This application responds to PA 20-262 for Small Business Innovation Research, Phase I, addressing SBA-approved NIDA-specified Area 2, Topic D: "Digital health therapeutics (e.g., Software as Medical Device,Software in Medical Device) focused on behavioral health interventions to alleviate the burden of SUD." The applicants (Affect Technologies, Inc.), propose to examine and confirm the technical merit and real-worldfeasibility of the Affect app as the core component of the Affect digital care program for treatment ofmethamphetamine use disorder (MUD). The project includes a clinical trial that will assemble data on thefunctionality of the app in engaging patients and delivering treatment components and services, usingoutputs to guide rapid refinements of the app's functions (e.g., active and passive data collection, patientinference engine, triggers for clinician actions, and user interfaces). The project will analyze these and otheraspects of the app to characterize their relationships with patient engagement, participation, and retention.Quantitative data on app feasibility/usability will include app usage statistics, and data on program impactson outcomes will consist of results of saliva drug tests of individuals with MUD as participants in the Phase Iresearch (N=90). Qualitative data on the clinical utility (acceptability and satisfaction) of the Affect app andprogram will be collected via all-virtual focus groups and app-enabled rating scales and questionnaireseliciting feedback from participants, clinicians, and stakeholders. Results will determine technicalmerit/feasibility and will inform refinements to the app and program correlated with outcomes, includingmethamphetamine use. Specific aims are to: Aim 1. Confirm the technical merit and feasibility of the Affectapp and its delivery of the Affect digital care program in real-world practice based on results from the clinicaltrial; Aim 2. Identify components of the Affect app and the Affect digital care program that correlate withpatient engagement, participation, retention, and changes in methamphetamine use; and Aim 3. Use resultsto iteratively refine the Affect app and care program to improve treatment of MUD toward substantiatingcommercialization. Demonstrating the clinical utility of the Affect digital care platform leading to betterpatient outcomes could improve clinical care for the 1.6 million people in the nation who need treatment forMUD, and it would increase access to serve the million users who never receive treatment. If shown to befeasible and effective in retaining participants in treatment, the Affect app will be an important element inefficiently achieving optimum patient outcomes at reasonable cost.
Public Health Relevance Statement: Project Narrative Demonstrating the technical merit/feasibility of the Affect app in delivering digital care for methamphetamine use disorder (MUD) would potentially improve clinical care for the 1.6 million people in the nation who need treatment for MUD. If shown to be clinically useful, well-received by patients, and effective in retaining participants in the care program, the Affect app will be an important element in efficiently achieving optimum patient outcomes at reasonable cost. Resulting knowledge will be useful to clinicians, technology developers, and researchers when disseminated in publications, offering new insights into innovative means to help individuals with MUD reduce methamphetamine use and succeed in recovery.
Project Terms: Affect ; Behavior ; Clinical Trials ; 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 ; Counseling ; Data Collection ; Disease ; Disorder ; Dropout ; Pharmacotherapy ; Drug Therapy ; drug treatment ; Elements ; Feedback ; Focus Groups ; Incentives ; Health Insurance ; health insurance plan ; knowledge of results ; Leadership ; Medicaid ; Medical Device ; United States National Institutes of Health ; NIH ; National Institutes of Health ; Patient Monitoring ; Patients ; Publications ; Scientific Publication ; Questionnaires ; Relapse ; Research ; Research Personnel ; Investigators ; Researchers ; Resources ; Research Resources ; Rewards ; Saliva ; Self Administration ; Self-Administered ; Computer software ; Software ; statistics ; Technology ; Testing ; Treatment Protocols ; Treatment Regimen ; Treatment Schedule ; Work ; Businesses ; Caring ; base ; improved ; Area ; Clinical ; Specific qualifier value ; Specified ; Phase ; insight ; Individual ; Recovery ; Logistics ; satisfaction ; Letters ; Therapeutic ; programs ; Event ; Services ; HIPAA ; Kennedy Kassebaum Act ; PL 104-191 ; PL104-191 ; Public Law 104-191 ; United States Health Insurance Portability and Accountability Act ; Health Insurance Portability and Accountability Act ; Participant ; treatment program ; Program Announcement ; NIH Program Announcements ; contingency management ; Manpower ; personnel ; Human Resources ; theories ; Cell Phone ; Cellular Telephone ; iPhone ; smart phone ; smartphone ; Cellular Phone ; Address ; Data ; M.D. ; Doctor of Medicine ; Ph.D. ; PhD ; Doctor of Philosophy ; NIDA ; National Institute on Drug Abuse ; National Institute of Drug Abuse ; Regulatory Pathway ; Patient-Focused Outcomes ; Patient outcome ; Patient-Centered Outcomes ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Small Business Technology Transfer Research ; STTR ; Principal Investigator ; Chairperson ; Chairman ; Chairwoman ; Output ; cost ; virtual ; digital ; design ; designing ; Outcome ; innovation ; innovate ; innovative ; skill acquisition ; skill development ; Evidence based intervention ; drug testing ; drug detection ; usability ; addiction ; addictive disorder ; commercialization ; multimodality ; multi-modality ; clinical care ; effective therapy ; effective treatment ; Secure ; Institutional Review Boards ; IRB ; IRBs ; behavioral health intervention ; behavioral economics ; methamphetamine use ; METH use ; METH using ; methamphetamine using ; peer support ; patient engagement ; participant engagement ; digital treatment ; digital therapeutics ; digital therapy ; digital healthcare ; digital care ; digital health care ; digital health ;
