An interventional study of Cognitive Behavioral Therapy and Pain Education in Burn, Chronic Pain and Pain Catastrophizing, sponsored by Spaulding Rehabilitation Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Treatment
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.
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.
This 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:
Assessments and Imaging:
Assessments take place at baseline, 6 weeks (post-intervention), and 24 weeks (follow-up).
Study Aims
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 92 is above the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →Spaulding Rehabilitation Hospital is the lead sponsor of 117 studies on the registry; 27 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 17 (85%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Cognitive Behavioral Therapy
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.
Behavioral: Pain Education
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).
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.
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.
Time frame: Baseline and 6 weeks (post-intervention).
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).
Time frame: Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up).
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).
Time frame: Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up)
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.
Time frame: Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up).
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.
Time frame: Baseline, and 6 weeks (post-intervention).
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.
Time frame: Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up)
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.
Time frame: Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up)
Working Alliance Inventory (WAI)
Evaluates the strength, collaborative quality, and therapeutic bond formed between the participant and the interventionist.
Time frame: 6 weeks (post-intervention).
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data may be shared with external research collaborators upon request, subject to an IRB-approved Data Use Agreement (DUA).
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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