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OpenTrials
Completed

NCT Number: NCT06725147

Elomia - Digital Mental Health and Well-Being

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

AI enabled wellness chatbot

Behavioral

Elomia uses generative AI to respond to user input about psychological stress and distress. It was trained on the responses of real therapists with expertise in cognitive-behavioral therapy. It provides an array of wellness interventions including exercises for calming; • exercises for falling asleep; • grounding techniques; • exercises to reduce anxiety; • breathing exercises; • exercises to improve self-esteem.

Penn Digital Wellness Resources

Behavioral

This active control intervention consists of a variety of digital wellness and stress management resources that are freely available to all Penn students.

Primary outcomes

  1. Beck Depression Inventory

    Time frame: 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.

  2. GAD 7

    Time frame: 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.

  3. Perceived Stress Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Digital Mental Health and Well-Being

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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