SBIR-STTR Award

Evidence-Based Pain Intervention for Veterans: Leveraging Mobile & Social Media
Award last edited on: 5/15/2020

Sponsored Program
SBIR
Awarding Agency
NIH : NCCIH
Total Award Amount
$1,722,335
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Sara S Johnson

Company Information

Pro-Change Behavior Systems Inc

1174 Kingstown Road Unit 101
South Kingston, RI 02879
   (401) 360-2980
   info@prochange.com
   www.prochange.com
Location: Single
Congr. District: 02
County: Washington

Phase I

Contract Number: 1R43TR000362-01A1
Start Date: 8/1/2013    Completed: 3/31/2014
Phase I year
2013
Phase I Amount
$231,215
Chronic musculoskeletal pain creates a significant public health burden. Veterans are disproportionately affected by chronic musculoskeletal pain, and in particular, chronic low back pain (CLBP). The frequency and extent of co-occurrence of pain and PTSD, pain and Traumatic Brain Injury (TBI), and all three conditions (Post-deployment Multi-symptom Disorder (PMD)) can complicate and reduce the effectiveness of treatment for pain. The 2011 Institute of Medicine Blueprint for Relieving Pain in America calls for the promotion of self- management; reducing disparities among vulnerable subgroups (including Veterans); and the tailoring of pain care to each patient. Proponents of integrated treatment for PMD or the co-occurrence of pain with either TBI or PTSD are advocating for delivery of interventions that address multiple conditions. The proposed research represents an innovative response to those recommendations in that it will develop and examine the feasibility, acceptability, and preliminary effects of Sx3: Self Management of Pain, Sleep, & Stress Management a theoretically-grounded, mobile-optimized, Internet-based, interactive pain self-management program for chronic musculoskeletal pain. Unlike any existing pain intervention, Sx3: 1) is tailored specifically for Veterans' readiness to adopt self-management and preference for pain management strategies; 2) incorporates two of the core components of promising integrated treatments for PMD that are appropriate for Veterans with co-morbidities: sleep hygiene and stress management (relaxation training); and 3) leverages social networking, gaming principles, and SMS messaging to increase engagement and retention. Developed in collaboration with national pain self-management expert Dr. Robert Kerns, the computer- tailored intervention (CTI) will include a dynamic personal activity center, principles of gaming for health, social networking features, and optional text messages. Extensive end user and stakeholder input will ensure Sx3 is designed for rapid dissemination. Participants for formative focus groups (n=60); usability testing (n=20); and a pilot test (n=50) will be recruited from VA Connecticut Healthcare System. Formative focus group feedback will be combined with expert input to develop a prototype of an engaging self-management program tailored to readiness to adopt and preference for pain coping skills that incorporates sleep hygiene and stress management. Usability testing will allow the prototype to be refined before a 30-day pilot. Pilot participants will provide quantitative and qualitative acceptability data, and utilization data wil be examined. Pre-post comparisons of pain intensity; physical and emotional functioning; Patient Global Impression of Change; and readiness to adopt pain coping skills will provide preliminary data on the effects of the program. These data will inform program modifications needed to proceed with the Phase II effectiveness trial. Phase II will provide the impetus for commercialization of a cost-effective, evidence-based, population-based program that has the potential to improve pain self-management, functioning, and well-being.

Public Health Relevance Statement:


Public Health Relevance:
Chronic pain, and in particular, chronic musculoskeletal pain is all too common and imposes enormous costs on patients, society, and the health care system. The proposed research will develop and test a pain self- management program that 1) provides feedback uniquely matched to an individual's readiness to use helpful pain coping skills, improve sleep hygiene, and manage stress; 2) can be used on any computer or mobile device; 3) interfaces with social networking sites; 4) includes personalized text messages; and 5) uses principles of gaming for health to engage users. This computer tailored intervention offers a cost-effective, science-based, and easily deliverable solution to entire populations to increase self-management, reduce pain, and improve functioning and well-being.

Project Terms:
Address; Adopted; Advocate; Affect; Aftercare; American; Americas; base; behavior change; Behavioral; Cardiovascular Diseases; Caring; Chronic; Chronic low back pain; chronic pain; Cognitive; Collaborations; commercialization; Comorbidity; Computers; Connecticut; coping; Coping Skills; cost; cost effective; Data; design; Devices; Diabetes Mellitus; Disease; Economic Burden; effectiveness trial; Emotional; Ensure; Equilibrium; Evaluation; evidence base; Exercise; Feedback; Focus Groups; follow-up; Freedom; Frequencies (time pattern); Friends; General Population; Health; health administration; Healthcare Systems; Hygiene; impression; improved; improved functioning; indexing; Individual; innovation; Institute of Medicine (U.S.); Internet; Intervention; Language; Malignant Neoplasms; Mental Health; Modification; Musculoskeletal Diseases; Musculoskeletal Pain; Nature; Numeric Rating Scale; operation; Opioid; Outcome; Pain; Pain intensity; Pain management; Participant; Patient Education; Patients; Personal Satisfaction; Phase; Pilot Projects; Population; population based; Post-Traumatic Stress Disorders; preference; Prevalence; Program Development; programs; Protocols documentation; prototype; public health medicine (field); public health relevance; Readiness; Recommendation; Recruitment Activity; Relaxation; Relaxation Therapy; Reporting; Research; response; Risk; Role; satisfaction; Schedule; Science; Self Management; Sleep; social; Social Network; social networking website; Societies; Solutions; Staging; Stress; stress management; Subgroup; Symptoms; System; Techniques; Testing; Text; Traumatic Brain Injury; Treatment Effectiveness; usability; Veterans

