SBIR-STTR Award

Disseminable Evidence-Based Treatment for the Dental Office: Virtual Exposure Tools for Dental Fear - neVR Fear the Dentist
Award last edited on: 2/15/2024

Sponsored Program
STTR
Awarding Agency
NIH : NIDCR
Total Award Amount
$1,493,067
Award Phase
2
Solicitation Topic Code
121
Principal Investigator
Margo Adams Larsen

Company Information

Virtually Better Inc

2440 Lawrenceville Highway Suite 200
Decatur, GA 30033
   (404) 634-3400
   hodges@virtuallybetter.com
   www.virtuallybetter.com

Research Institution

New York University

Phase I

Contract Number: 1R42DE030040-01
Start Date: 6/3/2021    Completed: 5/31/2022
Phase I year
2021
Phase I Amount
$264,997
Each year over 20 million adults with moderate fear and over 14 million adults with severe fear visit the dentist. Because fear portends poor future oral health, patients with dental fear come to experience their worst fears: pain, surgical procedures, and the need for more frequent dental visits. Avoidance is the natural and reinforced response, ironically guaranteeing a repetition of the feared events. Breaking this cycle is the primary target of this proposal. Standard treatment - compassionate but ultimately counterproductive - includes anti-anxiety medication or more substantial anesthesia, which (a) does nothing to reduce subsequent anxiety or avoidance, (b) leads to continued dental problems, and (c) perpetuates the cycle of fear->avoidance->dental problems. Alternatively, cognitive-behavioral treatments (CBT) for dental fear have been developed, subjected to dozens of high-quality trials, and found to be efficacious. However, CBT has, almost exclusively, been offered only in a few specialty clinics worldwide associated with universities; there is no disseminable model for integrating CBT into the workflow of dental practices. To fill this gap, this Fast-Track STTR proposal describes plans for development and testing of a marketable product that can bring effective dental fear treatment to dental offices within the currently existing U.S. practice ecosystem. neVR Fear the DentistTM is a commercializable suite of self-administered eHealth tools to treat dental fear that can be implemented in private practice dental offices throughout the U.S. and is eminently scalable. neVR Fear the DentistTM comprises three major evidence-based interventions. First is a self-administered eHealth app for CBT/psychoeducation with exposure therapy - delivered via a mobile tablet - that can be used privately in waiting rooms. Second is a communication-eliciting intervention, in which the patient records a "Pre-Game Plan" - to be reviewed with the dental staff before dental services - comprising (1) pre-treatment fear levels, (2) the factor generating the most anxiety, (3) a stop-signal the patient will use to alert dentist, (4) things the dental team can do to maximize this patient's comfort, and (5) a self-generated anxiety management plan. All patients in the treatment group will receive the first two EBIs as a single intervention on the tablet. Third (for patients who are in the severe range) is a 1-hr virtual reality exposure treatment (VRET). VRET will allow us to provide CBT that can be self-administered within the normal operations of dentistry and will allow every dental practice to be a dental fear specialty clinic. Such an approach is necessary to shift clinical practice, as the nearly 200,000 U.S. dentists will only adopt an approach designed, from the bottom up, to fit both the busy-ness and business of 21st-century dental practices. The research component will use an adequately powered RCT to test both (a) the effectiveness of neVR Fear the DentistTM and, using the NIH's Experimental Medicine Approach to Behavioral Change model, (b) whether inhibitory learning is the mechanism through which it affects change.

Public Health Relevance Statement:
Project Narrative Dental fear negatively affects the health of over 53 million American adults. Standard dental treatment (anti-anxiety medication or anesthesia) is compassionate but maintains the cycle of fear and avoidance; psychological treatments are effective but are rarely available and not easily disseminated. We propose to develop and test a suite of self-administered eHealth tools (neVR Fear the DentistTM) to treat dental fear that can be implemented in private practice dental offices throughout the U.S. and is eminently scalable.

