Neurobiology of Pain in Burn Survivors

NCT07824635 | Not Yet Recruiting DMC

• 1 other identifier: 2026P001589
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Burn; Chronic Pain; Pain Catastrophizing

Keywords

Burn Injury; Cognitive Behavioral Therapy; fMRI

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (2)

• Pain Catastrophizing Scale (PCS)

  Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up).

• Brief Pain Inventory (BPI)

  Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up)

Other Outcomes (5)

• Patient-Reported Outcomes Measurement Information System (PROMIS-29)

  Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up).

• Quantitative Sensory Testing (QST) Battery

  Baseline, and 6 weeks (post-intervention).

• Coping Strategies Questionnaire

  Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up)

Study Arms (2)

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.

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.

Behavioral: Pain Education

Interventions

Cognitive Behavioral Therapy 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).

Cognitive Behavioral Therapy

Pain Education BEHAVIORAL

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.

Pain Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

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MeSH Terms

Conditions

Burns; Chronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Jeffrey C. Schneider, MD

CONTACT

6179526329; JCSCHNEIDER@MGH.HARVARD.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard Medical School

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share