Neural Mechanisms and Predictors of an Ultra-Brief Suicide Prevention Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Frontolimbic neural circuit activation and connectivity
研究概览
简要总结
The current study is a clinical trial, meaning a research study in which human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related behavioral outcomes. Specifically, male and female adults with current suicidal intent will be randomly assigned to receive either a 1-hour session of crisis response planning (CRP) or a 1-hour session of standard crisis risk management (Treatment as Usual). The effects of both conditions on changes in emotion regulation, behavioral inhibition, stress reactivity, and suicide risk will be evaluated post-intervention and at six-month follow-up. Additional assessments of changes in mood and suicidality will be collected daily during the first 10-days following intervention, and then monthly for a duration of six months. A cohort of healthy controls is included in the study but are not randomized to either treatment condition. The investigators hypothesize the following: 1) A single session of CRP will acutely change suicide risk and 2) Individuals who receive CRP will show sustained improvements in measures of suicidality when compared to individuals who received the Treatment as Usual intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Generally medically and neurologically healthy
- •Age 18 years or older at the time of consent
- •Willing and able to give informed consent
- •Individuals in the acutely suicidal group: endorse current suicide intent as indicated by a total score of 5 or greater on the Beck's Scale for Suicidal Ideation.
排除标准
- •Medical or neurologic condition or neurocognitive dysfunction that would interfere with the study
- •Current or past manic/hypomanic episode, schizophrenia, or psychotic symptoms
- •Deafness in either ear
- •Currently pregnant or trying to become pregnant
- •Electroconvulsive therapy (ECT) within the past 6 months
- •Current moderate to severe substance use disorder
- •Lack of fluency in English
- •Positive alcohol breathalyzer test and/or acute drug intoxication the day of the fMRI scans
- •Unwilling or unable to sign the informed consent document
- •Under 18 years old at the time of enrollment
- •Traumatic brain injury from a suicide attempt or another event
- •Presence of ferrous-containing metals within the body
- •Inability to tolerate small, enclosed spaces without significant anxiety
- •Individuals enrolled as controls: no lifetime history of any DSM-5 disorder
- •Individuals enrolled as controls: no lifetime history of suicide ideation or intent
研究组 & 干预措施
Crisis Risk Counseling
The crisis risk counseling session will last between 30 minutes to 1-hour. It will occur face-to-face with a trained study therapist. It will include the following standard suicide intervention strategies: supportive listening, provision of crisis resources, and referral to a mental health professional (if not already established). The therapist will conduct a semi-structured suicide risk assessment interview, after which subjects will complete a self-guided safety plan worksheet. The worksheet takes approximately 10-minutes to complete and will be done independently.
干预措施: Crisis Risk Counseling (Behavioral)
Control
Individuals who have not experienced suicidal ideation will not complete a suicide intervention.
Crisis Response Planning (CRP)
The crisis response planning (CRP) session will last between 30 minutes to 1-hour. It will occur face-to-face with a trained study therapist. The CRP session involves the following standard suicide intervention strategies: supportive listening, provision of crisis resources, and referral to a mental health professional (if not already established). The CRP active component involves a collaborative process in which the therapist invites the patient to share the events, symptoms, and contextual factors leading up to and surrounding the participant's suicidal crisis. Next, the patient and therapist identify the patient's personal warning signs for an emotional crisis, self-management coping skills, patient's reasons for living, and sources of social support. These components are written, by the patient, on an index card. The index card serves as a concrete reference for patients in the real-world.
干预措施: Crisis Response Planning (Behavioral)
结局指标
主要结局
Frontolimbic neural circuit activation and connectivity
时间窗: Pre-treatment, Post-treatment, and 6-months follow-up.
Task-induced activity in frontolimbic neural circuits measured with fMRI. Core regions of interest are: ventral prefrontal cortex, dorsal prefrontal cortex, inferior frontal gyrus, insula, and dorsal anterior cingulate cortex.
Suicidality
时间窗: Pre-treatment, Post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.
Self-reported suicide ideation, intent, behaviors and urges will be repeatedly assessed throughout the protocol using the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R), Beck's Scale for Suicidal Ideation (SSI), Lethality Rating Scale, and Suicide Cognitions Scale - Revised (SCS-R).
次要结局
- Mood and psychiatric symptoms(Pre-treatment, Post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.)
- Markers of negative affectivity(Pre-treatment, Post-treatment, and 6-months follow-up.)
研究者
Stephanie M Gorka, PhD
Associate Professor
Ohio State University