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临床试验/NCT05202756
NCT05202756已完成不适用

Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide

Butler Hospital2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年6月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Patient Satisfaction

研究概览

简要总结

The primary aim of the present study is leverage existing infrastructure to develop novel technological features for a novel personalized smartphone intervention system, called the Mobile Application to Prevent Suicide (MAPS), and to establish feasibility, acceptability, safety, and estimate key parameters for primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization), and target mechanisms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of suicidal ideation and/or suicidal behavior in the past month
  • Between the ages of 18 and 70
  • Able to read, write, and understand English well enough to complete study procedures
  • Owns a smartphone

排除标准

  • Current psychotic or manic symptoms severe enough to interfere with completion of study procedures

研究组 & 干预措施

Mobile Application to Prevent Suicide (MAPS)

Experimental

Participants receiving MAPS will receive the Safety Planning Intervention (SPI) which will be uploaded into the smartphone app. They will be prompted four times per day to complete a brief ecological momentary assessment "check-in" inquiring about their cognitions, affect, and behavior, including suicidal thoughts and behaviors. Based on these responses, they will be provided with coping strategies from their safety plans and from a database of coping strategies created by study staff. They will also have access to emergency phone numbers, the coping strategies database, and can communicate with their study clinician through a text-like interface in the app. They will receive this intervention for one month.

干预措施: Mobile Application to Prevent Suicide (MAPS) (Behavioral)

EMA Monitoring Only (EMO)

Active Comparator

Participants in this condition will receive the Safety Planning Intervention (SPI) and will receive ecological momentary assessment prompts on the same schedule as the MAPS condition. However, they will not have access to any other MAPS features.

干预措施: EMA Monitoring Only (Behavioral)

结局指标

主要结局

Patient Satisfaction

时间窗: 1 month

Measured using the Client Satisfaction Questionnaire, a self-report measure of satisfaction with treatment. Scores range from 8 to 32, with higher scores representing higher satisfaction.

Ecological Momentary Assessment (EMA) Adherence

时间窗: 4 weeks

Number of assessments completed out of total

Emergency Department Visits

时间窗: 6 months

Number of emergency department visits will be assessed using the Treatment History Interview and medical records review.

Acceptability of Research Procedures

时间窗: 1 month

Feedback on qualitative interview.

Acceptability of MAPS Intervention

时间窗: 1 month

Feedback on qualitative interview.

Acceptability of Research (Recruitment)

时间窗: Baseline

Measured by recruitment rate.

Acceptability of Research (Dropout)

时间窗: 6 months

Measured by dropout rate.

Satisfaction with MAPS Intervention

时间窗: 4 weeks

Measured by protocol completion rate.

Suicidal Ideation and Behavior

时间窗: 6 months

Will be assessed using the Columbia Suicide Severity Rating Scale, items from the Modified Scale for Suicidal Ideation, and ecological momentary assessment of suicidal ideation and behavior. The Columbia Suicide Severity Rating Scale can provide presence/absence of suicidal ideation and suicidal behavior, as well as a suicidal ideation score ranging from 0 to 5 with higher scores representing more severe ideation, and a suicidal ideation intensity rating from 0-25 with higher scores representing more intense ideation.

Rehospitalization

时间窗: 6 months

Number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review.

次要结局

  • Use of MAPS Intervention-delivered Coping Strategies (target mechanism)(4 weeks)
  • Self-Efficacy (target mechanism)(4 weeks)
  • Reduction of Negative Affect (target mechanism)(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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