[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07666672":3,"trial-entities:NCT07666672":153,"trial-summary:NCT07666672":160},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":49,"secondary_outcomes":66,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":15,"eligibility_criteria":74,"std_ages":78,"locations":81,"central_contacts":120,"overall_officials":125,"references":128,"see_also_links":152},"NCT07666672","2026P000863","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","NOT_YET_RECRUITING","2027-07-15","2026-06","2026-06-24","2026-07-15","Massachusetts General Hospital","OTHER",false,"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.\n\nRather 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).\n\nThe 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.\n\nBraveBot 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.","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.\n\nIntervention. 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.\n\nAims.\n\nAim 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).\n\nAim 2 (secondary): whether BraveBot increases exposure-homework ADHERENCE (probability that a randomized instance is completed).\n\nAims 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\u002Fusability\u002Fburden among youth, clinicians, and parents; and the performance and burden of BraveBot's automated risk-detection and clinician-notification (safety) workflow.\n\nParticipants 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.\n\nAnalysis. Primary outcomes are analyzed with linear mixed-effects models (fixed effect of condition; random intercepts for youth, and clinician\u002Fsite 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.",[19,20],"Anxiety Disorders","OCD",[22,23,24,25,26,27],"anxiety","exposure therapy","pediatric","large language model","conversational AI","randomized controlled trial","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},50,"ESTIMATED",[36,44],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"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.",[41],"BraveBot-Assisted Exposure",[43],"BraveBot by TheraLoop AI, Inc.",{"type":37,"name":45,"description":46,"armGroupLabels":47},"Self-Guided Exposure Therapy Homework","The youth completes the same clinician-assigned exposure independently, without BraveBot coaching (standard between-session homework).",[48],"Self-Guided Exposure",[50,54,57,60,63],{"measure":51,"description":52,"timeFrame":53},"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).",{"measure":55,"description":56,"timeFrame":53},"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).",{"measure":58,"description":59,"timeFrame":53},"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).",{"measure":61,"description":62,"timeFrame":53},"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).",{"measure":64,"description":65,"timeFrame":53},"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).",[67],{"measure":68,"description":69,"timeFrame":70},"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).","ALL","12 Years","22 Years",{"inclusion":75,"exclusion":76,"raw_text":77},[],[],"INCLUSION CRITERIA (youth participants):\n\n1. 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.\n2. Between the ages of 12 and 22 years at the time of enrollment.\n3. 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.\n4. Sufficient ability to communicate in English (study materials, measures, and the BraveBot interface are currently English-only). For minors, at least one parent\u002Fguardian must be sufficiently proficient in English to understand the consent information.\n5. The youth and\u002For 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.\n\nEXCLUSION CRITERIA (present at enrollment):\n\n1. 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\u002Fspecialized treatment such that exposure-based CBT for anxiety\u002FOCD is not the appropriate primary focus.\n2. Youth is unable to complete homework independently.\n3. 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.\n\nThe 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.",[79,80],"CHILD","ADULT",[82,97,108],{"facility":83,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":94},"McLean Hospital","Belmont","Massachusetts","02478","United States",[89],{"name":90,"role":91,"phone":92,"email":93},"Regina Meredith Elkins, PhD","CONTACT","617-674-3557","relkins@mgb.org",{"lat":95,"lon":96},42.39593,-71.17867,{"facility":13,"city":98,"state":85,"zip":99,"country":87,"contacts":100,"geoPoint":105},"Boston","02114",[101],{"name":102,"role":91,"phone":103,"email":104},"Madelaine R Abel, PhD","617-643-9435","MABEL1@mgh.harvard.edu",{"lat":106,"lon":107},42.35843,-71.05977,{"facility":109,"city":110,"state":85,"zip":111,"country":87,"contacts":112,"geoPoint":117},"Harvard University","Cambridge","02138",[113],{"name":114,"role":91,"phone":115,"email":116},"John R Weisz, PhD, ABPP","617-877-7716","john_weisz@harvard.edu‬",{"lat":118,"lon":119},42.3751,-71.10561,[121],{"name":122,"role":91,"phone":123,"email":124},"Joshua S Steinberg, MA","6179453115","jssteinberg@mgb.org",[126],{"name":102,"affiliation":13,"role":127},"PRINCIPAL_INVESTIGATOR",[129,132,135,138,141,144,147,149],{"type":130,"citation":131},"BACKGROUND","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:\u002F\u002Fdoi.org\u002F10.1017\u002Fbec.2019.1",{"pmid":133,"type":130,"citation":134},"24135256","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\u002Fj.janxdis.2013.09.008. Epub 2013 Sep 26.",{"pmid":136,"type":130,"citation":137},"29137655","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\u002Fs13063-017-2276-x.",{"pmid":139,"type":130,"citation":140},"28221056","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\u002Fccp0000167.",{"pmid":142,"type":130,"citation":143},"19719351","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\u002Fa0016719.",{"pmid":145,"type":130,"citation":146},"10937431","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\u002Fs0005-7967(99)00130-8.",{"type":130,"citation":148},"Brooke, J. (1995). SUS: A quick and dirty usability scale. Usability Eval. Ind., 189.",{"pmid":150,"type":130,"citation":151},"41578705","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\u002Fcpp.70220.",[],{"nct_id":4,"conditions":154,"biomarkers":159},[155,156,157,158],"Anxiety Disorder","Obsessive Compulsive Disorder","Panic Disorder","Social Anxiety Disorder",[],{"nct_id":4,"found":161,"summary":162,"prompt_version":171},true,{"design":163,"status":164,"heading":6,"summary":165,"follow_up":166,"word_count":167,"commitments":168,"compensation":169,"drugs_mentioned":170},"This is an open-label study where each individual exposure homework assignment is randomly chosen to be done with BraveBot or on your own. It involves up to 50 participants.","completed","This study is testing a digital tool called BraveBot to help young people (ages 12-22) with anxiety disorders or OCD who are doing exposure therapy homework as part of their treatment. BraveBot is a computer program that talks with you through your phone or computer to support you during \"face-your-fears\" homework assigned by your therapist. Sometimes you'll do the homework with BraveBot's coaching, and sometimes on your own. The study will measure how well you understand the homework, how much effort you put in, and how capable you feel after each exposure. The study is currently unclear on its recruitment status and plans to enroll 50 participants.","Your responses will be measured immediately after each completed exposure instance during the active BraveBot period, which can last up to 45 homework-reminder days or 12 weeks.",107,"You will complete clinician-assigned exposure therapy homework, sometimes with BraveBot coaching and sometimes independently. After each exposure, you will answer a few short questions about how it went.","Not stated in the trial record.",[38],"v2"]