grant

Postoperative Telehealth Mindfulness Intervention to Improve Pain-related Outcomes and Reduce Opioid Use after Lumbar Spine Surgery

Organization VANDERBILT UNIVERSITY MEDICAL CENTERLocation NASHVILLE, UNITED STATESPosted 15 Aug 2021Deadline 31 Jul 2026
NIHUS FederalResearch GrantFY202521+ years old3-D3-Dimensional3DAcademic Medical CentersAddressAdultAdult HumanAffectAgeAnalgesia TestsAnxietyAreaAwardBehavior Conditioning TherapyBehavior ModificationBehavior TherapyBehavior TreatmentBehavioral Conditioning TherapyBehavioral ModificationBehavioral TherapyBehavioral TreatmentBeliefCNS plasticityChronic disabilityClinical InvestigatorClinical ResearchClinical StudyClinical TrialsClinical Trials DesignComplexConditioning TherapyDataData AnalysesData AnalysisData CollectionDevelopmentEducationEducational aspectsEnrollmentFeedbackFutureGeneralized GrowthGoalsGrantGrowthHomeHourIndividualInformation DisseminationInfrastructureInterventionIntervention TrialInterventional trialInterviewK23 AwardK23 MechanismK23 ProgramKnowledgeLong-term painMeasuresMental DepressionMentored Patient-Oriented Research Career Development AwardMentored Patient-Oriented Research Career Development Award (K23)MentorsMentorshipMethodologyMethodsMind-Body InterventionMind-Body MedicineNCCAMNCCIHNational Center for Complementary and Integrative HealthNational Center for Complementary and Integrative MedicineNeuronal PlasticityNociception TestsNon-pharmacologic TherapyNonpharmacologic InterventionNonpharmacologic TherapyNonpharmacologic approachNonpharmacologic treatmentOperative ProceduresOperative Surgical ProceduresOpiatesOpioidOrthopedicOrthopedic SurgeryOrthopedic Surgical ProfessionOrthopedicsOutcomePainPain AssessmentPain ControlPain MeasurementPain TherapyPain intensityPain interferencePain managementPain measurePainfulParticipantPatient Outcomes AssessmentsPatient Reported MeasuresPatient Reported OutcomesPatientsPersistent disabilityPersistent painPersonsPhysical FunctionPopulationPost-operative PainPostoperativePostoperative PainPostoperative PeriodPractice ManagementPrediction of Response to TherapyProceduresProspective StudiesProtocolProtocols documentationPsychophysicsPsychosocial FactorPublic HealthQOLQOL improvementQuality of lifeR-Series Research ProjectsR01 MechanismR01 ProgramRandomizedRandomized, Controlled TrialsRecommendationRecoveryReportingResearchResearch GrantsResearch Project GrantsResearch ProjectsResearch ResourcesResearch TrainingResourcesRisk FactorsScienceSelf EfficacySpinal ColumnSpinal painSpinal surgerySpineSpine painSpine surgeryStructureSurgicalSurgical InterventionsSurgical ProcedureSurvey InstrumentSurveysSystemTestingTimeTissue GrowthTrainingTreatment outcomeUnited StatesUniversity Medical CentersVertebral columnWorkWritingacceptability and feasibilityadulthoodagesarmbackbonebehavior interventionbehavioral interventionbiopsychosocialcareercareer developmentcentral nervous system plasticitycentral sensitizationchronic painclinical relevanceclinically relevantconstant paindata interpretationdelivered on-linedelivered onlinedepressiondesigndesigningdevelopmentaldisabilitydissemination of resultsemotional distressenrollexperiencefeeling distressfeeling upsetfunctional improvementgroup interventionhigh riskhomesimprove functionimprovedimproved functional outcomesimprovements in QOLimprovements in quality of lifeintervention participantsintervention refinementlasting painlearning activitylearning methodlearning strategieslearning strategylicit opioidmeetingmeetingsmind body approachmind body medicine skillsmind body techniquesmind body therapymind body treatmentsmind body wellnessmindfulnessmindfulness interventionmindfulness-based interventionmultidisciplinarynegative affectnegative affectivityneural plasticityneuroplasticneuroplasticitynon-drug therapynon-drug treatmentnondrug therapynondrug treatmenton-going painon-line deliveryongoing painonline deliveryontogenyopiate consumptionopiate crisisopiate drug useopiate intakeopiate medicationopiate useopioid consumptionopioid crisisopioid drug useopioid epidemicopioid intakeopioid medicationopioid usepain after surgerypain assaypain interventionpain outcomepain processingpain sensitivitypain treatmentpain-related outcomepatient centeredpatient orientedpatient populationpatient subclasspatient subclusterpatient subgroupspatient subpopulationspatient subsetspatient subtypespost interventionpost-surgical painpostsurgical painpredict therapeutic responsepredict therapy responseprescribed opiateprescribed opioidprescription opiateprescription opioidprogramspsychological distresspsychophysicalpsychosocialpsychosocial variablesquality of life improvementrandomisationrandomizationrandomized control trialrandomized, clinical trialsrandomly assignedresearch data disseminationresearch disseminationsatisfactionskillssurgerytelehealththerapy predictionthree dimensionaltreatment predictiontreatment response predictionvideoconferencevideoconferencesweb based delivery
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Full Description

