跳至主要内容
临床试验/NCT05440214
NCT05440214招募中不适用

Targeting Emotion Dysregulation to Reduce Suicide in People With Psychosis

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
68
试验地点
2
主要终点
Emotion Dysregulation

研究概览

简要总结

People with psychotic disorders are excluded from most suicide-focused clinical trials despite incredibly high rates of completed suicide, and interventions that have been tested for this population have shown limited impact on suicide. Emotion dysregulation is a significant suicidogenic factor that is understudied in people with psychotic disorders. The investigators propose to implement and evaluate an intervention targeting emotion dysregulation in people with psychotic disorders while employing rigorous statistical modeling and measurement techniques including Ecological Momentary Assessment, which will support future advanced research on suicide and suicide prevention for this high-risk group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • At least 18 years old
  • Psychosis spectrum disorder as assessed by the Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorder Studies
  • Heightened suicide risk as determined by a score of 8+ on the Suicide Behaviors Questionnaire-Revised (SBQ-R). This cutoff may be revised downwards (toward lower suicide risk) if recruitment appears difficult, but will not be revised upwards.
  • Enrollment and engagement in outpatient mental health services with at least one mental health service in the previous month
  • 6+ grade equivalent reading level as assessed by the Wide Range Achievement Test 4 (WRAT-4)

排除标准

  • Chart diagnosis of intellectual disability (DSM5 317, 318), traumatic brain injury, or deafness.

结局指标

主要结局

Emotion Dysregulation

时间窗: Four months

Difficulties in Emotion Regulation Scale (DERS-36). Minimum score: 36. Maximum score: 180. Higher scores are worse.

Suicidal Ideation

时间窗: Four months

Beck Scale for Suicide Ideation. Minimum score: 0. Maximum score: 42. Higher scores are worse.

次要结局

未报告次要终点

研究者

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

Peter Phalen

Assistant Professor

University of Maryland, Baltimore

研究点 (2)

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