Phase II

Contract Number: 9R44AT009675-02
Start Date: 8/1/2013    Completed: 2/29/2020
Phase II year
2017
(last award dollars: 2020)
Phase II Amount
$1,491,120

Chronic musculoskeletal pain creates a significant public health burden, and Veterans are disproportionately affected. The frequency and extent of co-occurrence of pain and PTSD, pain and Traumatic Brain Injury (TBI), all three conditions (Post-deployment Multi-symptom Disorder (PMD), and other multi-symptom syndromes can complicate and reduce the effectiveness of pain treatment. Furthermore, the majority of Veterans do not seek care in VA settings, requiring an approach that will be available to all Veterans. The Blueprint for Relieving Pain in America and National Pain Strategy call for the promotion of self-management; reducing disparities among vulnerable subgroups (e.g., Veterans); and the tailoring of pain care. Proponents of integrated treatment for common co-morbid conditions are advocating for interventions that address multiple conditions. This Phase II proposal builds on a successful NACTS-funded Phase I SBIR that developed and pilot tested a theoretically-grounded, mobile- optimized, interactive pain self-management intervention for Veterans with chronic musculoskeletal pain. Health eRide: Your Journey to Managing Pain 1) was tailored specifically to Veterans' readiness and preferred strategies for pain self-management; 2) leveraged SMS messaging, social networking, and gaming principles to increase engagement and retention; and 3) helped to address the co-occurrence of PTSD and TBI by including health behavior change messages for sleep hygiene and stress management. At 30-day follow-up, participants (n=44) reported significant reductions in pain and pain impact, as well as increased readiness to employ self-management strategies. Over 68% of participants reported favorable global impression of change. Phase II will involve 1) completing the development of Health eRide by transforming it into an app and enhancing its functionality for mobile browsers, enhancing the social networking and gaming features, and adding e-coaching capabilities; and 2) conducting a year- long randomized trial in which 540 Veterans with chronic pain recruited from both VA facilities and the community are randomly assigned to Health eRide or an online educational cognitive- behavioral therapy intervention. Differences in pain intensity and interference will be examined at 6 months (immediately post-intervention) and 12-months. A number of secondary analyses will be conducted to examine the impact Health eRide has on other outcomes (e.g., PTSD symptoms). A successful trial will set the stage for widespread dissemination of an efficacious, easily accessible tailored pain self-management intervention to address an urgent need among our nation's Veterans as well as an adaptation for general adult populations.

Public Health Relevance Statement:
Relevance: Chronic pain, and in particular, chronic musculoskeletal pain is all too common (especially among Veterans) and imposes enormous costs on patients, society, and the health care system. The proposed research will conduct a rigorous scientific study of the effects of a pain self-management program that 1) provides feedback uniquely matched to an individual Veteran's readiness to use helpful pain coping skills, improve sleep habits, and manage stress; 2) can be used as a mobile phone app or on any computer, tablet, or mobile device; 3) interfaces with social networking sites; 4) includes personalized text messages or push notifications; and 5) uses principles of gaming for health to engage users. This intervention offers a cost-effective, science-based, and easily deliverable solution to entire populations to increase self-management, reduce pain, and improve functioning and well-being.

Project Terms:
Address; Adopted; Adult; Advocate; Affect; American; Americas; base; behavior change; Car Phone; Caring; Chronic; chronic pain; Cognitive Therapy; common treatment; Communities; community setting; Computers; coping; Coping Skills; cost; cost effective; Data; Death Rate; Decision Making; Development; Diabetes Mellitus; Disease; disparity reduction; Economics; Educational Curriculum; Effectiveness; Elements; evidence base; experience; Feedback; follow-up; Freedom; Frequencies; Funding; Goals; Habits; handheld mobile device; Health; health administration; Health behavior change; Healthcare; healthcare community; Healthcare Systems; Heart Diseases; Hygiene; impression; improved; improved functioning; Individual; Individual Differences; innovation; Institutes; Internet; Intervention; Life; Malignant Neoplasms; Maps; Mental Health; Modeling; Motivation; Musculoskeletal Diseases; Musculoskeletal Pain; neglect; non-drug; Notification; Online Systems; operation; Opioid; Outcome; Overdose; Pain; Pain Clinics; Pain intensity; Pain interference; Pain management; Participant; patient oriented; Patients; Phase; Play; Population; post intervention; Post-Traumatic Stress Disorders; preference; Prevalence; Primary Health Care; Problem Solving; programs; prototype; Public Health; Randomized; randomized trial; Readiness; Recommendation; Recruitment Activity; Reporting; Research; Resources; Role; Science; secondary analysis; secondary outcome; Self Management; Severities; skills; Sleep; Sleep Disorders; Small Business Innovation Research Grant; social media; Social Network; social networking website; Societies; Soldier; Stress; stress management; Subgroup; Subway; Suggestion; Symptoms; Syndrome; Tablet Computer; Testing; Text; Therapeutic Intervention; Traumatic Brain Injury; Underserved Population; usability; Veterans; Vulnerable Populations