Elomia - Digital Mental Health and Well-Being

NCT06725147 | Completed

• 1 other identifier: 857217
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptoms of Depression and Anxiety; Perceived Stress

Keywords

Psychological Wellbeing; Digital Mental Health; Artificial Intelligence; College Students; Elomia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Behavioral: AI enabled wellness chatbot

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.

Behavioral: Penn Digital Wellness Resources

Interventions

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.

Elomia - Digital Mental Health Chatbot

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.

Penn Wellness Modules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \* 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Elomia company website

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Melissa G Hunt, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Clinical Training

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: January 15, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)