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临床试验/NCT06809348
NCT06809348招募中不适用

Development of PRECISE: A Data Driven Personalized Suicide Prevention Intervention

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年11月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Scale for Suicide Ideation

研究概览

简要总结

Individuals at high-risk of suicide vary substantially from one another. Over time, risk factors for suicide may change within the same individual. Despite these differences, most treatments for suicidal thoughts assume that the same intervention works equally well for all individuals at high-risk of suicide. Intensive longitudinal data combined with network science, integrated with coaching, could be used to personalize suicide prevention interventions to make them more effective and efficient. This K23 Career Development application involves refining and testing a novel personalized treatment for individuals at high-risk called PeRsonalizEd Clinical Intervention for Suicidal Events or PRECISE. PRECISE leverages idiographic statistical techniques adopted from network science applied to ecological momentary assessment data to inform the tailoring of Safety Planning and skills from Dialectical Behavior Therapy, two existing evidence-based treatments for suicide. In Aim 1, a user-centered design approach will be used to refine PRECISE. Following the refinement of the intervention, informed by data from a case series in Aim 1, the investigators will then conduct a randomized controlled trial comparing two different intensities of personalization. In the low-intensity arm, the 8-week treatment will be tailored based on an initial two-week burst of ecological momentary assessment and one idiographic model. In the high-intensity arm, participants complete eight weeks of ecological momentary assessment and idiographic models are generated between each session. Coaches use the idiographic models to identify an individuals' drivers of suicidal thoughts and conduct behavioral chain analyses to tailor specific skills to then teach, shape, and reinforce in their individual clients. Assessments are completed pre-treatment, 8-weeks post-enrollment, and 16-weeks enrollment. The investigators hypothesize that both arms will demonstrate clinically significant reductions in suicidal ideation, but the high-intensity arm will be superior to the low-intensity arm in reducing ideation. Furthermore, the investigators anticipate that increases in effective emotion regulation skills and reductions in negative affect will account for the decrease in suicidal ideation. As individuals learn more effective emotion regulation strategies, they will experience less distress and thereby lower levels of suicidal ideation. This project is responsive to Objective 3.2 of the NIMH Strategic Plan and is integrated with a mentored research training plan focused on 1) suicide specific rigorous clinical trials, 2) user centered design in digital health, and 3) applications of network science to intensive longitudinal data. The project and training goal will support the Candidate's overarching goal to become a clinician-scientist engaged in independent research on personalized, impactful, rapid acting suicide prevention interventions for at risk adults.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years old
  • Endorsement of active suicidal ideation on the Columbia Suicide Severity Rating Scale (>2 or past month thoughts of killing self or attempt in past month)
  • English fluency
  • Willingness to provide contact information for a key information to be contacted as part of our risk and safety plan.

排除标准

  • Past year exposure to DBT
  • Moderate/severe substance use disorder within the past thirty days
  • Dementia, mild cognitive impairment and/or traumatic brain injury
  • Lack of capacity to consent to research and/or under conservatorship.

研究组 & 干预措施

High-Intensity

Experimental

In the high intensity arm, participants will complete all eight weeks of EMA with idiographic models generated between each session. Coaches then shape selection of skills in collaboration with the patient and a treatment plan for the next session will be generated.

干预措施: PRECISE (Behavioral)

Low-Intensity

Experimental

In the low intensity arm, participants will complete only an initial two weeks burst of EMA and GIMME will be run following an initial burst. A treatment plan for the next eight weeks will be generated based on the output.

干预措施: PRECISE (Behavioral)

结局指标

主要结局

Scale for Suicide Ideation

时间窗: From enrollment to the end of the follow-up assessment at 6-months.

The Beck Scale for Suicide Ideation (SSI) is a 21-item self-report scale that measure the intensity of suicidal thoughts. The MSSI ranges from 0 \[min\] to 63 \[max\] with higher scores suggesting more severe suicidal ideation.

次要结局

  • Emotion Reactivity Scale(From enrollment to the end of the follow-up assessment at 6-months.)
  • Cognitive Emotion Regulation Questionnaire(From enrollment to the end of the follow-up assessment at 6-months.)

研究者

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

Kevin Kuehn

Assistant Adjunct Professor

University of California, San Diego

研究点 (1)

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