Social Anxiety Disorder (SAD)STePS-AiNCT07533812
AI-Assisted 4-Week Psychodynamic Therapy and Cognitive Behavioral Therapy Via Smartphone for Social Anxiety: A Randomized Pilot Study (STePS-Ai)
A study testing Ai chatbot in people with Social Anxiety Disorder (SAD), run by Stockholm University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety Disorder (SAD)
- What is being tested?
- Ai chatbot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 21 Apr 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read the 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
- Social Anxiety Disorder (SAD)
- Being tested
- Ai chatbot
- Keywords
- STePS-Ai
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ai chatbotBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline, 4 weeks, and 1 month
Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: 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)
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.
Measured: Baseline, weekly during weeks 1 through 4 (Generalized Anxiety Disorder-2 short form), 4 weeks (full scale), and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start21 Apr 2025
- Primary completion21 Jun 2025
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety Disorder (SAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stockholm University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per Carlbring, PhD, Principal investigator, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533812
- Sponsor's protocol ID
- STePS-Ai
- Acronym
- STePS-Ai
- Status last verified
- Apr 2026
- First submitted
- 13 May 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07533812
- Acronym / sponsor ID
- STePS-Ai / STePS-Ai
- Conditions
- Social Anxiety Disorder (SAD)
- Keywords
- STePS-Ai
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 21 Jun 2025 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smartphone-based psychodynamic therapy with AI support | Experimental | Behavioral: Ai chatbotThis 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. |
| Smartphone-based cognitive behavior therapy with AI support | Experimental | Behavioral: Ai chatbotThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ai 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. | Behavioural | Smartphone-based cognitive behavior therapy with AI support, Smartphone-based psychodynamic therapy with AI support |
Primary outcome
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.
3 secondary outcomes
Liebowitz Social Anxiety Scale Self-Report (LSAS-SR)
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Carlbring, PhD principal investigator
Stockholm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ai chatbot in people with Social Anxiety Disorder (SAD), run by Stockholm University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.