跳至主要内容
临床试验/NCT06888141
NCT06888141招募中不适用

Virtual Intervention Targeting Distress in College Students: a Pilot Study

Boise State University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Change from baseline Patient Health Questionnaire-2 (PHQ-2) scores to 6wks post intervention

研究概览

简要总结

The goal of this clinical trial is to learn if a virtual task can reduce distress in college students. The main questions it aims to answer are:

  1. Will those who complete the virtual task have less distress?
  2. Will men and women both benefit equally from the virtual task?

Researchers will compare the virtual task to a control task (another virtual task that we expect will not impact distress) to see if distress differs.

Participants will spend 20 minutes engaging in the virtual task (or the control task) on 3 different days all within one week. They will complete a survey about their well-being before starting the first virtual task and again ~6 weeks afterward.

详细描述

Easily accessible and cost effective strategies for reducing emotional distress and improving stress tolerance in college students and the population generally are desired. The scalability and feasibility of virtual interventions hold promise for reaching segments of the population that find one-on-one psychotherapy aversive. Males in particular have higher perceived treatment stigma relative to women and find may typical traditional therapeutic processes incongruent with their masculine identity and values. The research team has designed an innovative, self-directed, virtual intervention to reduce distress and stress intolerance. The intervention consists of a set of virtual tasks which reflect the Sequential Model of Emotional Processing presented with language, imagery and content that engages men.

Using a randomized clinical trials design, this pilot project will compare the effects of the virtual intervention with a virtual control task on emotional well-being outcomes in college students.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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
是

入选标准

  • •18 years of age or older
  • •college student

排除标准

  • •Younger than 18 years of age

研究组 & 干预措施

Virtual Intervention

Experimental

干预措施: Virtual Sequential Emotional Processing Task (Behavioral)

Virtual Control

Sham Comparator

干预措施: Virtual Control Task (Behavioral)

结局指标

主要结局

Change from baseline Patient Health Questionnaire-2 (PHQ-2) scores to 6wks post intervention

时间窗: From enrollment to the end of the ~6wk follow up period.

The scale ranges from 0-6 where higher scores indicate more dysfunction.

次要结局

  • Change from baseline Generalized Anxiety Disorder-2 scores to 6wks post intervention(From enrollment to the end of the ~6wk follow up period.)
  • Change from baseline Connor-Davidson Resilience Scale-2 scores to 6wks post intervention(From enrollment to the end of the ~6wk follow up period.)

研究者

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

Matt Genuchi

Associate Professor

Boise State University

研究点 (1)

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