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临床试验/NCT04781166
NCT04781166终止不适用

An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related

University of California, Berkeley1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2021年4月15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
2
试验地点
1
主要终点
Change in suicidal ideation among adults

研究概览

简要总结

The goal of this program is to test a brief, online, cognitive behavioral intervention for people who struggle with self-harm or suicidal urges or behavior in the context of emotion-related impulsivity.

详细描述

Participants will be asked to complete 7 brief online modules to cover how to understand emotion-triggered impulsivity, to better detect states of high emotion and arousal, to learn new strategies for self-calming high arousal, and to pre-plan how to cope with high arousal states. As part of the program, participants receive daily texts and prompts to remind them of the intervention content and skills. At baseline and follow-up, participants will complete measures of emotion-related impulsivity, self-harm, and suicidality.

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)

盲法说明

Interview-based assessments will be conducted by personnel who are unaware of treatment condition.

入排标准

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

入选标准

  • •at least 13 years of age
  • •engaged in mental health care
  • •evidence of either self-harm or suicidal urges or behavior in the past 3 months
  • •high levels of emotion-related impulsivity.

排除标准

  • •inability to adequately take part in the online measures due to problems with intellectual function, language, or other conditions,
  • •psychosis,
  • •not currently living in California,
  • •lack of access to a device to privately complete online modules.

研究组 & 干预措施

Intervention

Experimental

Participants will be immediately assigned to the intervention.

干预措施: Calm program (Behavioral)

Waitlist control

Other

Participants will complete measures before and after a waitlist equivalent to the duration of the intervention, to assess whether change is observed with time and repeated assessment. After the waitlist control, participants will be provided the opportunity to take part in the intervention. In this RDICT design, the pre- post- treatment data will be included in analyses.

干预措施: Calm program (Behavioral)

结局指标

主要结局

Change in suicidal ideation among adults

时间窗: immediately before the intervention and one week after intervention

Columbia Suicide Severity Rating scale suicidal ideation severity score; scores range from 0 to 5, where 5 is more severe.

Change in self-rated deliberate self-harm

时间窗: immediately before the intervention and one week after intervention

Deliberate Self-Harm Inventory Frequency in past month score, from 0 to number of incidents reported (higher scores are worse outcomes)

Change in interview-rated suicidal ideation among adolescent patients

时间窗: immediately before the intervention and one week after intervention

Self-Injurious Thoughts and Behaviors Interview suicidal ideation in the past month scored as the sum of the items on the worst intensity, average intensity, and likelihood of suicidal ideation items; scores range from 0 to 12, with higher scores reflecting greater severity.

Change in self-rated suicidal ideation among adolescent patients

时间窗: immediately before the intervention and one week after intervention

Suicide Ideation Questionnaire Jr; scores range from 0 to 6, where 6 is more severe

Change in impulsivity

时间窗: immediately before the intervention and one week after intervention

self-rated Three factor impulsivity Feelings Trigger Action subscale; scores range from 1 to 5, where 5 reflects more severe impulsivity

Change in interview-based self-harm among adolescent patients

时间窗: immediately before the intervention and one week after intervention

Self-Injurious Thoughts and Behaviors Interview NSSI severity in the past month, scored as the sum of the items on the worst intensity, average intensity, and likelihood of NSSI items; scores range from 0 to 12 with higher scores reflecting greater severity.

Change in interview-based impulsivity among adolescent patients

时间窗: immediately before the intervention and one week after intervention

Urgency interview scores, scored as the sum of 8 items, range = 0 to 16, where higher scores reflect more impulsivity.

次要结局

  • Change in aggression(immediately before the intervention and one week after intervention)

研究者

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

Sheri L. Johnson

Professor

University of California, Berkeley

研究点 (1)

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