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临床试验/NCT06725147
NCT06725147已完成不适用

Digital Mental Health and Well-Being

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2025年1月15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
63
试验地点
1
主要终点
Beck Depression Inventory

研究概览

简要总结

This study is testing the acceptability and efficacy of an AI enabled mental health chatbot (Elomia) as a resource of college student wellness.

详细描述

Elomia is a generative AI program that can respond to text users type in with unique responses that are designed to address therapeutic targets like stress, anxiety, procrastination, feeling overwhelmed and so on. Elomia was "trained" by real therapists with expertise in cognitive-behavioral therapy who responded to many different real people typing about their concerns. Thus, Elomia can suggest a number of different evidence based therapeutic strategies and can help the user process negative feelings, think through problems, plan solutions, and trouble shoot things that might get in the way of implementing those strategies. Elomia's arsenal includes:

  • exercises for calming;
  • exercises for falling asleep;
  • grounding techniques;
  • exercises to reduce anxiety;
  • breathing exercises;
  • exercises to improve self-esteem. The algorithm determines the user's need for one or another type of help while communicating with the chatbot and suggests an exercise to ease their emotional state. Elomia is not a substitute for professional care, and will detect when a person needs something more than a chatbot and will suggest connecting with other resources. More information about Elomia can be found via this website: https://elomia.com/

The ultimate goal of this study is to explore whether a mental health chatbot is acceptable and can improve symptoms of depression, anxiety, stress, and promote general psychological well-being in college students. The investigators will compare Elomia to a curated collection of digital wellness resources that are typically provided to students at our University.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

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

  • •Undergraduate student at the University of Pennsylvania.
  • •At least 18 years of age.

排除标准

  • •* Severe depression or suicidality as indicated by Beck Depression Inventory score of >= 30, and/or a score of 2 or 3 on the Item (the suicide item) of the Beck Depression Inventory

研究组 & 干预措施

Elomia - Digital Mental Health Chatbot

Experimental

Participants randomized to Elomia will be expected to use the intervention at least once per week (for around 30 minutes) but are encouraged to use as needed/wanted. Elomia is a generative AI program that can respond to text the user types in with unique responses that are designed to address therapeutic targets like stress, anxiety, procrastination, feeling overwhelmed and so on. Elomia was "trained" by real therapists with expertise in cognitive-behavioral therapy who responded to many different real people typing about their concerns. Thus, Elomia can suggest a number of different evidence based therapeutic strategies and can help the user process negative feelings, think through problems, plan solutions, and trouble shoot things that might get in the way of implementing those strategies.

干预措施: AI enabled wellness chatbot (Behavioral)

Penn Wellness Modules

Active Comparator

Participants randomized to the control condition will be expected to use the intervention at least once per week (for around 30 minutes) but are encouraged to use as needed/wanted. The control condition consists of a curated collection of digital wellness resources that are already available freely to Penn students, including tips on getting good sleep, learning center material on time management and procrastination, and so on. The resources will be accessed via a single website, but there is no interactive component.

干预措施: Penn Digital Wellness Resources (Behavioral)

结局指标

主要结局

Beck Depression Inventory

时间窗: Baseline and 4 week follow-up

Self-report inventory of depressive symptoms Scores range from 0 to 63. Higher scores indicate more severe (worse) depressive symptoms.

Perceived Stress Scale

时间窗: Baseline and 4 week follow-up

Self-report questionnaire of perceived stress. Scores range from 0 to 40. Higher scores indicate more severe (worse) perceived stress.

GAD 7

时间窗: Baseline and 4 week follow-up

Self-report inventory of symptoms of anxiety. Scores range from 0 to 21. Higher scores indicate more severe (worse) symptoms 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

Melissa Hunt, PhD

Associate Director of Clinical Training

University of Pennsylvania

研究点 (1)

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