- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06013137
Chatbot for Depression, Anxiety, and Eating Disorders
June 24, 2025 updated by: Nicholas C. Jacobson, Dartmouth-Hitchcock Medical Center
Testing an Artificial Intelligence Chatbot for Mental Health
The research team would like to test how efficacious an artificial intelligence chatbot is in delivering supportive behavioral interventions in populations with anxiety, depression, or eating concerns.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The research team has developed a deep learning-powered application that can provide support and therapeutic suggestions via natural dialogue.
The chatbot is designed to be highly scalable such that it could address access issues (to address the majority of persons who do not not have access to therapy).
Eventually, it is hoped this intervention can provide accessible therapy for those with anxiety, depression, and eating disorders, among other mental illnesses.
The chatbot has been trained with intervention-oriented text conversations written by research assistants, employing a variety of therapeutic techniques, including cognitive-behavioral therapy.
The research team hopes to test how well the chatbot can respond and aid those with mental health symptoms.
The chatbot's effectiveness will be monitored based on the participants' interactions with the chatbot, as well as the participants' scores on the PHQ-9, GAD-IV, SWED, and general satisfactory questionnaires.
Study Type
Interventional
Enrollment (Actual)
210
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03766
- Dartmouth College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- We will recruit participants online using Facebook, Google Ads, Reddit, MTurk, listservs, and other online platforms.
- These individuals must meet the criteria for anxiety, depression or disordered eating, according to the PHQ-9, GADQ-IV, and SWED 3.0.
Exclusion Criteria:
- Individuals currently being treated for active suicidality (measured with C-SSRS), Bipolar I/II, and active psychosis will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
This group will have access to the Therabot smartphone application.
They will interact with the generative chatbot daily to discuss their mental health.
Each participant in this group will have some benchmark symptoms of depression, anxiety, or eating disorders.
They will fill out questionnaires every 4 weeks to describe changes in symptoms.
|
The participants assigned to the experimental group will interact with an artificial intelligence therapy chatbot to alleviate symptoms associated with depression, anxiety, and eating disorders.
The control group will not have access to this smartphone chatbot app.
Other Names:
|
|
No Intervention: Control
This group will not have access to the Therabot App.
They will fill out questionnaires every 4 weeks to describe changes in symptoms.
Each participant in this group will have some benchmark symptoms of depression, anxiety, or eating disorders.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety Symptoms
Time Frame: Each participant in the anxiety cohort will fill out an anxiety questionnaire to establish baseline symptoms, and they will fill out this questionnaire again after 4 and 8 weeks of using the therapy chatbot to track changes in their symptoms.
|
Anxiety symptoms will be measured with the GAD-IV.
|
Each participant in the anxiety cohort will fill out an anxiety questionnaire to establish baseline symptoms, and they will fill out this questionnaire again after 4 and 8 weeks of using the therapy chatbot to track changes in their symptoms.
|
|
Depressive Symptoms
Time Frame: Each participant in the depression cohort will fill out a questionnaire to establish baseline symptoms, and they will fill out this questionnaire again after 4 and 8 weeks of using the therapy chatbot to track changes in their symptoms.
|
Depressive symptoms will be measured with the PHQ-9.
|
Each participant in the depression cohort will fill out a questionnaire to establish baseline symptoms, and they will fill out this questionnaire again after 4 and 8 weeks of using the therapy chatbot to track changes in their symptoms.
|
|
Eating Disorders Symptoms
Time Frame: Each participant in the eating disorders cohort will fill out a questionnaire to establish baseline symptoms, and they will fill out this questionnaire again after 4 and 8 weeks of using the therapy chatbot to track changes in their symptoms.
|
Eating Disorders symptoms will be measured with the SWED.
|
Each participant in the eating disorders cohort will fill out a questionnaire to establish baseline symptoms, and they will fill out this questionnaire again after 4 and 8 weeks of using the therapy chatbot to track changes in their symptoms.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicholas C Jacobson, PhD, Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2024
Primary Completion (Actual)
May 18, 2024
Study Completion (Actual)
August 30, 2024
Study Registration Dates
First Submitted
August 22, 2023
First Submitted That Met QC Criteria
August 22, 2023
First Posted (Actual)
August 28, 2023
Study Record Updates
Last Update Posted (Actual)
June 27, 2025
Last Update Submitted That Met QC Criteria
June 24, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY02000591
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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