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Chatbot for Depression, Anxiety, and Eating Disorders

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06013137
Collaborator
(none)
210
Enrollment
2
Arms
15
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Therabot
 N/A

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, EDE-QS, and general satisfactory questionnaires.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Testing an Artificial Intelligence Chatbot for Mental Health
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
Nov 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

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.

Other: Therabot
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:
  • Artificial Intelligence Chatbot

    		•
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Anxiety Symptoms [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.

    2. Depressive Symptoms [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.

    3. Eating Disorders Symptoms [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 EDE-QS.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Dartmouth-Hitchcock Medical Center

    Investigators

    • Principal Investigator: Nicholas C Jacobson, PhD, Dartmouth-Hitchcock Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicholas C. Jacobson, Dr. Nicholas Jacobson, Dartmouth-Hitchcock Medical Center
    ClinicalTrials.gov Identifier:
    NCT06013137
    Other Study ID Numbers:
    • 02000591
    First Posted:
    Aug 28, 2023
    Last Update Posted:
    Aug 30, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Feeding and Eating Disorders

    Study Results

    No Results Posted as of Aug 30, 2023