check-in regarding the participants' levels of suicidal ideation, as well as a discussion of current life stress and weekly meditation practice; a 30 minute didactic session that will describe the meditative technique introduced during the week; and a 30 minute guided meditation session. Participants will be encouraged to meditate at least 30 minutes a day and will be asked to track their daily meditation time and bring in their tracking sheet to each session.

干预措施: Compassion meditation (CM) (Behavioral)

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 (1)

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