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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Social Phobia Inventory (SPIN)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Ai chatbot (Behavioral)
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.
干预措施: Ai chatbot (Behavioral)
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.
结局指标
主要结局
Social Phobia Inventory (SPIN)
时间窗: 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.
次要结局
- 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)