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临床试验/NCT04784663
NCT04784663已完成不适用

Public Messaging to Increase Treatment Seeking Among Veterans at Risk for Suicide During Transition From Military Service

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 355 人开始时间: 2022年12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
入组人数
355
试验地点
1
主要终点
Treatment Initiation

研究概览

简要总结

The risk for suicide increases by nearly 50% in the first year that service members transition from the military to civilian life underscoring the need for effective strategies to facilitate help seeking among Veterans vulnerable to self-directed violence. Yet despite a great need for treatment, more than half of returning Veterans at risk for suicide do not initiate mental health services. VA has embarked on the regular use of communication campaigns as part of a public health approach designed to reach the larger Veteran population with messages promoting help seeking. However, what types of messages effectively change beliefs and behaviors for at-risk Veterans resistant to seek treatment is unclear. The main objective of this study is to develop and test the use of public messaging to increase treatment seeking among Veterans at risk for suicide and resistant to seek mental health care following separation from military service. This represents the first study to systematically develop public messaging strategies for populations at risk for suicide.

详细描述

The main objective of this study is to develop and test the use of public messaging to increase treatment seeking among Veterans at risk for suicide and resistant to seek mental health care following separation from military service. A four-year mixed methods study that uses a sequential embedded design will be used to collect data from nationwide samples of Veterans at risk for suicide not in mental health treatment who separated from the DoD in the past year. Informed by the Theory of Planned Behavior, individual interviews will first be conducted to guide the design of effective public messages that will be subsequently tested in an RCT to determine exposure effects among targeted audience vs. waitlist control. Messages will be disseminated to study participants during the trial by a smartphone app. Research staff will collect assessments by telephone at baseline, 1- and 2-months post-randomization. Potential participants will primarily be identified using data available from the VA/DOD Identity Repository (VADIR) and recruited by invitational mailing and follow-up telephone calls. If the intervention is found effective, the investigators will work with the VA operational partner to include messages in future outreach approaches to prevent Veteran suicide and use findings to improve current communication performance measures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •U.S. Veteran that separated from military service in the past 36 months or less (any discharge type);
  • •>18 years old;
  • •experiencing suicide risk;
  • •low intent to seek help;
  • •capable of understanding the goals of the study;
  • •willing and able to provide verbal consent;
  • •smartphone ownership and willing to download/use study mobile app

排除标准

  • •currently (or in the past 12 months) in formal mental health treatment services;
  • •deemed impaired during eligibility screening;
  • •currently institutionalized

研究组 & 干预措施

Immediate Message Exposure

Experimental

Participants complete baseline (T1) and are randomly assigned to immediately receive 4 study videos over the first month. The exposure period ends and participants complete telephone-based assessments at 1- and 2-month follow up (T2 and T3 respectively). Study videos are delivered by study's mobile app downloaded to participants' own Smartphone.

干预措施: Messaging (Behavioral)

Wait List Control then message exposure at T2

Placebo Comparator

Participants complete baseline and are randomly assigned to the waitlist control. While wait-listed, participants will receive one push notification each week thanking them for participation, informing them that they will receive messages in the near future or reminding them of the length of the study.

Following the 1-month follow up (T2), they receive videos over a one month period. The exposure period ends and participants complete the 2-month follow up (T3) assessment by telephone.

Videos and push notifications are delivered by study's mobile app downloaded to participants' own Smartphone.

干预措施: Messaging (Behavioral)

Wait List Control then message exposure at T2

Placebo Comparator

Participants complete baseline and are randomly assigned to the waitlist control. While wait-listed, participants will receive one push notification each week thanking them for participation, informing them that they will receive messages in the near future or reminding them of the length of the study.

Following the 1-month follow up (T2), they receive videos over a one month period. The exposure period ends and participants complete the 2-month follow up (T3) assessment by telephone.

Videos and push notifications are delivered by study's mobile app downloaded to participants' own Smartphone.

干预措施: Wait list control (Other)

Wait List Control then message exposure at T3

Placebo Comparator

Participants complete baseline and are randomly assigned to the waitlist control. While wait-listed, participants will receive one push notification each week thanking them for participation, informing them that they will receive messages in the near future or reminding them of the length of the study.

Following completion of the 2 month follow-up (T3), participants receive videos over a one month period. They are not assessed post-exposure.

Videos and push notifications are delivered by study's mobile app downloaded to participants' own Smartphone.

干预措施: Wait list control (Other)

结局指标

主要结局

Treatment Initiation

时间窗: baseline through 2-month follow-up

yes to initiating psychological treatment and/or medication/pharmacological treatment in the past month to treat mental health issues.

次要结局

  • Mean Change in Beliefs About Mental Health Treatment(baseline through 2-month follow up)
  • Mean Change in Intentions to Seek Treatment(baseline through 2-month follow up)
  • Mean Change in Perceived Treatment Barriers(baseline through 2-month follow up)
  • Mean Change in Normative Beliefs About Seeking Mental Health Care(baseline through 2-month follow up)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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