Elomia - Digital Mental Health and Well-Being

NCT ID: NCT06725147

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2025-05-30

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.

Conditions

Symptoms of Depression and Anxiety; Perceived Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AI enabled wellness chatbot

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Penn Digital Wellness Resources

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Melissa Hunt, PhD

Associate Director of Clinical Training

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa G Hunt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

https://elomia.com/

Elomia company website

Other Identifiers

857217

Identifier Type: -

Identifier Source: org_study_id