Elomia - Digital Mental Health and Well-Being

Not Applicable

• Conditions: Symptoms of Depression and Anxiety; Perceived Stress

• Registration Number: NCT06725147
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-10
• Study Start: 2025-01-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory	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	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	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States