Digital Coach to Support Exposure Therapy Homework for Anxious Youth

NCT07666672 | Not Yet Recruiting

• 2 other identifiers: 2026P00086310.17605/OSF.IO/DCP4M
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Anxiety Disorders; OCD

Keywords

anxiety; exposure therapy; pediatric; large language model; conversational AI; randomized controlled trial

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Exposure-homework Adherence

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

Other Outcomes (14)

• Revised Children's Anxiety and Depression Scale (RCADS) - Total Anxiety (youth-report)

  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)

  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)

  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).

Study Arms (2)

BraveBot-Assisted Exposure

EXPERIMENTAL

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

Self-Guided Exposure

ACTIVE COMPARATOR

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

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.

Also known as: BraveBot by TheraLoop AI, Inc.

BraveBot-Assisted Exposure

Self-Guided Exposure Therapy Homework BEHAVIORAL

The youth completes the same clinician-assigned exposure independently, without BraveBot coaching (standard between-session homework).

Self-Guided Exposure

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Harvard University: collaborator
• Mclean Hospital: collaborator
• TheraLoop AI, Inc.: collaborator

Study Sites (3)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (8)

• 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

  BACKGROUND

• 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.

  PMID: 24135256 BACKGROUND

• 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.

  PMID: 29137655 BACKGROUND

• 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.

  PMID: 28221056 BACKGROUND

• 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.

  PMID: 19719351 BACKGROUND

• 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.

  PMID: 10937431 BACKGROUND

• Brooke, J. (1995). SUS: A quick and dirty usability scale. Usability Eval. Ind., 189.

  BACKGROUND

• 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.

  PMID: 41578705 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Madelaine R Abel, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua S Steinberg, MA

CONTACT

6179453115; jssteinberg@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Within-participant design. Each clinician-assigned, BraveBot-eligible exposure homework instance is individually randomized 1:1 at the moment of initiation to BraveBot-assisted vs self-guided completion; each youth therefore experiences both conditions and, theoretically, serves as their own control. That is, this is an instance-level, within-person randomized design rather than a fixed two-period crossover with washout.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 24, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)