Clinical trial NCT06725147: Elomia - Digital Mental Health and Well-Being
Official title: Digital Mental Health and Well-Being
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Symptoms of Depression and Anxiety
Perceived Stress
Keywords: Psychological Wellbeing
Digital Mental Health
Artificial Intelligence
College Students
Elomia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: Baseline and 4 week follow-up
measure: GAD 7
timeFrame: Baseline and 4 week follow-up
measure: Perceived Stress Scale
timeFrame: Baseline and 4 week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Melissa G Hunt, PhD
role: PRINCIPAL_INVESTIGATOR
References: