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临床试验/NCT06019299
NCT06019299已完成不适用

Cluster-randomized Controlled Trial Examining the Effectiveness of Mindfulness-Based Cognitive Therapy for Anxiety and Stress Reduction Within College Students

Michigan State University1 个研究点 分布在 1 个国家目标入组 289 人开始时间: 2023年3月21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
289
试验地点
1
主要终点
Perceived Stress Scale

研究概览

简要总结

To understand the potential effectiveness of a 4 week Mindfulness-Based Cognitive Therapy intervention delivered using a smartphone application for reducing anxiety and stress within college students.

详细描述

The objective of this project is to understand the potential effectiveness of a 4 week Mindfulness-Based Cognitive Therapy intervention delivered using a smartphone application for reducing anxiety and stress within college students. Although in-person mindfulness-based cognitive therapy approaches have been found effective for reducing anxiety and stress; given the pervasiveness of anxiety and stress in this population, there is a need to provide alternative and accessible interventions to improve students' mental health. One such approach may be by leveraging existing tools such Sanvello - a free mindfulness-based cognitive therapy smartphone application - which could more easily be deployed across a broader population. Accordingly, using a cluster-randomized controlled design, this intervention will assess the extent to which 4-weeks of using the Sanvello application was effective for reducing anxiety and stress within 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
Treatment
盲法
None

入排标准

年龄范围
17 Years 至 42 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Enrolled in course

排除标准

  • •Complete inattendance in course during the pretest and study period.
  • •Opted out of data being available for research use

研究组 & 干预措施

Positive Control

Active Comparator

The control experimental group received training on the utilization of mindfulness-based stress reduction breathing techniques. Participants were instructed to set a timer for 5 minutes in order to engage in mindfulness breathing. Comprehensive instructions were provided during the initial laboratory time, elucidating the method by which participants were to direct their attention towards their breath. Moreover, participants were encouraged to cultivate a non-judgmental attitude when confronted with potential distractions and to subsequently redirect their focus back to their breathing. Participants were advised to integrate this technique into their daily lives as a means to alleviate anxiety and stress.

干预措施: Mindfulness Practice (Behavioral)

Mindfulness-Based Cognitive Therapy intervention

Experimental

The active experimental group received a mindfulness based cognitive therapy through the Sanvello smartphone application. Participants were encouraged to practice mindfulness daily through the application program "Braving Anxiety," which consisted of 35 modules. The anxiety management program consists of 1) Watch, 2) Read, 3) Listen, 4) Plan, 5) Listen - Mindfulness practice.

干预措施: Mindfulness Practice (Behavioral)

结局指标

主要结局

Perceived Stress Scale

时间窗: Change from baseline, 4 weeks.

The Perceived Stress Scale-4 as an index of perceived chronic stress levels. The possible scores range from 0 to 16, with higher scores indicating higher perceived chronic stress levels.

State-Trait Anxiety Inventory

时间窗: Change from baseline, 4 weeks.

Trait scale of the Spielberger State-Trait Inventory as an index of trait anxiety. The possible trait scores range from 20 to 80, with higher scores indicating greater levels of anxiety.

次要结局

未报告次要终点

研究者

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

Matthew B. Pontifex, Ph.D.

Professor of Kinesiology and Psychology

Michigan State University

研究点 (1)

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