BurnNCT07824635
Neurobiology of Pain in Burn Survivors
A study testing Cognitive Behavioral Therapy and Pain Education in people with Burn and Chronic Pain, run by Spaulding Rehabilitation Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burn, Chronic Pain, Pain Catastrophizing
- What is being tested?
- Cognitive Behavioral Therapy and Pain Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously hospitalized for burn injury
- Age 18 to 65 years
- Able to provide written informed consent and fluent in English
- Living in a community setting
- Six (6) months or more post-burn injury
- 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
Who cannot join
- Comorbid acute pain condition.
- Comorbid chronic pain condition that is rated by the participant as more painful than the burn injury pain.
- Living in an institution or medical facility.
- Pregnant or nursing.
- Any psychiatric condition precluding study participation, such as a disorder involving psychosis (e.g., schizophrenia), unmanaged bipolar disorder, or a severe personality disorder.
- History of anxiety disorders or significant anxiety symptoms interfering with imaging procedures (e.g., panic).
Show all 10Show fewer
- Contraindication to MRI (e.g., implanted ferrous metal).
- History of significant head injury (e.g., with substantial loss of consciousness).
- Psychiatric hospitalization in the past 6 months.
- Currently participating in therapeutic clinical research trials.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Neurobiology of Pain in Burn Survivors: Identification and Targeting of a Critical Treatment Mechanism
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.
Read the detailed description
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:
- 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.
- 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.
Assessments and Imaging:
Assessments take place at baseline, 6 weeks (post-intervention), and 24 weeks (follow-up).
- 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.
- 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.
- Sensory and Clinical Measures: Baseline visits include Quantitative Sensory Testing (QST) via cuff pressure algometry.
- 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).
Study Aims
- 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).
- 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.
- 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).
- Conditions
- Burn, Chronic Pain, Pain Catastrophizing
- Being tested
- Cognitive Behavioral Therapy, Pain Education
- Keywords
- Burn Injury, Cognitive Behavioral Therapy, fMRI
- Medical subject headings
- Burns, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
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).
Pain EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioral Therapy |
| 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. Receives: Behavioral: Pain Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks (post-intervention).
Secondary outcomes (2)
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).
Measured: 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).
Measured: Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Schneider, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824635
- Sponsor's protocol ID
- 2026P001589
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data may be shared with external research collaborators upon request, subject to an IRB-approved Data Use Agreement (DUA).
Publications
MacKinnon DP, Lockwood CM, Hoffman JM, West SG, Sheets V. A comparison of methods to test mediation and other intervening variable effects. Psychol Methods. 2002 Mar;7(1):83-104. doi: 10.1037/1082-989x.7.1.83.
PubMed 11928892McLaren DG, Ries ML, Xu G, Johnson SC. A generalized form of context-dependent psychophysiological interactions (gPPI): a comparison to standard approaches. Neuroimage. 2012 Jul 16;61(4):1277-86. doi: 10.1016/j.neuroimage.2012.03.068. Epub 2012 Mar 30.
PubMed 22484411Gorgolewski KJ, Auer T, Calhoun VD, Craddock RC, Das S, Duff EP, Flandin G, Ghosh SS, Glatard T, Halchenko YO, Handwerker DA, Hanke M, Keator D, Li X, Michael Z, Maumet C, Nichols BN, Nichols TE, Pellman J, Poline JB, Rokem A, Schaefer G, Sochat V, Triplett W, Turner JA, Varoquaux G, Poldrack RA. The brain imaging data structure, a format for organizing and describing outputs of neuroimaging experiments. Sci Data. 2016 Jun 21;3:160044. doi: 10.1038/sdata.2016.44.
PubMed 27326542Lazaridou A, Kim J, Cahalan CM, Loggia ML, Franceschelli O, Berna C, Schur P, Napadow V, Edwards RR. Effects of Cognitive-Behavioral Therapy (CBT) on Brain Connectivity Supporting Catastrophizing in Fibromyalgia. Clin J Pain. 2017 Mar;33(3):215-221. doi: 10.1097/AJP.0000000000000422.
PubMed 27518491Ben-David BM, van Lieshout PH, Leszcz T. A resource of validated affective and neutral sentences to assess identification of emotion in spoken language after a brain injury. Brain Inj. 2011;25(2):206-20. doi: 10.3109/02699052.2010.536197. Epub 2010 Nov 30.
