Project Grant R21DE033502

Award Date 8/1/24
Completion Date 7/31/26
Dollars Obligated $459K
Federal Grant Program
93.121
Assistance Type
Project Grant
Place of Performance
Boston, MA 02114, USA
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DEVELOPMENT OF "FACE-FORWARD-WEB": A NOVEL WEB-BASED PROGRAM TARGETING PAIN-RELATED OUTCOMES AMONG PATIENTS WITH HETEROGENEOUS CHRONIC OROFACIAL PAIN - PROJECT SUMMARY BACKGROUND: CHRONIC OROFACIAL PAIN (COP) CONDITIONS ARE COMMON, COSTLY, AND DEBILITATING. THESE CONDITIONS ARE UNIFIED BY HIGH LEVELS OF PAIN-RELATED ACTIVITY LIMITATIONS, MALADAPTIVE COPING AND EMOTIONAL DISTRESS, WHICH ARE MOST OFTEN UNADDRESSED AND WORSEN EACH OTHER OVER TIME. THE MAJORITY OF COP TREATMENTS ARE BIOMEDICAL, OFTEN INEFFECTIVE, INVOLVE ADVERSE SIDE-EFFECTS, MISDIAGNOSES, AND CAN ENTAIL UNNECESSARY AND PAINFUL PROCEDURES THAT MAY LEAD TO IRREVERSIBLE DAMAGE. AVAILABLE PSYCHOSOCIAL INTERVENTIONS ARE LIMITED IN EFFECTIVENESS, ACCESSIBILITY, SCALABILITY, SCOPE, AVAILABILITY OF TRAINED PROVIDERS, AND INSURANCE COVERAGE. THEY ALSO RELY ON TALKING, POSING A SIGNIFICANT BARRIER TO PARTICIPATION FOR MANY PATIENTS WITH COP. "TALK-FREE" PSYCHOSOCIAL WEB-BASED PLATFORMS ARE NEEDED TO BYPASS THESE LIMITATIONS AND MAKE PSYCHOSOCIAL TREATMENT ACCESSIBLE, SCALABLE, AND GENERALIZABLE BUT DO NOT EXIST FOR ADULTS WITH HETEROGENOUS COP. THE GOAL OF THIS R21 PROPOSAL IS TO ADAPT THE RELAXATION RESPONSE RESILIENCY PROGRAM (3RP), AN EVIDENCE-BASED PROGRAM, FOR THE UNIQUE NEEDS OF PEOPLE WITH COP AND FOR ASYNCHRONOUS DELIVERY THROUGH A WEB-BASED PLATFORM. WE HAVE SHOWN THAT THE 3RP IMPROVES PAIN-RELATED ACTIVITY LIMITATIONS AND EMOTIONAL DISTRESS AMONG PEOPLE WITH REFRACTORY TEMPOROMANDIBULAR JOINT DISORDER (TMD) WHEN DELIVERED IN PERSON. HOWEVER, TO ASSURE ACCESSIBILITY, GENERALIZABILITY, SCALABILITY, AND FUTURE EFFICACY, IT IS ESSENTIAL TO ADAPT THE 3RP TO A "TALK-FREE" WEB PLATFORM TAILORED TO UNIQUE UNMET CHALLENGES IN COP. OUR GUIDING HYPOTHESIS (TO BE TESTED IN FUTURE WORK) IS THAT FACE-FORWARD-WEB WILL BE AN EFFECTIVE, EFFICIENT AND SCALABLE STRATEGY TO IMPROVE PAIN-RELATED ACTIVITY LIMITATIONS AND EMOTIONAL DISTRESS AMONG PATIENTS WITH COP. SPECIFIC AIMS AND RESEARCH DESIGN. WE WILL CONDUCT LIVE VIDEO FOCUS GROUPS (N=4-5 GROUPS/ N=20 INDIVIDUALS) WITH PEOPLE WHO HAVE HETEROGENEOUS COP TO UNDERSTAND TREATMENTS NEEDS AND PREFERENCES AND ADAPT THE INTERVENTION FOR ASYNCHRONOUS DELIVERY VIA A WEB-BASED PLATFORM - FACE-FORWARD-WEB, THE FIRST OF ITS KIND FOR THIS POPULATION (AIM 1); AND (2) ITERATIVELY OPTIMIZE FACE-FORWARD-WEB THROUGH A SERIES OF OPEN PILOTS WITH EXIT INTERVIEWS (2 WITH N=5 AND 1 WITH N=10) UNTIL CRITICAL GO/NO-GO FEASIBILITY AND ACCEPTABILITY BENCHMARKS ARE MET (AIM 2). THIS PROJECT ALIGNS WITH NIDCR'S STATED PRIORITIES OF SUPPORTING RESEARCH PROMOTING CRANIOFACIAL HEALTH, ALLEVIATING DISCOMFORT, AND EMBRACING TECHNOLOGY AS A DRIVER OF DISCOVERY. IMPACT: OUR INTERDISCIPLINARY TEAM OF PSYCHOLOGISTS, A DENTIST AND A NEUROLOGIST HAS PARTNERED WITH THE NATIONAL FACIAL PAIN ASSOCIATION TO COLLECT PRELIMINARY DATA AND FACILITATE RECRUITMENT FOR THIS PROJECT. WE HAVE EXTENSIVE EXPERTISE WITH MIXED METHODS, DEVELOPMENT OF WEB PLATFORMS, AND REMOTE CLINICAL TRIALS. RESULTS OF THIS STUDY WILL DIRECTLY INFORM A SUBSEQUENT UG3/UH3 NIDCR APPLICATION. IN THE UG3 WE WILL CONDUCT A SMALL PILOT RCT (NIH 1B) TO ENSURE OUR ABILITY TO RANDOMIZE AND FINALIZE OUR STUDY PROTOCOL, INCLUDING FIDELITY MEASUREMENT. IN THE UH3 PHASE WE WILL TEST THE EFFICACY OF FACE-FORWARD- WEB IN IMPROVING PAIN, ACTIVITY LIMITATIONS AND EMOTIONAL DISTRESS, AND TEST THEORY-DRIVEN MECHANISMS OF IMPROVEMENT THROUGH ADAPTIVE COPING. FACE-FORWARD-WEB, ADAPTED SPECIFICALLY FOR THE NEEDS OF THIS POPULATION AND DELIVERED THROUGH THEIR PREFERRED MODALITY, HAS THE POTENTIAL TO IMPROVE PAIN, ACTIVITY LIMITATIONS, AND EMOTIONAL DISTRESS IN THIS POPULATION.

Posted 7/29/24, 12:00 AM