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临床试验/NCT06095817
NCT06095817终止不适用

Continuity of Military Transition Study: Project VALOR

Cornell University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年6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
终止
入组人数
140
试验地点
1
主要终点
Change in Negative Emotional State -- Depression

研究概览

简要总结

This study will examine the efficacy of an internet-based brief intervention designed to reduce risky behavior veterans as the move into their second year post-Army. Up to 350 veterans drawn from The Network Study (Dept of Defense; Award number: W81XWH1920001) will be recruited with the intention of drawing a final sample of 300. Study participants will be randomly assigned to either the intervention or the control group, stratified by age and gender.

详细描述

The combination of alcohol use and negative emotional states is a particularly toxic combination for suicide risk. The current study examines changes in alcohol/drug use/misuse and depression as veterans transition further into their post-Army environment and offers a personalized internet-based brief intervention intended to prevent/reduce alcohol misuse and depression in this population.

The study's objectives are to empirically quantify the form of changes that occur with respect to alcohol use and depression as veterans move into their second year post-Army; to identify stable individual risk factors (e.g., personality, military experiences) and dynamic risk factors (e.g., changes in stressors and normative contexts over time) that may be associated with differential temporal patterns of suicide-related behavior (i.e., alcohol use/misuse) and cognition (i.e., depression); and lastly, to determine whether a simple, internet-delivered brief intervention shown can reduce risky behavior in the veteran population.

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 62 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Is US Army veteran who participated in The Network Study (Dept of Defense; Award number: W81XWH1920001)
  • •Seeks/engages in civilian employment
  • •Lives in US

排除标准

  • •Retired with no plans to seek civilian employment
  • •Living outside of the US
  • •Separated from the National Guard or Reserves

研究组 & 干预措施

Intervention Condition

Experimental

Participants assigned to the intervention condition will be invited to engage with an internet-based intervention at the start of the study (12 months following their separation)

  • Half of those in the intervention condition will have already received two prior IDBIs (as part of the DoD funded study) within the first 6 months of separation.
  • The other half of those in the intervention condition will have received no prior IDBIs.

干预措施: Internet Delivered Brief Intervention (IDBI) (Behavioral)

Control

No Intervention

The control group will not be offered this month-12 internet-based intervention.

  • Half of those in the control condition will have received two earlier IDBIs (as part of the DoD funded study) within the first 6 months of their separation.
  • The other half of those in the control condition will have received no prior IDBIs.

结局指标

主要结局

Change in Negative Emotional State -- Depression

时间窗: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army

The Patient Health Questionnaire (PHQ)-9

Change in Heavy Episodic Drinking

时间窗: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army

Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)

Change in Modal alcohol consumption

时间窗: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army

Daily Drinking Questionnaire (DDQ) (Collins, Parks, \& Marlatt, 1985)

次要结局

  • Change in Alcohol-related problems(Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army)
  • Change in Suicidal ideation(Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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