Project Terms:
Adult; 21+ years old; Adult Human; adulthood; Affect; Aftercare; After Care; After-Treatment; post treatment; Anesthesia procedures; Anesthesia; Anxiety; Appointment; Belief; Brain; Brain Nervous System; Encephalon; Cognitive Therapy; Cognition Therapy; Cognitive Psychotherapy; cognitive behavior intervention; cognitive behavior modification; cognitive behavior therapy; cognitive behavioral intervention; cognitive behavioral modification; cognitive behavioral therapy; cognitive behavioral treatment; Communication; Costs and Benefits; Dental Care; Dental Procedure; dental service; Dental Offices; Dental Staff; dental personnel; Dentistry; Dentists; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Environment; Fright; Fear; Focus Groups; Future; Dental General Practice; dental practice; Health; Learning; Longevity; Length of Life; life span; lifespan; Medicine; United States National Institutes of Health; NIH; National Institutes of Health; Oral health; dental health; Pain; Painful; Patients; Personal Satisfaction; well-being; wellbeing; Private Practice; Public Health; Quality of life; QOL; Race; Racial Group; Racial Stocks; Records; Research; Self Administration; Self-Administered; Signal Transduction; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Societies; medical specialties; Specialty; Tablets; Testing; Anti-Anxiety Agents; Anti-Anxiety Drugs; Anxiolytic Agents; Anxiolytics; Minor Tranquilizing Agents; antianxiety agent; antianxiety drugs; United States Dept. of Health and Human Services; Department of Health and Human Services; United States Department of Health and Human Services; Universities; Gender; Dental Anxiety; Dental Fear; Dental Phobia; Odontophobia; Businesses; Healthcare; health care; Mediating; Ecosystem; Ecologic Systems; Ecological Systems; base; Procedures; Phase; psychologic; psychological; Training; Dental; Individual; Development Plans; Ethnic Origin; Ethnicity; uptake; Randomized Controlled Trials; tool; sedation; Sedation procedure; Adopted; Severities; Event; Oral; Clinic; System; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Operative Surgical Procedures; Visit; preference; Surgeon; American; experience; expectation; Reporting; social; Modeling; psychoeducation; response; Intervention Strategies; interventional strategy; Intervention; Effectiveness; Preventive; Data; NIDCR; NIDR; National Institute of Dental Research; National Institute of Dental and Craniofacial Research; Small Business Technology Transfer Research; STTR; follow-up; Active Follow-up; active followup; follow up; followed up; followup; Behavioral; active control; Evidence based treatment; cost; virtual; design; designing; Outcome; innovation; innovate; innovative; Evidence based intervention; demographics; standard care; standard treatment; intervention effect; clinical practice; operation; eHealth; e-Health; anxiety management; treatment group; negative affect; negative affectivity; treatment services; virtual reality exposure; Immersion

Phase II

Contract Number: 4R42DE030040-02
Start Date: 6/3/2021    Completed: 8/31/2025
Phase II year
2022
(last award dollars: 2023)
Phase II Amount
$1,228,070

Each year over 20 million adults with moderate fear and over 14 million adults with severe fear visit the dentist. Because fear portends poor future oral health, patients with dental fear come to experience their worst fears: pain, surgical procedures, and the need for more frequent dental visits. Avoidance is the natural and reinforced response, ironically guaranteeing a repetition of the feared events. Breaking this cycle is the primary target of this proposal. Standard treatment - compassionate but ultimately counterproductive - includes anti-anxiety medication or more substantial anesthesia, which (a) does nothing to reduce subsequent anxiety or avoidance, (b) leads to continued dental problems, and (c) perpetuates the cycle of fear->avoidance->dental problems. Alternatively, cognitive-behavioral treatments (CBT) for dental fear have been developed, subjected to dozens of high-quality trials, and found to be efficacious. However, CBT has, almost exclusively, been offered only in a few specialty clinics worldwide associated with universities; there is no disseminable model for integrating CBT into the workflow of dental practices. To fill this gap, this Fast-Track STTR proposal describes plans for development and testing of a marketable product that can bring effective dental fear treatment to dental offices within the currently existing U.S. practice ecosystem. neVR Fear the DentistTM is a commercializable suite of self-administered eHealth tools to treat dental fear that can be implemented in private practice dental offices throughout the U.S. and is eminently scalable. neVR Fear the DentistTM comprises three major evidence-based interventions. First is a self-administered eHealth app for CBT/psychoeducation with exposure therapy - delivered via a mobile tablet - that can be used privately in waiting rooms. Second is a communication-eliciting intervention, in which the patient records a "Pre-Game Plan" - to be reviewed with the dental staff before dental services - comprising (1) pre-treatment fear levels, (2) the factor generating the most anxiety, (3) a stop-signal the patient will use to alert dentist, (4) things the dental team can do to maximize this patient's comfort, and (5) a self-generated anxiety management plan. All patients in the treatment group will receive the first two EBIs as a single intervention on the tablet. Third (for patients who are in the severe range) is a 1-hr virtual reality exposure treatment (VRET). VRET will allow us to provide CBT that can be self-administered within the normal operations of dentistry and will allow every dental practice to be a dental fear specialty clinic. Such an approach is necessary to shift clinical practice, as the nearly 200,000 U.S. dentists will only adopt an approach designed, from the bottom up, to fit both the busy-ness and business of 21st-century dental practices. The research component will use an adequately powered RCT to test both (a) the effectiveness of neVR Fear the DentistTM and, using the NIH's Experimental Medicine Approach to Behavioral Change model, (b) whether inhibitory learning is the mechanism through which it affects change.

