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临床试验/NCT03579706
NCT03579706已完成不适用

Evaluation of a Brief, Online Intervention for Military Personnel

Florida State University2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年6月25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
180
试验地点
2
主要终点
Change in Anxiety Sensitivity

研究概览

简要总结

This randomized controlled trial will compare the effectiveness and acceptability of a computerized treatment targeting anxiety sensitivity compared to an active control: Physical Health Education Treatment (PHET) to determine efficacy among military personnel when delivered over the Internet.

Purpose: To investigate the efficacy and acceptability of a computerized stress sensitivity treatment delivered online among a population of U.S. military personnel.

详细描述

The objective of the current proposal is to evaluate the efficacy of the Cognitive Anxiety Sensitivity Treatment (CAST) program in an online RCT through Amazon's Mechanical Turk with Veterans and military personnel. The primary outcome variables will be traumatic stress, anxiety, and depressive symptoms. The study is being conducted at Florida State University.

Specific Aims: (1) Evaluate the efficacy of the CAST program delivered over the Internet among Veterans and military personnel; (2) Assess acceptability and usability of the CAST program delivered over the Internet without in person appointments; (3) Determine the feasibility of using Amazon's Mechanical Turk to recruit and conduct a fully online randomized controlled trial of a computerized treatment.

Veterans or active duty personnel (N = 100) who are at increased risk for mental health problems, as indicated by elevated anxiety sensitivity, will be recruited through Amazon's Mechanical Turk. Mechanical Turk is an online marketplace for individuals interested in completing computerized tasks, such as research surveys, for compensation. Participants will complete self-report symptom measures before and after the intervention as well as at a 4-month follow-up appointment. The intervention is a single session and lasts approximately 45 minutes. The intervention contains educational material to dispel commonly held false beliefs about the dangerousness of experiencing anxiety symptoms, for example elevated heart rate or a difficulty concentrating. Then participants are guided through an exercise designed to bring on these uncomfortable bodily sensations to help participants reduce the amount of distress these symptoms cause. Participants will also be asked to provide feedback related to acceptability and usability of the intervention.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants anonymously complete all online measures and the intervention without contact with study personnel. Participants are randomized to the active or control condition without being told which condition they are participating in.

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

  • at least 18 years of age
  • current or past member of the U.S. military
  • elevated anxiety sensitivity as indexed by ASI-3 cognitive concerns subscale

排除标准

  • 未提供

结局指标

主要结局

Change in Anxiety Sensitivity

时间窗: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU

The Anxiety Sensitivity Index - 3 (ASI-3; Taylor et al., 2007) is an 18-item self-report measure of AS. This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the original ASI provides. The measure has shown good psychometric properties (Taylor et al., 2007).

次要结局

  • Usability of the computerized intervention(Immediately post intervention)
  • Change in Depressive Symptoms Module (PHQ-9).(Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU)
  • Change in Post-Traumatic Stress Disorder Symptoms(Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU)
  • Change in Anxiety Symptoms(Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU)
  • Client Satisfaction(Immediately post intervention)

研究者

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

Norman Schmidt

Professor

Florida State University

研究点 (2)

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