BraveBot for Anxiety Disorders

Not yet recruiting at 2 trial locations
JS
Overseen ByJoshua S Steinberg, MA
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital tool called BraveBot, designed to assist young people undergoing exposure therapy for anxiety, OCD, or related issues. BraveBot is a computer program that guides users through therapy homework, offering support and monitoring progress. The researchers aim to determine if BraveBot facilitates therapy task completion and boosts confidence in managing anxiety. Young people aged 12-22, already participating in exposure-based cognitive behavioral therapy (CBT) for anxiety or OCD at specific clinics, may be suitable for this study. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance therapy experiences for others in the future.

What prior data suggests that BraveBot is safe for young people using CBT for anxiety?

Research has shown that digital tools like BraveBot are generally safe for users. BraveBot aids in exposure therapy, a common treatment for anxiety disorders, by allowing users to confront their fears in a controlled environment. It does not replace a therapist but supports the therapy process, making it low-risk.

A clinician supervises BraveBot's use, adding an extra layer of safety. If the system detects concerning language during a session, BraveBot can pause and notify the therapist. This safety feature ensures users receive support throughout their therapy. While specific studies on BraveBot's negative effects are lacking, its use in existing therapy practices suggests it is well-tolerated.

Overall, digital tools for mental health have proven safe and helpful when used correctly. BraveBot is part of this promising trend, aiming to make therapy more engaging and effective.12345

Why are researchers excited about this trial?

Unlike traditional treatments for anxiety disorders, which often rely on medication or therapist-led exposure therapy, BraveBot offers a unique, tech-driven approach. BraveBot is a conversational assistant powered by advanced language models, providing real-time, structured coaching during exposure exercises. This innovative tool helps clarify tasks, encourages persistence, and prompts users about safety behaviors, enhancing the exposure experience. Researchers are excited about BraveBot because it could make therapy more accessible, consistent, and engaging, especially for young people who are comfortable with digital interactions.

What evidence suggests that BraveBot is effective for anxiety disorders?

Research has shown that digital tools like BraveBot, which assist with therapy homework, can reduce anxiety symptoms. In this trial, participants will join either the BraveBot-Assisted Exposure group or the Self-Guided Exposure group. A small study found that automated chatbots used for therapy effectively lower anxiety and improve well-being. Cognitive behavioral therapy (CBT) alone is already effective, with studies indicating it helps many people reduce anxiety. Adding tools like BraveBot could enhance these effects by providing real-time support during homework tasks. This support might help young people stay on track with their therapy and feel more confident in managing their anxiety.678910

Who Is on the Research Team?

MR

Madelaine R Abel, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for youth ages 12-22 who are getting therapy for anxiety, OCD, or related issues at outpatient clinics. Participants must be assigned exposure therapy homework by their therapist and use a phone or computer. The study excludes those not in this age range or not receiving such therapy.

Inclusion Criteria

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
I am receiving or about to start exposure-based CBT at an MGB outpatient program.
I can communicate in English, or my parent/guardian can if I am a minor.
See 2 more

Exclusion Criteria

Symptoms of suicidal or homicidal ideation, psychosis, or a non-anxiety-related primary mental health concern requiring treatment prior to exposure treatment
Current substance use or dependence requiring specialized or higher-level care before anxiety-focused exposure-based CBT
Current severe eating disorder requiring intensive/specialized treatment making exposure-based CBT inappropriate as primary focus
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active BraveBot Period

Participants engage in exposure-based CBT with BraveBot support for up to 45 homework-reminder days

6 weeks (average), up to 12 weeks
Ongoing virtual interactions with BraveBot

Follow-up

Participants are monitored for safety and effectiveness after the active BraveBot period

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BraveBot

Trial Overview

The study tests BraveBot, a digital coach that helps young people with their 'face-your-fears' exposure therapy homework. Each time they do an assignment, it's randomly decided if they'll get support from BraveBot or do it on their own. The goal is to see if BraveBot makes exposures easier and more effective.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: BraveBot-Assisted ExposureExperimental Treatment1 Intervention
Group II: Self-Guided ExposureActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Harvard University

Collaborator

Trials
237
Recruited
588,000+

Mclean Hospital

Collaborator

Trials
221
Recruited
22,500+

TheraLoop AI, Inc.

Collaborator

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27775823/

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