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

NCT07533812 | Active Not Recruiting

• 1 other identifier: STePS-Ai
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Anxiety Disorder (SAD)

Keywords

STePS-Ai

Outcome Measures

Primary Outcomes (1)

• Social Phobia Inventory (SPIN)

  The Social Phobia Inventory (SPIN) is a 17-item self-report questionnaire that measures fear, avoidance and physiological symptoms of social anxiety. Each item is rated on a 5-point Likert scale (0 = "not at all" to 4 = "extremely"), yielding a total score range from 0 to 68. Higher scores indicate more severe social anxiety symptoms.

  Baseline (pre-randomization), weekly during the 4-week intervention, post-treatment at week 4, and 1-month follow-up

Secondary Outcomes (3)

• Liebowitz Social Anxiety Scale Self-Report (LSAS-SR)

  Baseline, 4 weeks, and 1 month

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, weekly during weeks 1 through 4 (Patient Health Questionnaire-2 short form), 4 weeks (full scale), and 1 month

• Generalized Anxiety Disorder-7 (GAD-7)

  Baseline, weekly during weeks 1 through 4 (Generalized Anxiety Disorder-2 short form), 4 weeks (full scale), and 1 month

Study Arms (3)

Smartphone-based psychodynamic therapy with AI support

EXPERIMENTAL

This arm features a 4-week smartphone-delivered psychodynamic therapy intervention guided by an AI assistant. Participants will access structured treatment modules that emphasize emotional awareness, reduction of avoidance behaviors, and enhancement of affect regulation in social contexts. The AI assistant provides real-time reflection prompts, motivational support, and automated feedback based on the established psychodynamic material, ensuring consistent engagement throughout the treatment period. Weekly assessments monitor symptom changes, with data collected to evaluate the intervention's effectiveness in reducing social anxiety.

Behavioral: Ai chatbot

Smartphone-based cognitive behavior therapy with AI support

EXPERIMENTAL

This arm features a 4-week smartphone-delivered cognitive behavioral therapy (CBT) intervention guided by an AI assistant. Participants will access structured treatment modules that focus on psychoeducation about anxiety, cognitive restructuring to challenge and modify unhelpful thoughts, behavioral exposure techniques, and behavioral experiments to reduce avoidance. The AI assistant provides real-time reflection prompts, task reminders, motivational support, and automated feedback based on established CBT protocols, ensuring consistent engagement throughout the treatment period. Weekly assessments will monitor symptom changes, with data collected to evaluate the intervention's effectiveness in reducing social anxiety.

Behavioral: Ai chatbot

Waitlist

NO INTERVENTION

This arm involves a waitlist control condition where participants do not receive an active intervention during the 4-week period. Instead, they complete the same weekly assessments used in the active treatment arms to monitor changes in social anxiety symptoms and overall well-being. After the study period, participants will be offered the option to choose one of the active treatment approaches if desired.

Interventions

Ai chatbot BEHAVIORAL

This 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.

Smartphone-based cognitive behavior therapy with AI support; Smartphone-based psychodynamic therapy with AI support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Age 18 years or older * Score of 30 or higher on the Liebowitz Social Anxiety Scale-Self Report (LSAS-SR) * Access to a smartphone * Ability to read and write Swedish * Currently engaged in psychological treatment * Severe depression (Patient Health Questionnaire-9 score 20 or higher) * Use of medication for anxiety or depression if there have been changes within the past 30 days * Suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stockholm University: lead

Study Sites (1)

Stockholm university

Stockholm, Stockholm County, 10691, Sweden

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Per Carlbring, PhD

  Stockholm University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: April 16, 2026
• Study Start: April 21, 2025
• Primary Completion: June 21, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Anticipated during 2025.
• Access Criteria: By visiting Figshare or OSF.

Locations

SE (1)