PubMed 21117915Polianskis R, Graven-Nielsen T, Arendt-Nielsen L. Computer-controlled pneumatic pressure algometry--a new technique for quantitative sensory testing. Eur J Pain. 2001;5(3):267-77. doi: 10.1053/eujp.2001.0245.
PubMed 11558982Petersen KK, Kilic K, Hertel E, Sejersgaard-Jacobsen TH, Jorgensen MK, Troelsen A, Arendt-Nielsen L, Boye Larsen D. Quantitative sensory testing as an assessment tool to predict the response to standard pain treatment in knee osteoarthritis: a systematic review and meta-analysis. Pain Rep. 2023 Jun 5;8(4):e1079. doi: 10.1097/PR9.0000000000001079. eCollection 2023 Jul-Aug.
PubMed 38699564Georgopoulos V, Akin-Akinyosoye K, Zhang W, McWilliams DF, Hendrick P, Walsh DA. Quantitative sensory testing and predicting outcomes for musculoskeletal pain, disability, and negative affect: a systematic review and meta-analysis. Pain. 2019 Sep;160(9):1920-1932. doi: 10.1097/j.pain.0000000000001590.
PubMed 31045746Harden RN, Weinland SR, Remble TA, Houle TT, Colio S, Steedman S, Kee WG; American Pain Society Physicians. Medication Quantification Scale Version III: update in medication classes and revised detriment weights by survey of American Pain Society Physicians. J Pain. 2005 Jun;6(6):364-71. doi: 10.1016/j.jpain.2005.01.350.
PubMed 15943958Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
PubMed 11132119Andrusyna TP, Tang TZ, DeRubeis RJ, Luborsky L. The factor structure of the working alliance inventory in cognitive-behavioral therapy. J Psychother Pract Res. 2001 Summer;10(3):173-8.
PubMed 11402080Deyo RA, Katrina Ramsey, Buckley DI, Michaels L, Kobus A, Eckstrom E, Forro V, Morris C. Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain. Pain Med. 2016 Feb;17(2):314-24. doi: 10.1093/pm/pnv046.
PubMed 26814279Revicki DA, Chen WH, Harnam N, Cook KF, Amtmann D, Callahan LF, Jensen MP, Keefe FJ. Development and psychometric analysis of the PROMIS pain behavior item bank. Pain. 2009 Nov;146(1-2):158-69. doi: 10.1016/j.pain.2009.07.029. Epub 2009 Aug 15.
PubMed 19683873Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.
PubMed 22250775Anderson KO, Dowds BN, Pelletz RE, Edwards TW, Peeters-Asdourian C. Development and initial validation of a scale to measure self-efficacy beliefs in patients with chronic pain. Pain. 1995 Oct;63(1):77-83. doi: 10.1016/0304-3959(95)00021-J.
PubMed 8577493
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiology of Pain in Burn Survivors: Identification and Targeting of a Critical Treatment Mechanism
- ClinicalTrials.gov ID
- NCT07824635
- Acronym / sponsor ID
- 2026P001589
- Conditions
- Burn, Chronic Pain, Pain Catastrophizing
- Keywords
- Burn Injury, Cognitive Behavioral Therapy, fMRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
- 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.
Assessments and Imaging:
Assessments take place at baseline, 6 weeks (post-intervention), and 24 weeks (follow-up).
- 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.
- 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.
- Sensory and Clinical Measures: Baseline visits include Quantitative Sensory Testing (QST) via cuff pressure algometry.
- 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).
Study Aims
- 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).
- 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.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyParticipants 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. |
| Pain Education | Active comparator | Behavioral: Pain EducationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Previously hospitalized for burn injury
- Age 18 to 65 years
- Able to provide written informed consent and fluent in English
- Living in a community setting
- Six (6) months or more post-burn injury
Key exclusion criteria (10 listed)
- Comorbid acute pain condition.
- Comorbid chronic pain condition that is rated by the participant as more painful than the burn injury pain.
- Living in an institution or medical facility.
- Pregnant or nursing.
- Any psychiatric condition precluding study participation, such as a disorder involving psychosis (e.g., schizophrenia), unmanaged bipolar disorder, or a severe personality disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyAn 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). | Behavioural | Cognitive Behavioral Therapy |
| Pain EducationAn 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. | Behavioural | Pain Education |
Primary outcome
fMRI Measure
Time frame: Baseline and 6 weeks (post-intervention).
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.
2 secondary outcomes
Pain Catastrophizing Scale (PCS)
Time frame: Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up).
