NCT06013137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

August 22, 2023

Last Update Submit

June 24, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Anxiety 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

    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

    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.

Study Arms (2)

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

Control

NO INTERVENTION

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.

Interventions

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.

Also known as: Artificial Intelligence Chatbot
Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals currently being treated for active suicidality (measured with C-SSRS), Bipolar I/II, and active psychosis will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth College

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicholas C Jacobson, PhD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Nicholas Jacobson

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 28, 2023

Study Start

March 11, 2024

Primary Completion

May 18, 2024

Study Completion

August 30, 2024

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations