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Therapy and Tech Study

NCT ID: NCT07225192

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-01-31

Brief Summary

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

Detailed Description

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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. We want to test if chatbots can be a good adjunct to traditional therapy. We hypothesize that those 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.

Conditions

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Generalized Anxiety Disorder (GAD) Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Chatbot Therapy Group

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

Group Type EXPERIMENTAL

Chatbot Therapy

Intervention Type BEHAVIORAL

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chatbot Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Sean D Young

Professor of Emergency Medicine and Informatics

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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4R33AT010606

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000488

Identifier Type: -

Identifier Source: org_study_id