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Therapy and Tech Study

Therapy and Tech Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07225192
Enrollment
204
Registered
2025-11-06
Start date
2025-11-30
Completion date
2026-01-31
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder (GAD), Major Depressive Disorder

Brief summary

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

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.

Interventions

BEHAVIORALChatbot Therapy

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

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Generalized Anxiety Disorder (GAD-7)Baseline, 4-week follow-up, 8-week follow-upQuestions about symptoms of generalized anxiety disorder. Scale is 0-21. Higher scores is a worse outcome.
Patient Health Questionnaire (PHQ-9)Baseline, 4-week follow-up, 8-week follow-upQuestions about symptoms of depression. Scale is 0-27. Higher score is a worse outcome.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026