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临床试验/NCT01473771
NCT01473771已完成不适用

Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

National Center for Telehealth and Technology12 个研究点 分布在 2 个国家目标入组 1,319 人开始时间: 2011年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,319
试验地点
12
主要终点
Suicide Mortality Rates

研究概览

简要总结

The purpose of this multi-site randomized controlled trial is to determine if the Caring Letters intervention is effective in preventing suicide and suicidal behaviors among U.S. Service Members and Veterans. The primary aim of this project is determine whether caring communications following inpatient psychiatric treatment reduce suicide and self-inflicted injuries among U.S. military personnel and Veterans. The investigators will also explore treatment utilization by comparing the frequency of treatment visits after enrollment into the study. The following specific hypotheses will be tested:

Hypothesis 1: During a two year follow-up after the index hospital discharge, the frequency of suicide will be lower among participants in the Caring Letters group compared to those in the Usual Care group.

Hypothesis 2: The frequency of medically admitted self-inflicted injuries will also be lower in the Caring Letters group compared to the Usual Care group.

Hypothesis 3: The time to suicidal act, among those who do subsequently exhibit one, will be longer among participants in the Caring Letters group compared to the Usual Care group.

详细描述

This social/ behavioral study is a five year multi-site randomized controlled trial that will compare the Caring Letters intervention (with usual care) to usual care without the caring letters. Participants will be recruited from inpatient psychiatry units of collaborating military and Veterans Affairs (VA) sites and randomized to either a group that receives letters (Caring Letters group) or a group that does not receive letters (Usual Care group). The methodology of the intervention is updated with emails instead of postal letters. This study fills an important gap in the evidence base for the Caring Letter intervention through a methodologically rigorous research design.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current psychiatric inpatients
  • Possess an active email account
  • Informed consent
  • Active duty military, Veteran, Retiree, National Guard or Reserves status

排除标准

  • Not competent to consent
  • Adverse behavioral problems
  • The primary psychiatric nurse or attending psychiatrist considers that study to be clinically inappropriate
  • Currently under arrest/incarceration
  • Involuntary committed for psychiatric care status

研究组 & 干预措施

Caring Letter Condition (CL)

Experimental

In the Caring Letters (CL) group, participants will be emailed "letters" for two years on a planned schedule. The emailed letters are simple expressions of care and include standard contact information for available health care services.

干预措施: Caring Letter (email) (Behavioral)

Usual Care (UC)

No Intervention

The participants in the Usual Care (UC) group will not receive the emails.

结局指标

主要结局

Suicide Mortality Rates

时间窗: Study Completion (2 years)

Death Certificates as recorded in the Center for Disease Control (CDC's) National Death Index Plus(NDI-Plus) will be reviewed. The Social Security Administration Master Death File will also be used.

次要结局

  • Time to Suicidal Behavior(Study Completion (2 years))

研究者

发起方
National Center for Telehealth and Technology
申办方类型
Fed
责任方
Sponsor

研究点 (12)

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Caring Letters for Military Suicide Prevention | 临床试验