2Morrow, Inc. SBIR Fast-Track Application - : 2Morrow, a small business established in 2011, is proposing a digital therapeutic for chronic pain that will utilize Acceptance and Commitment Therapy (ACT) techniques to improve coping skills and to address some of the common behavioral comorbidities that increase suffering in patients living with chronic pain. Proposed Product: Over 50M Americans are living with chronic pain. Patients living with pain have higher rates of depression, anxiety and substance use disorder, yet these behavioral risks are seldom addressed due to training, access, stigma or cost. We have learned from previous research that ACT can be used to improve coping skills, reduce anxiety and depression, and treat substance use disorder. To address this gap in care, 2Morrow will develop a new digital therapeutic product, 2MRx-CP, for use by patients with chronic pain. The program will combine established ACT protocols for chronic pain management with self screening tools for substance use disorders, anxiety and depression. It will also include behavioral science content, and daily tracking of patient metrics that will help to customize the intervention and provide data driven insights that can be used for shared decision making between the patient and provider. Our four Phase I specific aims are: 1) Conduct a quantitative evaluation of the existing 2Morrow Chronic Pain Self-Management Digital Health Program to address dissemination and implementation variables of appropriateness, acceptability, and feasibility; 2) Conduct a qualitative study of primary care provider (PCP) core teams to: a) determine best fit PCP clinic types for 2MRx-CP for the Phase II clinical study and our marketing strategy; and b) initiate development of the provider dashboard; 3) To initiate development of our new prescription-based digital program, 2MRx-CP, by reviewing data collected in Aims I-1 and 2, then developing a paper protocol of program core elements; and 4) 2Morrow will contract consultants to complete an audit of our current quality management processes and procedures to inform the formalized Phase II quality management system implementation. Our two Phase II specific aims are: 1) Conceptually design 2MRx-CP by incorporating data from Phase I and input from subject matter experts to create content, screening tools, algorithms and user experience. 2Morrow will then build a digital therapeutic for IOS and Android (patient apps); 2) Conduct a 2-arm randomized control feasibility study (N = 100 patients) to assess: 1) feasibility, appropriateness, and acceptability of 2MRx-CP digital therapeutic as an intervention for primary care patients with chronic pain; 2) feasibility of recruitment processes, study uptake, and completion of study outcome measures; and 3) estimate of the likely treatment efficacy effect size for a large RCT.
Public Health Relevance Statement: 2Morrow, Inc. SBIR Fast-Track Application -
Project narrative: 2Morrow is a small business, established in 2011, that provides smartphone applications for behavioral change. 2Morrow is proposing a digital chronic pain program that will utilize Acceptance and Commitment Therapy (ACT) techniques to improve coping skills and to address some of the common behavioral comorbidities that increase suffering in patients living with chronic pain. The digital therapeutic will engage the patient and include content and exercises, daily patient reported metrics, self screenings, information on risky medication use, and suggestions for approaching effective shared decision making with their provider based on data and insights from the program.
Project Terms: Algorithms; Pain Control; Pain Therapy; pain treatment; Pain management; Anxiety; Anxiety Disorders; Behavioral Sciences; Clinical Study; Clinical Research; Clinical Trials; depression; Mental Depression; Disease; Disorder; Eating Disorders; Elements; Feasibility Studies; Feedback; Foundations; Patient Care; Patient Care Delivery; Goals; Industry; Interview; Marketing; Mental Health; Mental Hygiene; Psychological Health; Methodology; Nicotine Dependence; nicotine addiction; nicotine dependent; Paper; Patient Outcomes Assessments; Patient Reported Measures; Patient Reported Outcomes; Patients; Quantitative Evaluations; Recommendation; Risk; Sensitivity Training Groups; T-Groups; Social Distance; statistics; Substance Use Disorder; Surveys; Survey Instrument; Technology; Testing; Thinking; thoughts; Time; Wellness Program; Businesses; Healthcare; health care; chronic pain; Custom; Social Impacts; base; Procedures; Clinical; Phase; screening tools; Screening procedure; Training; non-narcotic analgesic; non-opiate analgesic; non-opioid; non-opioid therapeutics; nonnarcotic analgesics; nonopiate analgesic; nonopioid; nonopioid analgesics; non-opioid analgesic; Funding; behavioral problem; Problem behavior; Contracting Opportunities; Contracts; tool; programs; Dependence; Clinic; Protocol; Protocols documentation; System; Country; experience; 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; Reporting; behavioral health; Intervention; Intervention Strategies; interventional strategy; Cell Phone; Cellular Telephone; iPhone; smart phone; smartphone; Cellular Phone; Provider; Therapeutic Uses; Address; Data; Economic Burden; Collection; Patient outcome; Patient-Centered Outcomes; Patient-Focused Outcomes; SBIR; Small Business Innovation Research; Small Business Innovation Research Grant; Monitor; Process; developmental; Development; feelings; Feeling; Behavioral; pandemic; pandemic disease; cost; digital; design; designing; Outcome; coping; usability; addiction; addictive disorder; commercialization; evidence base; product development; data sharing; Secure; Pain interference; mobile application; mobile app; mobile device application; power analysis; mobile platform; mobile technology; mobile computing; access to health care; access to healthcare; accessibility of health care; accessibility to health care; accessibility to healthcare; health care access; health care service access; health care service availability; healthcare access; healthcare accessibility; healthcare availability; healthcare service access; healthcare service availability; health care availability; Android; dashboard; opiate crisis; opioid crisis; opioid epidemic; primary care provider; care providers; self-management program; pain self-management; health care management; healthcare management; health management; patient with chronic pain; chronic pain patient; health goals; algorithm development; chronic pain control; chronic pain intervention; chronic pain therapy; chronic pain treatment; treat chronic pain; chronic pain management; Dissemination and Implementation; implementation process; acceptability and feasibility; implementation outcomes; digital therapeutics; digital therapy; digital treatment; digital health; remote patient monitoring; patient enrollment; participant enrollment
