Anxiety DisordersNCT07666672
Digital Coach to Support Exposure Therapy Homework for Anxious Youth
A study testing BraveBot and Self-Guided Exposure Therapy Homework in people with Anxiety Disorders and OCD, run by Massachusetts General Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Anxiety Disorders, OCD
- What is being tested?
- BraveBot and Self-Guided Exposure Therapy Homework
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2027to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
McLean Hospital
Belmont, Massachusetts, 02478
Regina Meredith Elkins, PhD, 617-674-3557, relkins@mgb.org
Massachusetts General Hospital
Boston, Massachusetts, 02114
Madelaine R Abel, PhD, 617-643-9435, MABEL1@mgh.harvard.edu
Harvard University
Cambridge, Massachusetts, 02138
John R Weisz, PhD, ABPP, 617-877-7716, john_weisz@harvard.edu
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Anxiety Disorders, OCD
- Being tested
- BraveBot, Self-Guided Exposure Therapy Homework
- Keywords
- anxiety, exposure therapy, pediatric, large language model, conversational AI, randomized controlled trial
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BraveBotBehavioural
Also called BraveBot by TheraLoop AI, Inc.
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 HomeworkBehavioural
The youth completes the same clinician-assigned exposure independently, without BraveBot coaching (standard between-session homework).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-Guided Exposure Therapy Homework |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: For each randomized exposure instance during the active BraveBot period (up to 45 homework-reminder days, or the 12-week backstop).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Feb 2027 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, Mclean Hospital, TheraLoop AI, Inc.
- Responsible party
- Principal investigator, Madelaine R. Abel, PhD, Massachusetts General Hospital
- Investigators
- Madelaine R Abel, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666672
- Sponsor's protocol ID
- 2026P000863
- Other IDs
- 10.17605/OSF.IO/DCP4M
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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
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.
PubMed 24135256Harvey 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.
PubMed 29137655Dong 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.
PubMed 28221056Comer 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.
PubMed 19719351Chorpita 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.
PubMed 10937431Brooke, 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.
PubMed 41578705
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07666672
- Acronym / sponsor ID
- 2026P000863
- Conditions
- Anxiety Disorders, OCD
- Keywords
- anxiety, exposure therapy, pediatric, large language model, conversational AI, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Harvard University, Mclean Hospital, TheraLoop AI, Inc.
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| BraveBot-Assisted Exposure | Experimental | Behavioral: BraveBotExposure 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. |
| Self-Guided Exposure | Active comparator | Behavioral: Self-Guided Exposure Therapy HomeworkExposure 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. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BraveBotAlso: BraveBot by TheraLoop AI, Inc.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. | Behavioural | BraveBot-Assisted Exposure |
| Self-Guided Exposure Therapy HomeworkThe youth completes the same clinician-assigned exposure independently, without BraveBot coaching (standard between-session homework). | Behavioural | Self-Guided Exposure |
Primary outcome
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).
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).
Exposure Quality -- Perceived Capability (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).
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).
Exposure Quality -- Understanding (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).
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).
Exposure Quality -- Ability to Continue When Distressed (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).
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).
Exposure Quality -- Perceived Helpfulness (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).
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).
1 secondary outcome
Exposure-homework Adherence
Time frame: For each randomized exposure instance during the active BraveBot period (up to 45 homework-reminder days, or the 12-week backstop).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- BackgroundZieve, 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: PubMed 24135256Lyneham 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.
- Background: PubMed 29137655Harvey 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.
- Background: PubMed 28221056Dong 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.
- Background: PubMed 19719351Comer 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.
- Background: PubMed 10937431Chorpita 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.
- BackgroundBrooke, J. (1995). SUS: A quick and dirty usability scale. Usability Eval. Ind., 189.
- Background: PubMed 41578705Bekes 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Madelaine R Abel, PhD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BraveBot and Self-Guided Exposure Therapy Homework in people with Anxiety Disorders and OCD, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua S Steinberg, MA (6179453115, jssteinberg@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07666672, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.