Therapy and Tech Study

November 17, 2025 updated by: Sean D Young, University of California, Irvine
The investigators want to test if gen AI can support therapy by recruiting patients already in therapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Recent advancements in AI have led to chatbots, such as ChatGPT, capable of providing therapeutic responses. Early research evaluating chatbots' ability to provide relationship advice and single-session relationship interventions has showed that both laypeople and relationship therapists rate them high on attributes such as empathy and helpfulness. The investigators want to test if chatbots can be a good adjunct to traditional therapy. The investigators hypothesize that participants who regularly use a chatbot as an adjunct to traditional therapy will have better mental health outcomes. Participants will complete baseline, 4-week (post-intervention) and 4-week post-intervention measures and will be invited to gain their therapists ratings.

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18+
  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chatbot Therapy Group
Group 1 will be asked to use an AI chatbot like chatgpt as an adjunct to their regular therapy
Behavioral: Chatbot Therapy
This group will be asked to use an AI chatbot like chatgpt as an adjunct to their regular therapy
No Intervention: Control
Group 2 will be asked to continue their regular therapy as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder (GAD-7)
Time Frame: Baseline, 4-week follow-up, 8-week follow-up
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)
Time Frame: Baseline, 4-week follow-up, 8-week follow-up
Questions about symptoms of depression. Scale is 0-27. Higher score is a worse outcome.
Baseline, 4-week follow-up, 8-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

November 3, 2025

First Submitted That Met QC Criteria

November 3, 2025

First Posted (Estimated)

November 6, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000488
  • 4R33AT010606 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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