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Chatbot for Depression, Anxiety, and Eating Disorders

Primary Purpose

Depression, Anxiety, Eating Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therabot
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Anxiety Symptoms
    Anxiety symptoms will be measured with the GAD-IV.
    Depressive Symptoms
    Depressive symptoms will be measured with the PHQ-9.
    Eating Disorders Symptoms
    Eating Disorders symptoms will be measured with the EDE-QS.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 22, 2023
    Last Updated
    August 28, 2023
    Sponsor
    Dartmouth-Hitchcock Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06013137
    Brief Title
    Chatbot for Depression, Anxiety, and Eating Disorders
    Official Title
    Testing an Artificial Intelligence Chatbot for Mental Health
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dartmouth-Hitchcock Medical Center

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Anxiety, Eating Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    210 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Therabot
    Other Intervention Name(s)
    Artificial Intelligence Chatbot
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Anxiety Symptoms
    Description
    Anxiety symptoms will be measured with the GAD-IV.
    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.
    Title
    Depressive Symptoms
    Description
    Depressive symptoms will be measured with the PHQ-9.
    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.
    Title
    Eating Disorders Symptoms
    Description
    Eating Disorders symptoms will be measured with the EDE-QS.
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nicholas C Jacobson, PhD
    Phone
    +1(603)-646-7015
    Email
    nicholas.c.jacobson@dartmouth.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sukanya Bhattacharya
    Phone
    603-646-6306
    Ext
    66306
    Email
    sukanya.bhattacharya.24@dartmouth.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nicholas C Jacobson, PhD
    Organizational Affiliation
    Dartmouth-Hitchcock Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Chatbot for Depression, Anxiety, and Eating Disorders

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