Obsessive-compulsive disorder (OCD) is characterized by intrusive, distressing thoughts (obsessions) in response to which an individual feels compelled to perform a repetitive behavior (compulsions), which are performed in order to reduce the acute distress experienced by the patient but which perpetuate OCD symptoms. Effective treatment requires accurate reporting of compulsive behaviors, and a key challenge is that patients often underreport their behaviors to their providers because the short-term anxiety relief brought about by engaging in the compulsion is preferable to the long-term challenge of resisting the compulsions in order to treat the condition, thereby impairing the efficacy of these treatments. Available objective monitoring tools, such as electrocardiogram (ECG) monitors, can detect periods of increased anxiety, while wrist-worn devices can monitor behaviors such as hair pulling, but they have limited accuracy for detecting hand-washing compulsions which are common in OCD and are thus not indicated for use in these patients. The overall goals of this Phase 1 STTR are to address this key gap by developing and testing the feasibility of a technological innovation involving a novel wearable smart-ring recording modality that is unintrusive and provides a more objective measure of compulsive behavior to both patients and their therapists in order to appreciably improve the effectiveness of OCD treatment. This ring device offers several innovations: It is a smart ring (1) that can detect cleaning agents like water or alcohol (2) as well as repetitive behaviors (3) in order to objectively monitor obsessive hand-washing or other ritualistic events (4). This information would be sent to a dashboard (5) with a real-time log for a therapist to objectively measure the number of behaviors the ring detects and monitor wear- time compliance (6). Specific aims of this proposal are to: 1) Optimize acceptability, feasibility and utility of the ring device and its associated smartphone app/web interface through iterative 1:1 feedback from the range of users of this technology (patients/providers); 2) Develop a prototype activity recording smart ring and associated software system based on Aim 1 findings. The smart ring will be a miniature system that records movement, temperature, and wetness. It will record while worn and wirelessly download data, pairing with a smartphone app which will sync with a cloud storage modality; 3) Conduct a multi-phased acceptability, feasibility and experimental assessment protocol first with healthy adults and then with patients with OCD, followed by in-depth feedback interviews with clinicians. Advanced Medical Electronics has extensive experience in biomedical development, and academic partners (Asnaani, Gooneratne) have expertise in OCD, experimental methodology, mHealth, biomedical entrepreneurship, along with a prior track record of successful collaboration on previous STTR funded studies and proposals. If successful, this project will provide patients and health care providers with an unintrusive and more accurate tool for real-time monitoring of typical compulsive behaviors in order to appreciably improve the efficacy of front-line treatments for OCD.
Public Health Relevance Statement: Project Narrative The current application will develop a novel ring device designed to detect duration and frequency of engagement in behavioral compulsions (e.g., handwashing) with separate patient/healthcare data dashboards to assist patients with Obsessive Compulsive Disorder to more accurately monitor their compulsive behaviors to improve outcomes from behavior therapy. It includes repeated stakeholder feedback interviews, development of a device with key/most desirable features, and several experimental protocols to test for device acceptability, feasibility, and clinical utility by non-clinical and clinical samples.
Project Terms: Adult; 21+ years old; Adult Human; adulthood; Alcohols; Alcohol Chemical Class; Anxiety; Behavior; Behavior Therapy; Behavior Conditioning Therapy; Behavior Modification; Behavior Treatment; Behavioral Conditioning Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Conditioning Therapy; behavior intervention; behavioral intervention; Clinical Research; Clinical Study; Clinical Trials; Communities; Data Analyses; Data Analysis; data interpretation; Data Reporting; data representation; Disease; Disorder; Electrocardiogram; ECG; EKG; Electrocardiography; Medical Electronics; Fright; Fear; Feedback; Future; Patient Care; Patient Care Delivery; Goals; Grant; Hair; Handwashing; hand washing; Health Personnel; Health Care Providers; Healthcare Providers; Healthcare worker; health care personnel; health care worker; health provider; health workforce; healthcare personnel; medical personnel; treatment provider; Interview; Language; Lead; Pb element; heavy metal Pb; heavy metal lead; Medical Device; Mental Health; Mental Hygiene; Psychological Health; Methodology; Movement; body movement; NIH; National Institutes of Health; United States National Institutes of Health; Obsessive-Compulsive Neurosis; Obsessive-Compulsive Disorder; Patients; Pennsylvania; Psychologist; Publishing; Records; Research; Investigators; Researchers; Research Personnel; Software; Computer software; Technology; Temperature; Testing; Textbooks; thoughts; Thinking; Time; Universities; Utah; Water; Hydrogen Oxide; Wrist; Measures; Entrepreneurship; Entrepreneurial Skill; Device Designs; Healthcare; health care; Data Set; Dataset; Caring; base; improved; Area; Acute; Clinical; Phase; Distress; Rituals; Ritual compulsion; Obsession; Individual; Funding; Collaborations; tool; Frequencies; Event; Protocol; Protocols documentation; Pattern; System; Remission; Disease remission; Services; experience; Performance; skills; novel; Participant; Self-Report; Patient Self-Report; technological innovation; Prevention; Modality; Devices; Reporting; Position; Positioning Attribute; Sampling; response; Provider; Effectiveness; Address; Symptoms; Data; Detection; randomisation; randomization; randomly assigned; Randomized; Clinical Data; Observational Study; Observation research; Observation study; Observational research; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Small Business Technology Transfer Research; STTR; Monitor; Development; developmental; Behavioral; Behavior monitoring; behavioral monitoring; software systems; design; designing; Treatment Efficacy; intervention efficacy; therapeutic efficacy; therapy efficacy; cost effective; innovation; innovate; innovative; Impairment; clinically relevant; clinical relevance; user-friendly; web interface; prototype; commercialization; FDA approved; effective therapy; effective treatment; data portal; data sharing portal; mHealth; m-Health; mobile health; Big Data; BigData; compulsion; Compulsive Behavior; improved outcome; repetitive behavior; dashboard; cloud storage; cloud-based storage; smartphone Application; Android App; Android Application; Cell Phone Application; Cell phone App; Cellular Phone App; Cellular Phone Application; Smart Phone App; Smart Phone Application; Smartphone App; iOS app; iOS application; iPhone App; iPhone Application; treatment optimization; therapy optimization; real time monitoring; realtime monitoring; feasibility testing; Home; wireless
