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临床试验/NCT05486091
NCT05486091已完成不适用

A Feasibility Open Trial of App-Enhanced Brief CBT for Suicidal Inpatients

Hartford Hospital2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2022年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Suicidal Ideation 2 Months

研究概览

简要总结

The purpose of this study is to evaluate the feasibility of integrating Brief Cognitive-Behavioral Therapy (BCBT) counseling with a software application (app) to prevent future suicidal thoughts and behaviors.

详细描述

Participants will provide written informed consent. Participants will complete up to 4 sessions of BCBT (depending on length of stay) incorporating the use of a SmartPhone app. This study treatment will be completed in addition to usual care in an open trial design. Assessments will be completed at intake, discharge, and 1-, 2-, and 3-month follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • History of suicide attempt (lifetime) AND active ideation (with or without plan or intent) on admission
  • Own and have access to their phone (iPhone or Android with capability to download apps) during their inpatient stay
  • Ability to understand the nature of the study and provide written informed consent
  • Willing and able to provide at least two verifiable contacts for emergency or tracking purposes
  • Expected length of stay long enough to complete the entire treatment protocol

排除标准

  • Not fluent in English
  • Experiencing current mania or psychosis
  • Have lifetime history of schizophrenia spectrum disorder, intellectual disability, or organic brain illness
  • Inpatient treatment plan includes detox protocol or electroconvulsive therapy
  • Any other psychiatric or medical condition that in the investigator's opinion would preclude informed consent or participation in the trial

结局指标

主要结局

Suicidal Ideation 2 Months

时间窗: 2 months after discharge

The Adult Suicidal Ideation Questionnaire (ASIQ) assesses the frequency of suicidal ideation. The ASIQ contains 25 items rated on a 0-6 scale. Items are added together for a total score ranging from 0 to 150. Higher scores indicate more frequent suicidal ideation. Means and standard deviations of the total score will be reported utilizing all available data.

Suicidal Ideation 3 Months

时间窗: 3 months after discharge

The Adult Suicidal Ideation Questionnaire (ASIQ) assesses the frequency of suicidal ideation. The ASIQ contains 25 items rated on a 0-6 scale. Items are added together for a total score ranging from 0 to 150. Higher scores indicate more frequent suicidal ideation. Means and standard deviations of the total score will be reported utilizing all available data.

App Usability at Discharge

时间窗: Assessed at completion of inpatient treatment (average of 16 days from admission)

The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5, with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data.

Suicidal Ideation Baseline

时间窗: Baseline (before receiving BCBT intervention)

The Adult Suicidal Ideation Questionnaire (ASIQ) assesses the frequency of suicidal ideation. The ASIQ contains 25 items rated on a 0-6 scale. Items are added together for a total score ranging from 0 to 150. Higher scores indicate more frequent suicidal ideation. Means and standard deviations of the total score will be reported utilizing all available data.

Frequency of Suicide Attempts

时间窗: 3 months post-discharge from inpatient unit

Frequency (percentage) of participants who made a suicide attempt over the entire follow-up period

Client Satisfaction at Discharge

时间窗: Assessed at completion of inpatient treatment (average of 16 days from admission)

The Client Satisfaction Questionnaire (CSQ) contains 8 multiple choice items and assesses the acceptability and satisfaction of the study treatment. Items are rated from 1 to 4. Items are added together for a total score ranging from 8 to 32 with higher numbers representing greater satisfaction with the treatment. The mean and standard deviation for the CSQ total score will be reported utilizing all available data.

Suicidal Ideation at Discharge

时间窗: Assessed at completion of inpatient treatment (average of 16 days from admission)

The Adult Suicidal Ideation Questionnaire (ASIQ) assesses the frequency of suicidal ideation. The ASIQ contains 25 items rated on a 0-6 scale. Items are added together for a total score ranging from 0 to 150. Higher scores indicate more frequent suicidal ideation. Means and standard deviations of the total score will be reported utilizing all available data.

Suicidal Ideation 1 Month

时间窗: 1 month after discharge

The Adult Suicidal Ideation Questionnaire (ASIQ) assesses the frequency of suicidal ideation. The ASIQ contains 25 items rated on a 0-6 scale. Items are added together for a total score ranging from 0 to 150. Higher scores indicate more frequent suicidal ideation. Means and standard deviations of the total score will be reported utilizing all available data.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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