Digital Coach to Support Exposure Therapy Homework for Anxious Youth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-22
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
BraveBot
BehavioralScope-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
BehavioralThe youth completes the same clinician-assigned exposure independently, without BraveBot coaching (standard between-session homework).
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: BraveBot-Assisted ExposureExperimental treatment 1 intervention
Group B: Self-Guided ExposureActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Exposure Quality -- Effort (0-100)
Youth-reported effort put into the exposure, rated on a 0-100 slider after each completed randomized exposure instance. Minimum 0, maximum 100; higher scores indicate greater effort (better).
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).2
Exposure Quality -- Perceived Capability (0-100)
Youth-reported sense of being capable to approach or handle anxiety-provoking situations, rated on a 0-100 slider after each completed randomized exposure instance. Minimum 0, maximum 100; higher scores indicate greater perceived capability (better).
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).3
Exposure Quality -- Understanding (0-100)
Youth-reported understanding of what to do and why during the exposure, rated on a 0-100 slider after each completed randomized exposure instance. Minimum 0, maximum 100; higher scores indicate greater understanding (better).
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).4
Exposure Quality -- Ability to Continue When Distressed (0-100)
Youth-reported ability to stay with the exposure when it was difficult or distressing, rated on a 0-100 slider after each completed randomized exposure instance. Minimum 0, maximum 100; higher scores indicate greater ability to continue (better).
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).Secondary outcomes
1
Exposure-homework Adherence
Proportion of randomized exposure instances classified as Complete (vs. Incomplete), compared between BraveBot-assisted and self-guided conditions. Completion is determined automatically from condition-specific workflow flags. Reported as a proportion (0-1); a higher completion proportion for BraveBot-assisted vs. self-guided is better.
Time frame
For each randomized exposure instance during the active BraveBot period (up to 45 homework-reminder days, or the 12-week backstop).Other outcomes
1
Revised Children's Anxiety and Depression Scale (RCADS) - Total Anxiety (youth-report)
Anxiety symptom measure; each item scored 0 (Never) to 3 (Always). The Total Anxiety score is the sum of the five anxiety subscales (separation anxiety, social phobia, generalized anxiety, panic, obsessive-compulsive). Total Anxiety score range 0-111; higher scores indicate greater anxiety symptoms (worse).
Time frame
Baseline, end of active BraveBot period (average of ~6 weeks, up to max of 12 weeks), and follow-up (3 weeks following end of active BraveBot period).2
Child Anxiety Life Interference Scale (CALIS) (youth-report)
Self-report measure of anxiety-related interference in the child's daily life. Each of the 8 items are rated on a 0-4 scale. Total score range 0-32; higher scores indicate greater anxiety-related life interference (worse).
Time frame
Baseline, end of active BraveBot period (average of ~6 weeks, up to max of 12 weeks), and follow-up (3 weeks following end of active BraveBot period).3
Intolerance of Uncertainty Scale-Child (IUSC) (youth-report)
Self-report measure of intolerance of uncertainty; items rated 1-5. Total score range 27-135; higher scores indicate greater intolerance of uncertainty (worse).
Time frame
Baseline, end of active BraveBot period (average of ~6 weeks, up to max of 12 weeks), and follow-up (3 weeks following end of active BraveBot period).4
Memory for Treatment Content (youth-report)
Vignette-based, multiple-choice assessment of memory for exposure-CBT principles, scored as proportion correct (0-100%); higher scores indicate better memory for treatment content (better).
Time frame
End of active BraveBot period (average of ~6 weeks, max of 12 weeks) and follow-up (3 weeks later).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Harvard University
Collaborator
Mclean Hospital
Collaborator
TheraLoop AI, Inc.
Collaborator
Source ClinicalTrials.gov
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