[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656468":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":51,"studyPopulation":43,"armGroups":52,"interventions":65,"overallOfficials":43,"centralContacts":73,"locations":43,"responsibleParty":79,"collaborators":43,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":43,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":43,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":107,"whyStopped":43,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":43},{"fullName":5,"class":6},"Spaulding Rehabilitation Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"fMRI Measure","Participants will undergo functional MRI scan sessions, including resting-state fMRI and task-based BOLD fMRI. Task-based fMRI utilizes a block-design contrasting 6 Pain Catastrophizing Scale statements (covering helplessness, magnification, and rumination) against 6 lexically matched neutral control statements.","Baseline and 6 weeks (post-intervention).",[14,18],{"measure":15,"description":16,"timeFrame":17},"Pain Catastrophizing Scale (PCS)","The Pain Catastrophizing Scale (PCS) will be used to evaluate negative cognitive-emotional responses to pain across three subscales: helplessness, magnification, and rumination. Scores range from 0 to 52, with higher scores indicating greater pain catastrophizing (worse outcome).","Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up).",{"measure":19,"description":20,"timeFrame":21},"Brief Pain Inventory (BPI)","Measured using the Brief Pain Inventory (BPI) Pain Interference subscale. Evaluates how pain impacts daily activities, mood, mobility, work, relationships, sleep, and enjoyment of life on a scale of 0 to 10, where higher scores indicate greater pain interference (worse outcome).","Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up)",[23,26,30,33,36],{"measure":24,"description":25,"timeFrame":17},"Patient-Reported Outcomes Measurement Information System (PROMIS-29)","Measured using the 29-item Patient Reported Outcomes Measurement Information System (PROMIS-29). Evaluates sub-scores for physical function, fatigue, sleep disturbance, social participation, depression, and anxiety.",{"measure":27,"description":28,"timeFrame":29},"Quantitative Sensory Testing (QST) Battery","An in-person somatosensory assessment utilizing calf cuff pressure algometry to evaluate individual pain thresholds (mild, moderate, and high pain) as well as dynamic pain mechanisms, including temporal summation of pain and conditioned pain modulation.","Baseline, and 6 weeks (post-intervention).",{"measure":31,"description":32,"timeFrame":21},"Coping Strategies Questionnaire","Assesses cognitive and behavioral strategies used to cope with pain, including distraction, coping self-statements, and other pain management approaches. Higher scores indicate greater use of the specified coping strategy.",{"measure":34,"description":35,"timeFrame":21},"Pain Self-Efficacy Scale","Assesses an individual's confidence in their ability to perform daily activities, achieve goals, and manage the consequences of chronic pain. Higher scores indicate greater pain self-efficacy.",{"measure":37,"description":38,"timeFrame":39},"Working Alliance Inventory (WAI)","Evaluates the strength, collaborative quality, and therapeutic bond formed between the participant and the interventionist.","6 weeks (post-intervention).",{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":43,"timePerspective":43,"maskingInfo":45},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":46,"maskingDescription":43,"whoMasked":47},"TRIPLE",[48,49,50],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Pain is particularly prevalent (\\>50%) and disabling following burn injuries. Chronic pain is strongly modulated by negative affect, and pain catastrophizing, a pain-specific psychosocial construct comprising helplessness, pessimism, rumination, and magnification about pain-related symptoms, is a critical predictor of pain severity and treatment satisfaction. Non-pharmacologic interventions such as Cognitive Behavioral Therapy (CBT) improve pain partially by reducing catastrophizing. However, the underlying neurobiology supporting catastrophizing in burn injury survivors remains understudied. Identifying objective, catastrophizing-linked neural biomarkers may serve as important therapeutic targets and predict clinical treatment response.\n\nThis study is a randomized, longitudinal neuroimaging trial evaluating the mechanisms of CBT compared to an active educational control. Participants with chronic burn pain are randomized in a 1:1 ratio to undergo one of two 6-week, remotely delivered interventions:\n\n* CBT: Features 6 weekly 60-minute virtual sessions using active, structured cognitive-behavioral techniques. The intervention focuses on acquiring and practicing cognitive and emotional modulatory skills (e.g., relaxation, thought-stopping, distraction, cognitive restructuring) to reduce maladaptive pain-related cognitions.\n* Pain Education (EDU): An active control condition matched for professional contact time, consisting of 6 weekly virtual sessions covering general pain-related topics (e.g., Gate-Control Theory, pain types) without active pain-coping skill acquisition or home practice.\n\nAssessments and Imaging:\n\nAssessments take place at baseline, 6 weeks (post-intervention), and 24 weeks (follow-up).\n\n* Neuroimaging: Participants undergo 3-Tesla brain MRI sessions at baseline and 6 weeks, including structural MRI, resting-state fMRI, and a pain catastrophizing fMRI task.\n* fMRI Task: Patients view and reflect on statements from the Pain Catastrophizing Scale (PCS) intermixed with matched neutral statements in a block design during functional scanning.\n* Sensory and Clinical Measures: Baseline visits include Quantitative Sensory Testing (QST) via cuff pressure algometry.\n* Validated questionnaires are administered at all timepoints to measure pain interference (Brief Pain Inventory), catastrophizing (PCS), coping, self-efficacy, and general psychosocial functioning (PROMIS-29).