COVE (Caring for Vets and Service Members)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 521
- 试验地点
- 2
- 主要终点
- Suicidal Ideation
研究概览
简要总结
The goal of this clinical trial is to study stressed or distressed veterans and service members. Researchers will compare Caring Contacts plus best available resources to best available resources alone to see if reduces distress and prevents thoughts of suicide.
详细描述
The objective of this study is to evaluate whether Caring Contacts via text message are beneficial to veterans and service members experiencing stress or distress. In the past, Caring Contacts interventions have focused on individuals who are already suicidal and not a more general population. In addition, a core objective of this study is to understand the mechanisms of action of Caring Contacts and thus has included an ecological momentary assessment (EMA) component that will allow us to determine when and how Caring Contacts is making an impact.
Study aims are to
Evaluate if stressed or distressed veterans receiving Caring Contacts are at greater or less risk of suicidal ideation or behavior as evidenced by:
Decreased mean and reduction in variability of indicators of suicide risk (motivation to live, passive ideation, active ideation, suicide intent, and urges to harm self) acquired during Ecological Momentary Assessment periods.
Reduced risk of suicidal ideation (HASS-I) and cognitions (SCS-R) during follow-up.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
All outcome measures are completed by the participant via online survey.
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
- •US service member or veteran
- •18 years or older
- •Lives in the United States
- •Stressed (recent separation from or in transition out of the military, unemployment, financial strain, unhoused, or suicide loss, etc.) or distressed (isolation, depression, substance use, loneliness, defeat, hopelessness, psychological pain, or suicidal ideation, etc.)
- •Willingness to be contacted periodically by text message and either email or postal mail
排除标准
- •- Unable to consent due to inability to understand the consent form due to cognitive limitations or insufficient English (as determined by inability to pass the consent quiz items)
结局指标
主要结局
Suicidal Ideation
时间窗: Baseline and 12 month follow-up
Harkavy-Asnis Suicide Scale (HASS-I), adapted version for study procedures. Min=0, max=60, higher scores indicate higher suicidal ideation.
Suicide risk Visual Analog Scales (VAS)
时间窗: 3 EMA assessments/day for 14 days at baseline; then either 3 EMA assessments/day for 7 days at 12 months OR 3 EMA assessments/day for 7 days/month for 12 months (depending on EMA condition)
Suicide risk indicators rated on Visual Analog Scales (VAS; 0-10) acquired during Ecological Momentary Assessment periods. Core constructs of suicide risk selected and worded to maximize face validity: motivation to live, passive ideation, active ideation, and urges for suicide. Higher scores indicate higher suicidal risk (motivation to live is reverse coded).
Suicide Cognitions
时间窗: Baseline and 12 month follow-up
Suicide Cognitions Scale - Revised, Min=16, max=80, higher scores indicate more suicidal cognitions.
次要结局
- Loneliness(Baseline and 12 month follow-up)
- Substance Abuse(Baseline and 12 month follow-up)
- Psychological Pain(Baseline and 12 month follow-up)
- Defeat(Baseline and 12 month follow-up)
- Hopelessness(Baseline and 12 month follow-up)
- Experience of receiving Caring Contacts(12 month follow-up)
- Depression(Baseline and 12 month-up)
研究者
Kate Comtois
Professor: School of Medicine
University of Washington