Digital Coach to Support Exposure Therapy Homework for Anxious Youth

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07666672
Status
Not Yet Recruiting

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Conditions

  • Anxiety Disorders
  • OCD

Eligibility Criteria

Sex
ALL
Age
12 Years - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • BraveBot — BEHAVIORAL
    Scope-limited, clinician-supervised, GPT-powered audio-to-audio conversational assistant delivered via a secure web link in SMS reminders. Supports clinician-assigned exposure homework by clarifying instructions and rationale, collecting SUDS, encouraging persistence, prompting about safety behaviors and white-knuckling, and guiding post-exposure reflection. Includes an automated risk-detection workflow that pauses the session, shows crisis resources, and notifies the treating clinician.
  • Self-Guided Exposure Therapy Homework — BEHAVIORAL
    The youth completes the same clinician-assigned exposure independently, without BraveBot coaching (standard between-session homework).

Study Details

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.

Key Dates

Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Jul 15, 2027
Completion
Jul 15, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: BraveBot-Assisted Exposure
    Exposure instances randomized to this condition are completed with BraveBot, an LLM-powered audio-to-audio conversational assistant that provides real-time, structured coaching: clarifying the assigned exposure and its rationale, collecting SUDS ratings, encouraging persistence, prompting about safety behaviors and 'white-knuckling' at mid-exposure check-ins, and guiding brief post-exposure reflection.
  • Active Comparator: Self-Guided Exposure
    Exposure instances randomized to this condition are completed independently by the youth (standard self-guided homework), without BraveBot coaching; the youth then completes the same brief post-exposure survey.

Primary Outcome Measure

Exposure Quality -- Effort (0-100) [ Time Frame: Immediately after each completed, randomized exposure instance during the active BraveBot period (up to 45 homework-reminder days, or the 12-week backstop). ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478
Regina Meredith Elkins, PhD
617-674-3557
Massachusetts General HospitalBostonMassachusetts02114
Madelaine R Abel, PhD
617-643-9435
Harvard UniversityCambridgeMassachusetts02138
John R Weisz, PhD, ABPP
617-877-7716

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