Public Health Relevance Statement:
Project Narrative Dental fear negatively affects the health of over 53 million American adults. Standard dental treatment (anti-anxiety medication or anesthesia) is compassionate but maintains the cycle of fear and avoidance; psychological treatments are effective but are rarely available and not easily disseminated. We propose to develop and test a suite of self-administered eHealth tools (neVR Fear the DentistTM) to treat dental fear that can be implemented in private practice dental offices throughout the U.S. and is eminently scalable.

Project Terms:
Adult; 21+ years old; Adult Human; adulthood; Affect; Aftercare; After Care; After-Treatment; post treatment; Anesthesia procedures; Anesthesia; Anxiety; Appointment; Belief; Brain; Brain Nervous System; Encephalon; Cognitive Therapy; Cognition Therapy; Cognitive Psychotherapy; cognitive behavior intervention; cognitive behavior modification; cognitive behavior therapy; cognitive behavioral intervention; cognitive behavioral modification; cognitive behavioral therapy; cognitive behavioral treatment; Communication; Costs and Benefits; Dental Care; Dental Procedure; dental service; Dental Offices; Dental Staff; dental personnel; Dentistry; Dentists; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Environment; Fright; Fear; Focus Groups; Future; Dental General Practice; dental practice; Health; Learning; Longevity; Length of Life; life span; lifespan; Medicine; NIH; National Institutes of Health; United States National Institutes of Health; dental health; Oral health; Painful; Pain; Patients; well-being; wellbeing; Personal Satisfaction; Private Practice; Public Health; QOL; Quality of life; Racial Group; Racial Stocks; Race; Records; Research; Self-Administered; Self Administration; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Signal Transduction; Societies; Specialty; medical specialties; Tablets; Testing; Anti-Anxiety Agents; Anti-Anxiety Drugs; Anxiolytic Agents; Anxiolytics; Minor Tranquilizing Agents; antianxiety agent; antianxiety drugs; United States Dept. of Health and Human Services; Department of Health and Human Services; United States Department of Health and Human Services; Universities; Gender; Dental Anxiety; Dental Fear; Dental Phobia; Odontophobia; Businesses; Healthcare; health care; Mediating; Ecosystem; Ecologic Systems; Ecological Systems; base; Procedures; Phase; psychologic; psychological; Training; Dental; Individual; Development Plans; Ethnicity; Ethnic Origin; uptake; randomized control trial; Randomized Controlled Trials; tool; sedation; Sedation procedure; Adopted; Severities; Event; Oral; Clinic; System; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Operative Surgical Procedures; Visit; preference; Surgeon; American; experience; expectation; Reporting; social; Modeling; psychoeducation; response; Intervention Strategies; interventional strategy; Intervention; Effectiveness; Preventive; Data; NIDCR; NIDR; National Institute of Dental Research; National Institute of Dental and Craniofacial Research; Small Business Technology Transfer Research; STTR; follow-up; Active Follow-up; active followup; follow up; followed up; followup; Behavioral; active control; Evidence based treatment; cost; virtual; design; designing; Outcome; innovation; innovate; innovative; Evidence based intervention; demographics; standard care; standard treatment; intervention effect; clinical practice; operation; eHealth; e-Health; anxiety management; treatment group; negative affect; negative affectivity; treatment services; virtual reality exposure; Immersion