Chatbot for Depression, Anxiety, and Eating Disorders

Depression Clinical Trial

Official title:

Testing an Artificial Intelligence Chatbot for Mental Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06013137
• Other study ID #: STUDY02000591
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Disorder
• Eating Disorders
• Feeding and Eating Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth College	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.