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NCT Number: NCT07533812

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Social Anxiety Disorder (SAD) Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stockholm university

Stockholm, Stockholm County, 10691, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Social Phobia Inventory (SPIN)

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

    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.

Secondary outcomes

  1. Liebowitz Social Anxiety Scale Self-Report (LSAS-SR)

    Time frame: Baseline, 4 weeks, and 1 month

    The Liebowitz Social Anxiety Scale Self-Report (LSAS-SR) is a 24-item self-report instrument measuring the severity of social anxiety by assessing fear and avoidance across 24 social and performance situations. Total scores range from 0 to 144, with higher scores indicating greater social anxiety severity. It supplements the primary Social Phobia Inventory (SPIN) measure by providing additional insight into the participants' subjective experience of social anxiety and functional impairment.

  2. Patient Health Questionnaire-9 (PHQ-9)

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

    The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure assessing depressive symptom severity over the past two weeks. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. A 2-item short form (Patient Health Questionnaire-2) is administered weekly to monitor mood, while the full 9-item version is collected at baseline, 4 weeks, and 1 month. This measure captures any effects of the intervention on depressive symptoms alongside anxiety outcomes.

  3. Generalized Anxiety Disorder-7 (GAD-7)

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

    The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report scale assessing the severity of generalized anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating more severe anxiety. A 2-item short form (Generalized Anxiety Disorder-2) is administered weekly, while the full 7-item version is collected at baseline, 4 weeks, and 1 month. This measure evaluates treatment effects on overall anxiety alongside social anxiety symptoms.

Sponsors and collaborators

Lead sponsor

Stockholm University

Other

Registry information

Official study title

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)

Acronym: STePS-Ai

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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