Effects of a Targeted Web-Based Suicide Prevention Intervention on Suicidal Ideation and Self-Directed Violence: A Randomized Controlled Trial in Veterans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Suicidal behaviors change
研究概览
简要总结
Suicide prevention is a top priority for VA as all continue to seek new and inventive ways to reduce suicide rates among Veterans. Many experts agree that suicide prevention efforts could be improved by making suicide-specific interventions easier to access. The current project aims to move toward that goal by testing a web-based suicide prevention intervention using an experimental design. The roughly 40-minute intervention aims to teach Veterans coping skills that are designed to ease the emotional distress that often comes with thoughts of suicide. The project will evaluate whether Veterans who receive this intervention report more improvement in suicidal thoughts and behaviors than Veterans who receive a standard course of health care visits. Suicidal thoughts and behaviors will be measured over the course of one month. The investigators hypothesize that Veterans who receive the intervention will report lower suicidal thoughts and behaviors than those who receive the standard course of health care.
详细描述
Approximately 100,000 United States Veterans have died by suicide since 2000, at age- and sex-adjusted rates which far outpace that of non-Veterans. Suicide prevention remains VA's highest priority while the investigators seek innovative, research driven approaches. Psychotherapeutic interventions for suicide prevention are one area for further innovation. Specifically, strategies from evidence-based interventions that directly address suicidality could be distilled into briefer, more scalable formats to expand access to suicide prevention interventions.
Most psychotherapies target syndromes that contribute to suicidality (e.g., depression), which is arguably inefficient for reducing suicidality. Instead, effective suicide prevention interventions should directly target mechanisms that contribute to the progression from suicidal thoughts to plans, preparations and attempts. One mechanism associated with change in suicidality is psychological inflexibility. In the context of suicide, psychological inflexibility reflects a tendency to view suicidal thoughts as distressing and problematic, resulting in struggles to eliminate them. Suicide prevention interventions may therefore be more effective if they provision adaptive skills for coping with the psychological burden of suicidal ideation (SI). Of the few existing interventions that take this approach, most are not accessible enough to adequately address the issue due to numerous barriers to mental health care. Structured web-based interventions that provision adaptive coping responses for SI present one opportunity to overcome these barriers and reduce suicidality.
Recognizing these limitations, the PI developed a brief suicide-specific intervention, Re-Evaluating Suicidal Thoughts (REST), which is designed to provision skills to improve psychological inflexibility in the context of SI. Preliminary data from two samples, both of which completed a single session of REST in the clinic, are promising.
The current proposal aims to build on that work by evaluating REST as an adjunctive suicide prevention intervention compared to treatment-as-usual (TAU) in a sample of Veterans. In this two-arm RCT, Veterans (N = 180) will be randomized (1:1) to complete REST + TAU or to maintain TAU-only. Psychological inflexibility will be indexed via self-report across five time-points (Day 1 Pre-Intervention, Day 1 Post-Intervention, Day 3, Week 1, and Week 2). Psychological inflexibility will be indexed via the Acceptance and Action Questionnaire for Suicidal Ideation (AAQ-SI). Clinical outcomes of suicidal ideation severity (self-report measurement) and self-directed violence behaviors (clinical interview) will also be measured at five time-points (Day 1 Pre-Intervention, Day 3, Week 1, Week 2, and Month 1). Suicidal ideation severity will be indexed via the Beck Scale for Suicide Ideation (BSS). Suicidal self-directed violence behaviors will be indexed via the Columbia Suicide Severity Rating Scale (C-SSRS) interview.
Aim 1. Evaluate the effect of REST on the putative therapeutic mechanism, psychological inflexibility. Hypothesis 1. Compared to TAU, REST will be associated with significant differences between conditions in psychological inflexibility at Week 2, controlling for baseline psychological inflexibility.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants are blind to condition randomization, as is the PI, who provides suicide risk assessments throughout the follow-up period.
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
- •18 years or older
- •Past two-week suicidal ideation as indicated by positive reply to C-SSRS questions ("Have you had any actual thoughts of killing yourself," or, "Have you been thinking about how you might do this?")
排除标准
- •Active psychosis
- •Unmedicated bipolar disorder
- •Instances in which a substance use disorder would indicate inpatient detoxification prior to engaging in other outpatient mental health interventions
结局指标
主要结局
Suicidal behaviors change
时间窗: Baseline and one month
Data sourced from the Columbia Suicide Severity Rating Scale clinical interview (C-SSRS). The presence or absence of five categories of suicidal behaviors is indicated on a dichotomous (Yes/No) scale. Categories include: (1) Preparatory acts or behavior, (2) aborted attempt, (3) interrupted attempt, (4) actual attempt (non-fatal), and (5) completed suicide. Higher assigned score indicates greater severity of suicidal behavior.
Suicidal ideation severity change
时间窗: Baseline and one month
Data sourced from Beck Scale for Suicidal Ideation (BSS) self-report measure total score. BSS scores range from 0-38 on 19 items rated on a 0-2 scale. Higher scores indicate greater suicidal ideation severity.
Psychological inflexibility of suicidal ideation change
时间窗: Baseline and two weeks
Data sourced from Acceptance and Action Questionnaire for Suicidal Ideation (AAQ-SI) self-report measure total scores. AAQ-SI scores range from 4-28 on seven items rated on a 1-7 scale. Higher scores indicate greater experiential avoidance of suicidal ideation.
次要结局
未报告次要终点