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Not yet recruiting NCT07225192

Therapy and Tech Study

No phase Interventional Generalized Anxiety Disorder (GAD) Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chatbot Therapy.
Who it may be relevant to
Registry conditions: Generalized Anxiety Disorder (GAD), Major Depressive Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • Generalized Anxiety Disorder (GAD-7) [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07225192 · STUDY00000488 · 4R33AT010606

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