Modified Project Summary/Abstract Section
This K23 award will support the candidate’s growth toward an independent clinical research career focused on developing and testing psychosocially-oriented mind-body interventions to improve the quality-of-life and treatment outcomes of chronic pain and postsurgical pain populations. Lumbar spine pain affects over 50 million individuals in the United States (US). The rate of spine surgeries performed in the US is the highest in the world. Yet, up to 40% of patients experience poor pain-related, functional, or quality of life outcomes after surgery. Despite the limited efficacy and high risks associated with long term opioid use, up to 50% of patients are prescribed opioids for up to 12 months following lumbar spine surgery. Nonpharmacological approaches addressing psychosocial risk factors for poor post-surgical outcomes are understudied and underutilized during postsurgical recovery. The proposed project aims to 1) adapt and refine a mindfulness-based intervention (MBI) for one-on-one telehealth delivery (live videoconference) to patients recovering from lumbar spine surgery by conducting a preliminary test of the MBI and collecting patient feedback using mixed methods; 2) conduct a two-arm pilot randomized controlled trial (RCT) of the postsurgical telehealth MBI vs. an education control to evaluate the feasibility and acceptability of the interventions and research procedures; and 3) summarize trajectories of pain-related outcomes (pain interference, opioid usage) and treatment targets (pain-related beliefs, mindfulness, psychophysical measures), within intervention groups and within key patient subgroups (levels of preoperative negative affect and opioid use status). The proposal targets career development in several areas: 1) developing and testing mind-body interventions utilizing mixed methods and longitudinal data collection and analysis; 2) randomized clinical trial design and methodology; 3) psychophysical testing of pain modulatory systems; 4) content knowledge in postoperative orthopaedic pain and opioid use; and 5) grant-writing skills. The candidate’s training goals will be achieved with the support of a multidisciplinary team of accomplished mentors and contributors, through targeted course work and seminars, culminating in completion of the proposed research project and dissemination of results. Training will take place in a resource-rich academic medical center with a top-performing surgical center and existing infrastructure for the prospective study of patients undergoing lumbar spine surgery. The findings will help tailor a telehealth MBI for an orthopaedic postsurgical population and provide preliminary data to optimize a well-powered RCT. This K23 award will promote the early career candidate in establishing an independent research program focused on optimizing telehealth mindfulness interventions in postsurgical and pain populations to inform the science and delivery of personalized pain management practices. The goals of this project are strongly aligned with NCCIH scientific priorities to address the widespread burden of chronic pain and the ongoing opioid epidemic.

Grant Number: 5K23AT011569-05
NIH Institute/Center: NIH

Principal Investigator: Carrie Brintz

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