Digital Coach to Support Exposure Therapy Homework for Anxious Youth

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety Disorders; OCD
• Intervention / Treatment: Behavioral: BraveBot; Behavioral: Self-Guided Exposure Therapy Homework

Detailed Description

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).

Aims 3-5 (exploratory): preliminary effects on clinical outcomes (RCADS anxiety, CALIS-C life interference, IUSC intolerance of uncertainty) and associations with exposure-related processes; acceptability/usability/burden among youth, clinicians, and parents; and the performance and burden of BraveBot's automated risk-detection and clinician-notification (safety) workflow.

Participants and schedule. Up to 40 youth ages 12-22 with a clinical or subclinical anxiety or related disorder for which exposure-based CBT is indicated. BraveBot access remains active for up to 45 homework-reminder days (about six weeks), with a 12-week backstop (i.e., 84 calendar days). Standardized self-report measures are collected at baseline (pre-BraveBot), at the end of the active BraveBot period, and at a ~3-week follow-up. A separate population of up to 10 clinicians may voluntarily enroll to use the BraveBot system with their patients and complete surveys about their experience.

Analysis. Primary outcomes are analyzed with linear mixed-effects models (fixed effect of condition; random intercepts for youth, and clinician/site as needed), with Benjamini-Hochberg false-discovery-rate correction across the five co-primary outcomes. Adherence is analyzed with a binomial-logit generalized linear mixed-effects model.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua S Steinberg, MA; Phone Number: 6179453115; Email: jssteinberg@mgb.org

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital
      • Contact: Regina Meredith Elkins, PhD; Phone Number: 617-674-3557; Email: relkins@mgb.org
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Contact: Madelaine R Abel, PhD; Phone Number: 617-643-9435; Email: MABEL1@mgh.harvard.edu
    • Cambridge, Massachusetts, United States, 02138
      • Harvard University
      • Contact: John R Weisz, PhD, ABPP; Phone Number: 617-877-7716; Email: john_weisz@harvard.edu‬

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA (youth participants):

1. 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.
2. Between the ages of 12 and 22 years at the time of enrollment.
3. 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.
4. 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.
5. 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.

EXCLUSION CRITERIA (present at enrollment):

1. 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.
2. Youth is unable to complete homework independently.
3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: BraveBot; 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.; Other Names: BraveBot by TheraLoop AI, Inc.
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.	Behavioral: Self-Guided Exposure Therapy Homework; The youth completes the same clinician-assigned exposure independently, without BraveBot coaching (standard between-session homework).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Immediately after each completed, randomized exposure instance during the active BraveBot period (up to 45 homework-reminder days, or the 12-week backstop).
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).	Immediately after each completed, randomized exposure instance during the active BraveBot period (up to 45 homework-reminder days, or the 12-week backstop).
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).	Immediately after each completed, randomized exposure instance during the active BraveBot period (up to 45 homework-reminder days, or the 12-week backstop).
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).	Immediately after each completed, randomized exposure instance during the active BraveBot period (up to 45 homework-reminder days, or the 12-week backstop).
Exposure Quality -- Perceived Helpfulness (0-100)	Youth-reported helpfulness of the exposure in reducing anxiety, rated on a 0-100 slider after each completed randomized exposure instance. Minimum 0, maximum 100; higher scores indicate greater perceived helpfulness (better).	Immediately after each completed, randomized exposure instance during the active BraveBot period (up to 45 homework-reminder days, or the 12-week backstop).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For each randomized exposure instance during the active BraveBot period (up to 45 homework-reminder days, or the 12-week backstop).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).
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).	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).
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).	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).
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).	End of active BraveBot period (average of ~6 weeks, max of 12 weeks) and follow-up (3 weeks later).
Developmentally Adapted or Original Version of the System Usability Scale (SUS) (youth- and clinician-report)	Standardized usability measure of the BraveBot system (developmentally adapted for youth; standard version for clinicians). Score range 0-100; higher scores indicate better perceived usability (better).	End of active BraveBot period for youth (i.e., ~6 weeks on average, max of 12 weeks); end of study for clinicians (anticipated to be one year after recruitment begins).
Global Post-BraveBot Peference/Acceptability ratings (youth-report)	Youth-reported 0-100 slider ratings comparing BraveBot-assisted vs. self-guided exposure (e.g., effort, persistence, understanding, helpfulness, enjoyment, preference, future use, safety, willingness to recommend). Each item: minimum 0, maximum 100; higher scores indicate a more favorable rating of BraveBot.	End of active BraveBot period (i.e., ~6 weeks on average, max of 12 weeks).
Clinician Attitudes Toward AI	Clinician-reported AI-attitudes scale at orientation (items rated on 1-5 scale; total scores range from 7 to 35); higher scores indicate more favorable attitudes.	At baseline (orientation) and end of study (anticipated to be one year after recruitment begins)
Clinician Questionnaire - Global Feedback on BraveBot	0-100 global ratings of BraveBot's effects on exposure homework, workflow fit, acceptability, and clinical alignment, plus open-text feedback; higher scores indicate more favorable ratings.	End of study (anticipated to be one year after recruitment begins).
Novel Parent/Caregiver Perceptions of BraveBot Questionnaire	For parents/caregivers of youth participants under 18 years of age, 0-100 sliders comparing BraveBot-supported vs self-guided exposure homework (e.g., child willingness/engagement, persistence during distress, independence from parent, parent-child conflict/stress, structure/guidance, comfort/appropriateness, future preference, and concerns about AI).	At the end of the youth participant's active BraveBot period (i.e., ~6 weeks on average, max of 12 weeks).
Number of Automated Safety Alerts	Count of automated safety alerts generated by BraveBot's risk-detection workflow during BraveBot-assisted exposures. Reported as a count.	Throughout the active BraveBot period (i.e., average of 6 weeks; up to 12 weeks at most).
Clinician Response Time to Safety Alerts	Time from generation of an automated safety alert to documented clinician review, in hours. Reported as hours.	Throughout the active BraveBot period (i.e., average of 6 weeks; up to 12 weeks at most).
Proportion of Safety Alerts Classified as True Positive vs. False Positive	Among automated safety alerts reviewed by clinicians, the proportion classified as genuine concern (true positive) vs. false positive. Reported as a percentage.	Throughout the active BraveBot period (i.e., average of 6 weeks; up to 12 weeks at most).
Number of Clinician-Initiated Manual Safety Flags	Count of safety concerns flagged by clinicians that were not captured by the automated workflow (potential false negatives). Reported as a count.	Throughout the active BraveBot period (i.e., average of 6 weeks; up to 12 weeks at most).
Number of Youth-Reported "I Felt Unsafe" Responses	Count of post-exposure surveys on which a youth endorsed the "I felt unsafe" item. Reported as a count.	Throughout the active BraveBot period (i.e., average of 6 weeks; up to 12 weeks at most).