Brief Pain Inventory (BPI)
Time frame: Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 11928892MacKinnon DP, Lockwood CM, Hoffman JM, West SG, Sheets V. A comparison of methods to test mediation and other intervening variable effects. Psychol Methods. 2002 Mar;7(1):83-104. doi: 10.1037/1082-989x.7.1.83.
- Background: PubMed 22484411McLaren DG, Ries ML, Xu G, Johnson SC. A generalized form of context-dependent psychophysiological interactions (gPPI): a comparison to standard approaches. Neuroimage. 2012 Jul 16;61(4):1277-86. doi: 10.1016/j.neuroimage.2012.03.068. Epub 2012 Mar 30.
- Background: PubMed 27326542Gorgolewski KJ, Auer T, Calhoun VD, Craddock RC, Das S, Duff EP, Flandin G, Ghosh SS, Glatard T, Halchenko YO, Handwerker DA, Hanke M, Keator D, Li X, Michael Z, Maumet C, Nichols BN, Nichols TE, Pellman J, Poline JB, Rokem A, Schaefer G, Sochat V, Triplett W, Turner JA, Varoquaux G, Poldrack RA. The brain imaging data structure, a format for organizing and describing outputs of neuroimaging experiments. Sci Data. 2016 Jun 21;3:160044. doi: 10.1038/sdata.2016.44.
- Background: PubMed 27518491Lazaridou A, Kim J, Cahalan CM, Loggia ML, Franceschelli O, Berna C, Schur P, Napadow V, Edwards RR. Effects of Cognitive-Behavioral Therapy (CBT) on Brain Connectivity Supporting Catastrophizing in Fibromyalgia. Clin J Pain. 2017 Mar;33(3):215-221. doi: 10.1097/AJP.0000000000000422.
- Background: PubMed 21117915Ben-David BM, van Lieshout PH, Leszcz T. A resource of validated affective and neutral sentences to assess identification of emotion in spoken language after a brain injury. Brain Inj. 2011;25(2):206-20. doi: 10.3109/02699052.2010.536197. Epub 2010 Nov 30.
- Background: PubMed 11558982Polianskis R, Graven-Nielsen T, Arendt-Nielsen L. Computer-controlled pneumatic pressure algometry--a new technique for quantitative sensory testing. Eur J Pain. 2001;5(3):267-77. doi: 10.1053/eujp.2001.0245.
- Background: PubMed 38699564Petersen KK, Kilic K, Hertel E, Sejersgaard-Jacobsen TH, Jorgensen MK, Troelsen A, Arendt-Nielsen L, Boye Larsen D. Quantitative sensory testing as an assessment tool to predict the response to standard pain treatment in knee osteoarthritis: a systematic review and meta-analysis. Pain Rep. 2023 Jun 5;8(4):e1079. doi: 10.1097/PR9.0000000000001079. eCollection 2023 Jul-Aug.
- Background: PubMed 31045746Georgopoulos V, Akin-Akinyosoye K, Zhang W, McWilliams DF, Hendrick P, Walsh DA. Quantitative sensory testing and predicting outcomes for musculoskeletal pain, disability, and negative affect: a systematic review and meta-analysis. Pain. 2019 Sep;160(9):1920-1932. doi: 10.1097/j.pain.0000000000001590.
- Background: PubMed 15943958Harden RN, Weinland SR, Remble TA, Houle TT, Colio S, Steedman S, Kee WG; American Pain Society Physicians. Medication Quantification Scale Version III: update in medication classes and revised detriment weights by survey of American Pain Society Physicians. J Pain. 2005 Jun;6(6):364-71. doi: 10.1016/j.jpain.2005.01.350.
- Background: PubMed 11132119Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
- Background: PubMed 11402080Andrusyna TP, Tang TZ, DeRubeis RJ, Luborsky L. The factor structure of the working alliance inventory in cognitive-behavioral therapy. J Psychother Pract Res. 2001 Summer;10(3):173-8.
- Background: PubMed 26814279Deyo RA, Katrina Ramsey, Buckley DI, Michaels L, Kobus A, Eckstrom E, Forro V, Morris C. Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain. Pain Med. 2016 Feb;17(2):314-24. doi: 10.1093/pm/pnv046.
- Individual participant dataSharing planned: Yes. De-identified individual participant data may be shared with external research collaborators upon request, subject to an IRB-approved Data Use Agreement (DUA).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Pain Education in people with Burn and Chronic Pain, run by Spaulding Rehabilitation Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey C. Schneider, MD (6179526329, JCSCHNEIDER@MGH.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI Measure (time frame: Baseline and 6 weeks (post-intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07824635, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.