跳至主要内容
临床试验/NCT03121742
NCT03121742撤回不适用

A Pilot Study of a Smartphone-based Intervention for Suicidal Inpatients

Rutgers, The State University of New Jersey0 个研究点开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Suicide attempts

研究概览

简要总结

Suicide is the most common form of deadly violence. Indeed, since more than 40,000 people die by suicide each year, people are 2.5 times more likely to die by their own hand than someone else's. The four weeks after discharge from inpatient care is an especially dangerous period in terms of suicide risk, possibly because of poor post-discharge treatment adherence and poor treatment efficacy during a suicide crisis. To reduce suicide risk both in general and during the post-discharge period, interventions are needed that (1) are easily adhered to and (2) are effective during a suicide crisis. The goal of the study is to pilot-test a suite of five smartphone-based ecological momentary interventions (EMI) that can be easily used during a suicide crisis. Two target hopelessness, two target loneliness, and one targets negative automatic thoughts associated with hopelessness and loneliness. Although these interventions are new to the study of suicide, they are all grounded in decades of empirical work and adapted from effective interventions in areas relating to suicide.

Participants will be 20 inpatients (n = 10 each in treatment as usual [TAU] plus intervention and TAU plus assessment [i.e., control] groups) from the Massachusetts General Hospital Inpatient Psychiatric Service. The investigators hypothesize that those in the TAU plus intervention group will have lower levels of suicidal ideation during the inpatient and post-discharge period than those in the TAU plus assessment group.

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
Single (Participant)

入排标准

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

入选标准

  • Inclusion criteria include a recent (i.e., was included as the reason for admission) suicide attempt or serious suicidal ideation (i.e., ideation with at least 50% intent, assessed through either an explicit mention in the intake summary of intent greater than 50% or through this intent being inferred by clinical staff or in the notes [for example, if the patient notes they wanted to die more than they did not want to die during the attempt or episode of suicidal ideation]), English fluency, and access to an internet-capable smartphone (e.g., iPhone or Android).

排除标准

  • Exclusion criteria include any factor that impairs the ability to effectively participate in the study (e.g., intellectual abilities that are too low to understand the study and/or consent process) or a diagnosis of any schizophrenia-spectrum or psychotic disorder.
  • Additionally, patients who are on involuntary hospitalization status will be excluded.

结局指标

主要结局

Suicide attempts

时间窗: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)

The occurrence of suicide attempts (present/absent) over the course of the study, as assessed by the self-report version of the Self-Injurious Thoughts and Behaviors Interview (SITBI), administered at the end of the study.

Momentary Suicidal Ideation

时间窗: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)

Suicidal ideation as assessed by the ecological momentary assessment/intervention using a three item assessment of suicidal ideation that assess: (1) the desire to die by suicide, (2) the intention to die by suicide, and (3) the ability to resist the urge to die by suicide. This assessment will be given at four random times per day, as well as any time the participant initiates the survey or assessment.

Suicidal ideation

时间窗: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)

The occurrence of suicidal ideation (present/absent) over the course of the study, as assessed by the self-report version of the Self-Injurious Thoughts and Behaviors Interview (SITBI), administered at the end of the study.

次要结局

  • Loneliness(Through study completion: ~35 days (7 days inpatient + 28 days post-discharge))
  • Hopelessness(Through study completion: ~35 days (7 days inpatient + 28 days post-discharge))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Evan M. Kleiman, Ph.D.

Research Associate

Harvard University

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