Randomized Controlled Trial of the BraveBot Intervention as an Adjunctive Treatment for Young People With Anxiety and Related Disorders Receiving Outpatient, Exposure-Based Cognitive Behavioral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 3
研究概览
简要总结
This study is testing a digital tool called BraveBot for young people who are receiving cognitive behavioral therapy (CBT) for anxiety, OCD, or related problems. BraveBot is a computer program, not a person. It talks with youth through their phone or computer while they do "face-your-fears"-style exposure therapy homework that their therapist has assigned. Sometimes an exposure is done with BraveBot's real-time coaching, and sometimes on their own; after each exposure, youth answer a few short questions about how it went.
Rather than dividing participants into separate groups, the study randomizes each individual exposure homework assignment. Every time a young person opens an eligible exposure, the system makes a 1:1 random assignment deciding whether that exposure is completed with BraveBot's support or independently (self-guided).
The main goal is to learn whether using BraveBot helps youth understand their exposure assignments better, put in more effort, stick with exposures when they are hard, feel more capable, and find exposures more helpful in "fighting back" against anxiety. The study also examines whether BraveBot increases the likelihood that assigned exposures are completed, and explores effects on anxiety symptoms and how safe, easy to use, and useful BraveBot feels for youth, their therapists, and parents.
BraveBot does not replace the therapist, diagnose, or design exposures; it only supports the homework the clinician has assigned, and is used under clinician oversight. A built-in safety system can detect possible risk-related language, pause the session, show crisis resources (such as 988), and notify the treating clinician. The study is conducted within routine outpatient psychology clinics at Mass General Brigham. Up to 40 youth ages 12-22 will take part.
详细描述
Design. Open-label, within-participant, exposure-instance-level randomized trial embedded in routine outpatient exposure-based CBT at Mass General Brigham clinics. The unit of randomization is the individual clinician-assigned, "BraveBot-eligible" exposure homework instance. Each time a youth opens the link for a BraveBot-eligible exposure delivered via SMS reminder, the backend system immediately randomizes that single instance 1:1 to BraveBot-assisted vs self-guided completion.
Intervention. BraveBot is a scope-limited, clinician-supervised, large language model (GPT)-powered audio-to-audio conversational assistant (provided by TheraLoop AI, Inc.) that supports completion of clinician-assigned exposure homework. For BraveBot-assisted instances it clarifies the assignment and rationale, collects Subjective Units of Distress (SUDS) ratings and expectations, encourages persistence when anxiety rises, prompts about safety behaviors and "white-knuckling" at mid-exposure check-ins, and guides brief end-of-exposure reflection. It does not diagnose, generate exposure hierarchies, or make treatment decisions. For self-guided instances, the youth completes the same assigned exposure independently and then completes the same post-exposure survey.
Aims.
Aim 1 (primary): whether BraveBot improves exposure-homework QUALITY, assessed by five youth-reported 0-100 ratings per completed instance (Effort, Perceived Capability, Understanding, Ability to Continue, Perceived Helpfulness).
Aim 2 (secondary): whether BraveBot increases exposure-homework ADHERENCE (probability that a randomized instance is completed).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label. Of note, treating clinicians cannot view the numeric 0-100 post-exposure quality ratings (Effort, Capability, Understanding, Ability to Continue, Helpfulness), which are stored separately and are accessible to study staff only; this is an information barrier for the primary outcomes rather than formal masking.
入排标准
- 年龄范围
- 12 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(youth participants):
- •Has a clinical or subclinical anxiety or related disorder (e.g., panic disorder, social anxiety disorder, obsessive-compulsive disorder) for which exposure-based CBT is indicated.
- •Between the ages of 12 and 22 years at the time of enrollment.
- •Is either (a) currently receiving exposure-based CBT (or CBT in which exposure-based content is expected to be a core component) at a participating MGB outpatient program, or (b) on the waitlist for a participating program and expected to initiate exposure-based CBT in the near future.
- •Sufficient ability to communicate in English (study materials, measures, and the BraveBot interface are currently English-only). For minors, at least one parent/guardian must be sufficiently proficient in English to understand the consent information.
- •The youth and/or caregiver has access to a device that can receive SMS text reminders and open secure web links to complete exposure homework and brief post-exposure surveys.
排除标准
- •(present at enrollment):
- •Symptoms of suicidal or homicidal ideation, psychosis, or a non-anxiety-related primary mental health concern (i.e., where treatment for a disorder other than anxiety is indicated prior to exposure treatment, or independent exposure homework is not clinically appropriate as determined by the treating clinician). Examples include: current substance use or dependence requiring specialized or higher-level care that must be addressed before or instead of anxiety-focused exposure-based CBT; and current eating disorder severe enough to require intensive/specialized treatment such that exposure-based CBT for anxiety/OCD is not the appropriate primary focus.
- •Youth is unable to complete homework independently.
- •Any other condition or circumstance for which treatment for another primary psychiatric condition is clearly indicated prior to anxiety-focused exposure-based CBT, or for which out-of-session exposure homework is considered unsafe or inappropriate.
- •The investigators will also recruit up to 10 clinicians at participating programs who may use the BraveBot system with their patients (who have enrolled in the study independently) and complete brief baseline and end-of-study surveys.
研究者
Madelaine R. Abel, PhD
Assistant Professor
Massachusetts General Hospital