\n\nStudy Aims\n\n* Aim 1: Investigate the association between brain processing of catastrophizing and individual differences in pain intensity and interference among burn-injury survivors. H1.1: Patients with more burn-associated pain and worse interference will show greater catastrophizing-induced activation in posterior cingulate cortex (PCC). H1.2: Patients with more pain and interference will also show greater catastrophizing-induced connectivity between PCC and salience network regions, such as anterior mid-cingulate cortex (aMCC).\n* Aim 2: Evaluate whether CBT (compared to pain education (EDU)) results in greater improvement in pain and catastrophizing, and reduced brain response to catastrophizing cues. H2.1: Patients randomized to CBT, compared to EDU, will report greater reductions in pain interference and catastrophizing. H2.2: Patients randomized to CBT, compared to EDU, will show greater reduction in PCC responses to catastrophizing cues. H2.3: Greater reduction in catastrophizing will be correlated with greater reduction in PCC responses.\n* Aim 3: Determine whether baseline PCC response to catastrophizing cues (after controlling for patient-reported catastrophizing scores) predicts improvement in pain outcomes following CBT, and whether changes in PCC catastrophizing response mediate changes in pain outcomes. H3.1: Based on our preliminary data, greater aMCC activation and PCC-to-aMCC connectivity response to catastrophizing cues at baseline will predict greater reductions in pain interference and catastrophizing following CBT (but not EDU). H3.2: Change in catastrophizing cue PCC responses following therapy will mediate the improvements in pain interference following CBT (versus EDU).",[53,59],{"label":54,"type":55,"description":56,"interventionNames":57},"Cognitive Behavioral Therapy","EXPERIMENTAL","Participants receive an 6-week course of remotely delivered Cognitive Behavioral Therapy via secure video conferencing (1 weekly session, approximately 60 minutes each). The intervention focuses on a pain self-management paradigm, cognitive restructuring, and skill-building exercises (e.g., relaxation, thought-stopping, distraction) along with in-vivo and home practice to target and reduce maladaptive pain-related cognitions.",[58],"Behavioral: Cognitive Behavioral Therapy",{"label":60,"type":61,"description":62,"interventionNames":63},"Pain Education","ACTIVE_COMPARATOR","Participants receive an 6-week course of remotely delivered Pain Education via secure video conferencing (1 weekly session, approximately 60 minutes each). Sessions cover general pain-related topics (e.g., Gate-Control Theory, acute vs. chronic pain, working with health care providers) without incorporating active coping skills training, handouts, or at-home practice.",[64],"Behavioral: Pain Education",[66,70],{"type":67,"name":54,"description":68,"armGroupLabels":69,"otherNames":43},"BEHAVIORAL","An 6-week, remotely delivered behavioral intervention administered weekly via secure video conferencing by a trained psychologist (approximately 60 minutes per session). It utilizes active, structured techniques (such as relaxation, thought-stopping, distraction, and cognitive restructuring) along with in-vivo and home practice to target and reduce maladaptive pain-related cognitions (i.e., pain catastrophizing).",[54],{"type":67,"name":60,"description":71,"armGroupLabels":72,"otherNames":43},"An 6-week, remotely delivered educational control intervention administered weekly via secure video conferencing by a trained psychologist (approximately 60 minutes per session). Matched for therapist contact time with the Cognitive Behavioral Therapy group, sessions cover standard pain-related topics (e.g., Gate-Control Theory, types of chronic pain, working with healthcare providers) without active skill-building components, handouts, or at-home practice.",[60],[74],{"name":75,"role":76,"phone":77,"phoneExt":43,"email":78},"Jeffrey C. Schneider, MD","CONTACT","6179526329","JCSCHNEIDER@MGH.HARVARD.EDU",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","Jeffrey Schneider","Associate Professor, Harvard Medical School","100656468","neurobiology-of-pain-in-burn-survivors-100656468",false,"NCT07824635","Neurobiology of Pain in Burn Survivors","Neurobiology of Pain in Burn Survivors: Identification and Targeting of a Critical Treatment Mechanism","Inclusion Criteria:\n\n* Previously hospitalized for burn injury\n* Age 18 to 65 years\n* Able to provide written informed consent and fluent in English\n* Living in a community setting\n* Six (6) months or more post-burn injury\n* Burn-related pain rated as ≥4 (on a scale of 0-10) over the past week, co-localized with the site of the burn injury\n\nExclusion Criteria:\n\n* Comorbid acute pain condition.\n* Comorbid chronic pain condition that is rated by the participant as more painful than the burn injury pain.\n* Living in an institution or medical facility.\n* Pregnant or nursing.\n* Any psychiatric condition precluding study participation, such as a disorder involving psychosis (e.g., schizophrenia), unmanaged bipolar disorder, or a severe personality disorder.\n* History of anxiety disorders or significant anxiety symptoms interfering with imaging procedures (e.g., panic).\n* Contraindication to MRI (e.g., implanted ferrous metal).\n* History of significant head injury (e.g., with substantial loss of consciousness).\n* Psychiatric hospitalization in the past 6 months.\n* Currently participating in therapeutic clinical research trials.","ALL","18 Years","65 Years",{"count":94,"type":95},92,"ESTIMATED","INTERVENTIONAL",[98],"NA","Many burn survivors experience persistent, disabling pain that is strongly influenced by pain catastrophizing, a pattern of negative cognitive and emotional responses to pain involving feelings of helplessness, rumination, and magnification of symptoms. The primary purpose of this study is to evaluate whether an 6-week, remotely delivered cognitive-behavioral therapy program reduces pain interference (disruption to daily life) and pain catastrophizing more effectively than an 6-week pain education. Researchers also aim to identify the neurobiological mechanisms through which non-pharmacologic pain management works using functional Magnetic Resonance Imaging brain scans.",[101,102,103],"Burn","Chronic Pain","Pain Catastrophizing",[105,54,106],"Burn Injury","fMRI","NOT_YET_RECRUITING","2026-09-17",{"date":110,"type":111},"2026-09-22","ACTUAL",{"date":113,"type":95},"2027-01",{"date":115,"type":95},"2031-10",{"name":5,"class":6}]