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Active Not RecruitingNCT07533812

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

Smartphone-Based Treatments for Social Anxiety With Artificial Intelligence Support: A Three-Arm Randomized Controlled Pilot Study Comparing Psychodynamic Therapy, Cognitive Behavioral Therapy, and Waitlist (STePS-Ai)

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
Stockholm University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

This study builds upon earlier findings from the STePS project by investigating the feasibility and effectiveness of two brief, smartphone-delivered treatments for social anxiety, delivered entirely through an AI-guided platform. The study is a randomized, controlled pilot trial with three arms. Two intervention groups receive a 4-week treatment via smartphone: one group receives a psychodynamic therapy approach and the other receives a cognitive behavioral therapy approach. In both treatments, the AI assistant prompts reflection and engagement with the therapeutic material instead of a traditional therapist. The third group serves as a waitlist control, with participants given the option to choose one of the active treatments after the study period.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAi chatbotThis intervention uses an AI-enabled chatbot within a smartphone app to deliver psychotherapy modules. The chatbot guides participants through the modules by providing reflective prompts, motivational support and automated reminders to enhance engagement. All communication is encrypted to protect privacy.

Timeline

Start date
2025-04-21
Primary completion
2025-06-21
Completion
2026-07-01
First posted
2026-04-16
Last updated
2026-04-16

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT07533812. Inclusion in this directory is not an endorsement.