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

April 9, 2026 updated by: Stockholm University

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 10691
        • Stockholm University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Smartphone-based psychodynamic therapy with AI support
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
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.
Experimental: Smartphone-based cognitive behavior therapy with AI support
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
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.
No Intervention: Waitlist
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (pre-randomization), weekly during the 4-week intervention, post-treatment at week 4, and 1-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 4 weeks, and 1 month
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.
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)
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.
Baseline, weekly during weeks 1 through 4 (Generalized Anxiety Disorder-2 short form), 4 weeks (full scale), and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stockholm University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Per Carlbring, PhD, Stockholm University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STePS-Ai

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The individual participant data (IPD) that will be shared (Figshare or OSF) include de-identified, participant-level data from all phases of the study. Specifically, this dataset will contain (limited) demographic information, screening results, baseline assessments, and all primary and secondary outcome measures as well as some treatment engagement data. Data will be stripped of any identifying information and aggregated where appropriate to ensure confidentiality and compliance with data protection regulations.

IPD Sharing Time Frame

Anticipated during 2025.

IPD Sharing Access Criteria

By visiting Figshare or OSF.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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