[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603744":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":114,"collaborators":116,"id":123,"slug":26,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":26,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":26,"enrollmentInfo":131,"targetDuration":26,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":149,"whyStopped":26,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Toivoa Inc","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Toivoa-001 Digital CBT + NBHWC Coaching","ACTIVE_COMPARATOR","Participants in this arm receive a dual mental health treatment via a secure mobile app, including 8 psychoeducational modules and weekly one-on-one sessions with a National Board for Health \\& Wellness Coaching (NBHWC)-certified mental health coach. Modules focus on goal-setting, behavioral activation, cognitive restructuring, and interpersonal skill-building, with interactive exercises and opportunities for reinforcement. While the program is structured for one module per week over 8 consecutive weeks, participants may engage more flexibly in as little as 5-minute increments.\n\nALL INVITED PARTICIPANTS:\n\nFollowing baseline assessments, study participants will be randomized by the site administrator and then invited to join either the Toivoa-001 (therapy) or sham (control) through a meeting invitation. The invitation will include instructions to download and register for the app, and contact information for their coach or assessor.",[13],"Device: Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.",{"label":15,"type":16,"description":17,"interventionNames":18},"General Health Education + Interactive Quizzes","SHAM_COMPARATOR","Participants randomized to the sham comparator receive an 8-week digital program featuring general health and wellness information with interactive quizzes. This content is not related to anxiety treatment or CBT techniques. The arm is designed to mirror the Toivoa-001 arm in duration and engagement, ensuring parity in attention without therapeutic intent.",[19],"Device: Sham Digital Program - General health education and interactive quizzes unrelated to anxiety or CBT.",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Sham Digital Program - General health education and interactive quizzes unrelated to anxiety or CBT.","General health and wellness information with interactive quizzes. This content is not related to anxiety treatment or CBT techniques.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.","A dual mental health treatment consisting of digitally-administered Cognitive Behavioral Therapy combined with National Board Health and Wellness Coach (NBHWC) trained Mental Health Coaches",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Laura Randa","CONTACT","612-237-5896","lranda@toivoa.us",[38,64,82,98],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Delaware State University","Dover","Delaware","19904","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-75.52437,39.15817,{"lat":49,"lon":48},[52,56,60,62],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"Rosemarie White, DNP, CRNP-PMH, PMHNP-BC","302-760-1977","rawhite@desu.edu",{"name":57,"role":34,"phone":58,"phoneExt":26,"email":59},"Gwendolyn Scott-Jones, PsyD","302-736-2364","gscottjones@desu.edu",{"name":57,"role":61,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":63,"role":61,"phone":26,"phoneExt":26,"email":26},"Rosemarie White, DNP",{"facility":65,"status":26,"city":66,"state":67,"zip":68,"country":43,"countryCode":44,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"New Jersey Department of Veterans Health","East Orange","New Jersey","07018",{"type":46,"coordinates":70},[71,72],-74.20487,40.76732,{"lat":72,"lon":71},[75,80],{"name":76,"role":34,"phone":77,"phoneExt":78,"email":79},"Carol M Gibson-Gill, MD, MSCS, VHA-CM","973-676-1000","201564","carol.gibson-gill@va.gov",{"name":81,"role":61,"phone":26,"phoneExt":26,"email":26},"Carol M Gibson-Gill, MD",{"facility":83,"status":26,"city":84,"state":85,"zip":86,"country":43,"countryCode":44,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Louis Stokes Cleveland VAMC","Cleveland","Ohio","44106",{"type":46,"coordinates":88},[89,90],-81.69541,41.4995,{"lat":90,"lon":89},[93,97],{"name":94,"role":34,"phone":95,"phoneExt":26,"email":96},"MaryAnn Richmond, MD","216-791-3800","maryann.richmond@va.gov",{"name":94,"role":61,"phone":26,"phoneExt":26,"email":26},{"facility":99,"status":26,"city":100,"state":101,"zip":102,"country":43,"countryCode":44,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"South Texas Veterans Health Care System","San Antonio","Texas","78229",{"type":46,"coordinates":104},[105,106],-98.49363,29.42412,{"lat":106,"lon":105},[109,113],{"name":110,"role":34,"phone":111,"phoneExt":26,"email":112},"Alicia A Swan, PhD","210-517-5541","alicia.swan@va.gov",{"name":110,"role":61,"phone":26,"phoneExt":26,"email":26},{"type":115,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[117,120,122],{"name":118,"class":119},"Delaware Health Empowerment","UNKNOWN",{"name":121,"class":119},"DelCare Health Solutions",{"name":39,"class":119},"100603744",false,"NCT07140497","Reduction of Anxiety in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching - A Randomized Clinical Trial","Reduction of Anxiety Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy (CBT) and National Board for Health and Wellness Coaching (NBHWC) Mental Health Coaches for People With Disabilities (RADD)","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Presence of self-reported hearing or mobility disability\n* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study\n* Males and females; Age 22 years and above\n* Score of 15 or higher on the HAM-A\n* Clinical diagnosis of anxiety based on DSM-5 diagnostic criteria\n* Willingness to adhere to the Toivoa-001 or sham regimen once per week, including scheduling and weekly meetings with coaches\n* Access to necessary resources for participating in a technology-based intervention (e.g., Android phone, iPhone, iPad, internet access)\n* Treatment stability (no changes in psychotropic medication or psychotherapy treatment in the 30 days prior to study entry)\n* Able to read and speak English fluently\n* Resident of the United States and living in the United States for the duration of the trial\n\nExclusion Criteria:\n\n* Medical diagnosis of psychotic disorder or bipolar disorder\n* Participation in another treatment trial at the time of study\n* Substance use disorder in the past 12 months (excluding tobacco)\n* Suicide attempt in the past year or elevated suicide risk other than passive ideation (i.e., endorsing items reflecting intent, identifying means, suicide planning, or suicide-related preparations)\n* Currently pregnant, breastfeeding, or planning to become pregnant during the treatment period","ALL","22 Years",{"count":132,"type":133},200,"ESTIMATED","INTERVENTIONAL",[136],"NA","The purpose of this study is to see if a mobile-delivered mental health program called Toivoa-001, which combines digital cognitive behavioral therapy (CBT) with personal mental health coaching, can effectively reduce anxiety in adults with hearing or mobility disabilities. The study aims to answer whether this dual-intervention digital service is more effective at lowering anxiety symptoms over an 8-week period than a \"sham\" digital program that is developed to look similar but does not contain active therapeutic content.\n\nThe investigators hypothesize that participants who use the Toivoa-001 program will show significantly greater reductions in anxiety compared to those using the sham program, and that these mental health benefits will last through a 12-week follow-up.\n\nAdults within the disability community frequently encounter unique environmental and societal barriers - such as limited physical accessibility, transportation challenges, and workplace inflexibility - that can directly drive or worsen anxiety. By offering a fully remote and accessible mobile tool, this study seeks to determine if a digital health service can deliver scalable, effective anxiety relief tailored to the lived experiences of people with disabilities.",[139,140,141],"Hearing Disability","Anxiety","Mobility Disability",[140,143,144,145,146,147,148],"Depression","People with Hearing or Mobility Disability","Accessible Health for People with Disabilities and Veterans","Cognitive Behavioral Therapy","Cognitive Behavioral Therapy with Coaches","Coaches","NOT_YET_RECRUITING","2026-06-30",{"date":152,"type":153},"2026-07-02","ACTUAL",{"date":155,"type":133},"2026-08",{"date":157,"type":133},"2027-03",{"name":5,"class":6},4]