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AI-Assisted 4-Week Psychodynamic and Cognitive Behavioral Therapy Via Smartphone for Social Anxiety: Randomized Pilot Study (STePS-Ai)

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Summary

NIH's ClinicalTrials.gov registered a new randomized pilot study comparing AI-assisted psychodynamic therapy and cognitive behavioral therapy delivered via smartphone for social anxiety disorder. The study will enroll participants in three arms: AI-guided psychodynamic therapy, AI-guided cognitive behavioral therapy, or waitlist control. Participants will complete weekly online questionnaires to monitor anxiety and mood changes over the 4-week intervention period.

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What changed

ClinicalTrials.gov registered a new pilot study (NCT07533812) evaluating two AI-assisted smartphone-based treatments for social anxiety disorder. The study compares psychodynamic therapy with AI chatbot support against cognitive behavioral therapy with AI chatbot support, with a waitlist control group. The AI assistant is designed to support participants in reflecting on therapeutic principles.

Healthcare providers and researchers monitoring digital mental health innovations should note this study as a registry entry for a novel AI-assisted therapeutic approach. The study has no stated compliance obligations and represents research registration activity rather than a regulatory action.

Archived snapshot

Apr 16, 2026

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← ClinicalTrials.gov Studies

AI-Assisted 4-Week Psychodynamic Therapy and Cognitive Behavioral Therapy Via Smartphone for Social Anxiety: A Randomized Pilot Study (STePS-Ai)

N/A NCT07533812 Kind: NA Apr 16, 2026

Abstract

This pilot study compares two 4-week, smartphone-based treatments for social anxiety: one uses a psychodynamic therapy approach and the other uses a cognitive behavioral therapy approach. Both treatments are guided by an AI assistant rather than a human therapist. The AI assistant is programmed to support participants in reflecting on core therapeutic principles, much like a well-informed coach would.

Participants are randomly assigned to one of three groups: psychodynamic therapy with AI support, cognitive behavioral therapy with AI support, or a waitlist control. Those in the waitlist group can receive an active treatment after the 4-week waiting period. All participants complete weekly online questionnaires to monitor anxiety and any changes in mood or well-being.

Conditions: Social Anxiety Disorder (SAD)

Interventions: Ai chatbot

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Named provisions

AI chatbot Social Anxiety Disorder (SAD) Psychodynamic therapy Cognitive behavioral therapy

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07533812
Docket
NCT07533812

Who this affects

Applies to
Healthcare providers Clinical investigators Pharmaceutical companies
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Digital health research AI-assisted therapy
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Artificial Intelligence Medical Devices Public Health

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