NCT07225192

Brief Summary

The investigators want to test if gen AI can support therapy by recruiting patients already in therapy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 3, 2025

Last Update Submit

November 17, 2025

Conditions

Generalized Anxiety Disorder (GAD)Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

  • Generalized Anxiety Disorder (GAD-7)

    Questions about symptoms of generalized anxiety disorder. Scale is 0-21. Higher scores is a worse outcome.

    Baseline, 4-week follow-up, 8-week follow-up

  • Patient Health Questionnaire (PHQ-9)

    Questions about symptoms of depression. Scale is 0-27. Higher score is a worse outcome.

    Baseline, 4-week follow-up, 8-week follow-up

Study Arms (2)

Chatbot Therapy Group

EXPERIMENTAL

Group 1 will be asked to use an AI chatbot like chatgpt as an adjunct to their regular therapy

Behavioral: Chatbot Therapy

Control

NO INTERVENTION

Group 2 will be asked to continue their regular therapy as usual.

Interventions

Chatbot TherapyBEHAVIORAL

This group will be asked to use an AI chatbot like chatgpt as an adjunct to their regular therapy

Chatbot Therapy Group

Eligibility Criteria

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

You may qualify if:

  • US Resident
  • English-speaking
  • Self-report having been treated for or diagnosed with generalized anxiety disorder or major depressive disorder by a licensed provider (e.g., MD, DO, LPCC, LCSW, LMFT) in the past 12 months
  • Self-report currently being in individual therapy

You may not qualify if:

  • Ever diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or hospitalized for suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Generalized Anxiety DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersDepressive DisorderMood Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Emergency Medicine and Informatics

Study Record Dates

First Submitted

November 3, 2025

First Posted

November 6, 2025

Study Start

November 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share