Virtual Hope Box Enhanced Facilitation in High-Risk Suicidal Veterans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 928
- 试验地点
- 1
- 主要终点
- 6 month Suicide Behaviors (measured by the Columbia Suicide Severity Rating Scale [C-SSRS])
研究概览
简要总结
This study will test whether a novel intervention, Virtual Hope Box Enhanced Facilitation (VHB-EF), reduces suicide risk in Veterans after discharge from inpatient psychiatric hospitalization. Additionally, this study will also conduct interviews with Veterans and healthcare providers to explore barriers and facilitators to future adoption of the VHB-EF intervention in healthcare settings.
详细描述
The specific aims of this study are:
Aim 1: To evaluate the effects of VHB-EF for reducing suicide behaviors (primary outcome).
H1: Suicidal Veterans in the VHB-EF arm will be less likely to have suicide behaviors over the 6 months following enrollment compared to those in the EUC condition. The investigators will also examine the effects of VHB-EF on severity of suicidal ideation (secondary outcome).
Aim 2: Examine intervention mechanisms by measuring the effects of VHB-EF on potential mediators, 1) reasons for living, and 2) self-efficacy to (a) cope and (b) refrain from suicide attempts.
H2: VHB-EF Veterans will report higher levels of reasons for living and self-efficacy, compared to EUC. Exploratory sub-aim: The investigators will test the hypothesis that higher levels of reasons for living and self-efficacy will partially mediate the effect of VHB-EF on suicide behaviors over 6-months. Furthermore, the investigators will measure the effects of VHB-EF (vs. EUC) on depressive symptoms and healthcare utilization, and their potential role as mediators of outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Those enrolled in the RCT component of this study must be:
- •1) Veterans aged 18 or older
- •2) admitted to the inpatient psychiatric unit for a recent suicidal crisis
- •3) medically stable (the patient's medical and psychological fitness [including aggression] to provide informed consent will be determined by a member of the patient's treatment team)
- •4) A score of 3 or greater on the Callahan 6-item cognitive screening.
- •5) report current suicidal ideation (Scale for Suicidal Ideation [SSI]; sum of items 4 and 5 > 0, referencing the week prior to their hospitalization) as reported during the screening interview
- •6) no reported use of the VHB within the past 12-months
- •7) access to a smartphone to download the VHB app
排除标准
- •Veterans will be found ineligible for the program if:
- •1) do not understand English
- •2) are prisoners
- •3) are unable to provide informed consent
- •4) have profound psychotic symptoms and/or cognitive deficits that would prevent patients from understanding the content of the intervention and/or assessments
- •5) to not have access to a smartphone
研究组 & 干预措施
Virtual Hope Box Enhanced Facilitation (VHB-EF)
The VHB-EF intervention has two phases: (1) The in-person inpatient phase involves a single, one-on-one, 60-minute session delivered by the study interventionist prior to hospital discharge. During this session, the interventionist will obtain access to the participant's personal phone and assist them in downloading the VHB app. The interventionist will provide education about the app and personalized behavioral practice for each component of the app. They will also address strategies to enhance app use. In addition, participants will review a list of Veteran mental health resources, community services, Veteran service organizations, and other Veteran social support services available to Veterans in the area. (2) The remote-delivery phase builds on the work begun in the hospital via 2 follow-up phone contacts within 14 days following discharge, during which the study interventionist will monitor risk, review/revise VHB content, and support app use and outpatient treatment engagement.
干预措施: Virtual Hope Box Enhanced Facilitation (Behavioral)
Enhanced Usual Care (EUC)
The EUC condition will involve a one-on-one, 30-minute session delivered by the study interventionist prior to hospital discharge, during which the interventionist will review Veteran mental health resources, community services, Veteran service organizations, and other Veteran social support services available to Veterans in the area. The EUC session will remain focused only on reviewing the standardized list of Veteran and community services; no counseling will be provided, and the list provided by the study interventionist does not include non-services (i.e., does not list any smartphone applications, including the VHB app).
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
6 month Suicide Behaviors (measured by the Columbia Suicide Severity Rating Scale [C-SSRS])
时间窗: 6 months
Suicide behaviors will be measured by the C-SSRS and will be administered as a semi-structured interview. The definition of suicide behaviors for the primary outcome will consist of any actual suicide attempt or interrupted suicide attempt or aborted suicide attempt during the specified time period.
次要结局
- 6 month Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Worst Point)(6 months)