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临床试验/NCT04129866
NCT04129866Unknown不适用

Mobile Interpretation Bias Modification Clinical Trial

University of Southern Mississippi1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2019年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
114
试验地点
1
主要终点
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale

研究概览

简要总结

The Mobile-Interpretation Bias Modification clinical trial aims to examine the efficacy of a brief mobile phone delivered interpretation bias modification to reduce anxiety sensitivity cognitive concerns and suicidal ideation in National Guard Personnel. The investigators propose a randomized controlled trial testing the efficacy, acceptability, and usability of M-IBM with a sample of 114 National Guardsmen with current suicidal ideation and elevated anxiety sensitivity cognitive concerns. Participants will complete assessments, receive assistance on installing M- IBM on their phone, complete an M-IBM intervention session, and complete post-intervention assessments. Baseline measures of psychopathology, and usability/acceptability of M-IBM will be obtained during the initial session. In addition, 1-month, and 3-month follow-ups would be scheduled to examine changes in psychopathology. The investigators hypothesize that those randomized to M-IBM will experience reductions in anxiety sensitivity cognitive concerns, suicidal ideation. In addition participants will find M-IBM acceptable and easy to use.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Elevated ASCC (>2) and include only Guard members who also have current SI (> 0) .
  • •Ownership of a smartphone

排除标准

  • •those determined by military or study personnel to be actively psychotic, manic, or imminently suicidal and in need of emergency services

研究组 & 干预措施

M-IBM

Experimental

M-IBM is based on a slightly modified version of the word sentence association paradigm focused on words and sentences related to common concerns among those with elevated anxiety sensitivity cognitive concerns (i.e., losing control of mental processes).

干预措施: M-IBM (Behavioral)

Control IBM

Placebo Comparator

Control-IBM is identical to M-IBM except that the sentence that follows the cue word is not related to an anxious-threat interpretation of the cue word.

干预措施: Control-IBM (Behavioral)

结局指标

主要结局

Anxiety Sensitivity Index-3 Cognitive Concerns Subscale

时间窗: 3 months post intervention

Range 0 - 24, Higher Scores mean more pathology

The Self-Injurious Thoughts and Behaviors Interview

时间窗: 3 months post intervention

Anxiety Sensitivity Index-3 Cognitive Concerns Subscale

时间窗: 30 minutes

Range 0 - 24, Higher Scores mean more pathology

Anxiety Sensitivity Index-3 Cognitive Concerns Subscale

时间窗: 1 month post intervention

Range 0 - 24, Higher Scores mean more pathology

The Self-Injurious Thoughts and Behaviors Interview

时间窗: 1 month post intervention

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 (1)

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