Elomia - Digital Mental Health and Well-Being

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.

Study Overview

• Status: Completed
• Conditions: Perceived Stress; Symptoms of Depression and Anxiety
• Intervention / Treatment: Behavioral: AI enabled wellness chatbot; Behavioral: Penn Digital Wellness Resources

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elomia - Digital Mental Health Chatbot; 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.	Behavioral: AI enabled wellness chatbot; 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.
Active Comparator: Penn Wellness Modules; 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.	Behavioral: Penn Digital Wellness Resources; This active control intervention consists of a variety of digital wellness and stress management resources that are freely available to all Penn students.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory	Self-report inventory of depressive symptoms Scores range from 0 to 63. Higher scores indicate more severe (worse) depressive symptoms.	Baseline and 4 week follow-up
GAD 7	Self-report inventory of symptoms of anxiety. Scores range from 0 to 21. Higher scores indicate more severe (worse) symptoms of anxiety.	Baseline and 4 week follow-up
Perceived Stress Scale	Self-report questionnaire of perceived stress. Scores range from 0 to 40. Higher scores indicate more severe (worse) perceived stress.	Baseline and 4 week follow-up

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Melissa G Hunt, PhD, University of Pennsylvania

Publications and helpful links

Helpful Links

• Elomia company website

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Artificial Intelligence; College Students; Digital Mental Health; Psychological Wellbeing; Elomia
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 857217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect participant confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No