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Harvard University; Mclean Hospital; TheraLoop AI, Inc.
• Investigators: Principal Investigator: Madelaine R Abel, PhD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8.
• Lyneham HJ, Sburlati ES, Abbott MJ, Rapee RM, Hudson JL, Tolin DF, Carlson SE. Psychometric properties of the Child Anxiety Life Interference Scale (CALIS). J Anxiety Disord. 2013 Oct;27(7):711-9. doi: 10.1016/j.janxdis.2013.09.008. Epub 2013 Sep 26.
• Zieve, G. G., Dong, L., & Harvey, A. G. (2019). Patient Memory for Psychological Treatment Contents: Assessment, Intervention, and Future Directions for a Novel Transdiagnostic Mechanism of Change. Behaviour Change, 36(1), 1-11. https://doi.org/10.1017/bec.2019.1
• Harvey AG, Dong L, Lee JY, Gumport NB, Hollon SD, Rabe-Hesketh S, Hein K, Haman K, McNamara ME, Weaver C, Martinez A, Notsu H, Zieve G, Armstrong CC. Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial. Trials. 2017 Nov 14;18(1):539. doi: 10.1186/s13063-017-2276-x.
• Dong L, Lee JY, Harvey AG. Memory support strategies and bundles: A pathway to improving cognitive therapy for depression? J Consult Clin Psychol. 2017 Mar;85(3):187-199. doi: 10.1037/ccp0000167.
• Comer JS, Roy AK, Furr JM, Gotimer K, Beidas RS, Dugas MJ, Kendall PC. The intolerance of uncertainty scale for children: a psychometric evaluation. Psychol Assess. 2009 Sep;21(3):402-11. doi: 10.1037/a0016719.
• Brooke, J. (1995). SUS: A quick and dirty usability scale. Usability Eval. Ind., 189.
• Bekes V, Aafjes-van Doorn K. Who Wants to Have an AI Therapist? Acceptance of Using Artificial Intelligence for Mental Health Interventions Among Clinicians, Patients and the General Community. Clin Psychol Psychother. 2026 Jan-Feb;33(1):e70220. doi: 10.1002/cpp.70220.

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; pediatric; anxiety; exposure therapy; large language model; conversational AI
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2026P000863; 10.17605/OSF.IO/DCP4M (Other Identifier: Open Science Framework (OSF))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No routine sharing of individual participant data is planned at this time. De-identified, coded analytic datasets may be shared with named collaborators (Harvard University and TheraLoop AI, Inc.) under appropriate agreements and IRB approval. No deposit of individual-level data in public repositories is planned.

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No