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临床试验/NCT04054947
NCT04054947已完成不适用

Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios

White River Junction Veterans Affairs Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
The Beck Scale for Suicidal Ideation (BSS)

研究概览

简要总结

In the United States (U.S.), suicide is a major public health concern. U.S. Veterans who live in rural areas may be at even higher risk for suicide than their urban counterparts. Available evidence indicates that suicide risk in rural U.S. Veterans is most concentrated during high-risk care transition scenarios such as discharge from an emergency room. There is limited knowledge about effective interventions to address suicide risk. There is a critical need to develop targeted interventions that address suicide risk during high-risk care transition periods. To be effective, these interventions should address key contributors to suicide risk such as reduced engagement in treatment. This clinical trial evaluates the effect of a suicide prevention intervention to support treatment engagement during high risk transition periods such as discharge from an emergency room.

详细描述

In the United States (U.S.), death by suicide is a notable public health concern and a particular problem in the U.S. Veteran population. Furthermore, U.S. Veterans who live in rural areas may be at even greater risk for suicide than their urban counterparts. These risks may be concentrated during times of transition in their treatment such as after emergency room discharge. Multiple interventions have been developed to target suicide risk during periods of transition but there is limited evidence regarding their efficacy in preventing suicide. Furthermore, a key contributor to suicide risk may include limited or no engagement in care. Therefore, developing interventions to support engagement in treatment may be effective ways to help mitigate suicide risk and promote participation in care. This clinical trial studies an intervention that is designed to help support treatment engagement during periods of high risk in Veterans who live in rural areas. The trial will recruit Veterans from various treatment settings such as the emergency room, residential drug treatment programs, primary care mental health clinics, and/or inpatient psychiatric units and follow them for a period of six months. The trial evaluates not only the effect of the intervention on suicidal behavior but also measures of engagement.

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

  • Inpatient psychiatric unit:
  • Per the unit psychiatrist, hospitalization was due to concerns about acute risk for self-harm including suicidal ideation, suicide attempt, and/or admitting provider deemed the patient was at imminent risk for self-harm
  • Be a Veteran eligible to receive VA services
  • Be able to speak English
  • Inpatient medical-surgical unit:
  • Received a mental health consultation during admission on the medical-surgical unit
  • Per the consult-liaison psychiatrist, patient was recently (within past three months of hospitalization) or is currently at risk for self-harm including suicidal ideation, suicide attempt, or self-harm
  • Be a Veteran eligible to receive VA services; be 18 years or older; be able to speak English
  • Residential Rehabilitation Center (RRC) program:
  • Per the RRC treatment team, patient was recently (within past three months of hospitalization) or is currently at risk for self-harm including suicidal ideation, suicide attempt, or self-harm
  • Be a Veteran eligible to receive VA services; be 18 years or older; be able to speak English
  • Primary Mental Health Clinic (PMHC):
  • The patient was recently seen for a new evaluation in the WRJ PMHC clinic or a local integrated care clinic that are part of the White River Junction VA Medical Center Catchment Area (i.e., Burlington, Littleton, Rutland, Bennington, Brattleboro, or Keene) by either the mental health nurse practitioner, the psychologist, the psychiatry resident or a psychiatric attending
  • The patient is currently at risk for self-harm including suicidal ideation of any severity, suicide attempt, or self-harm; This could have been identified based on a formal suicide assessment scale such as the Columbia Suicide Severity Rating Scale or by clinician assessment as documented in the intake note
  • Be a Veteran eligible to receive VA services; be 18 years or older; be able to speak English

排除标准

  • Unable to provide informed consent
  • Potentially vulnerable populations including prisoners, institutionalized patients, or involuntarily committed patients

结局指标

主要结局

The Beck Scale for Suicidal Ideation (BSS)

时间窗: Change from Baseline BSS at 1-, 3-, and 6-months

The BSS ranges from 0-38. While there is no established BSS cutoff score to classify suicide risk, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation and that a change of five points or more on the total BSS scores may be clinically relevant. Mean scores at baseline were calculated.

次要结局

  • Columbia Suicide Severity Rating Scale (C-SSRS)(Number of events according to the CSSR-S at 1-, 3-, and 6-months)
  • The Beck Scale for Hopelessness (BHS)(Change from Baseline BHS at 1-, 3-, and 6-months)
  • The Partners in Health Scale (PIH) (Self Management)(Change from Baseline PIH at 1-, 3-, and 6-months)
  • Multidimensional Scale of Perceived Social Support (MSPSS)(Change from Baseline MSPSS at 1-, 3-, and 6-months)
  • Interpersonal Needs Questionnaire 15: Perceived Burdensomeness (INQ-15 PB)(Change from Baseline INQ-15 PB at 1-, 3-, and 6-months)
  • The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB)(Baseline, 1-month, 3-month, 6-month)
  • App Engagement Scale (AES) - for Mobile Applications(Change in AES scores at 1- and 6-months)
  • Suicide-Related Coping Scale (SRCS)(Change from Baseline SRCS at 1-, 3-, and 6-months)

研究者

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

Brian Shiner

Staff Psychiatrist

White River Junction Veterans Affairs Medical Center

研究点 (2)

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