Cognitive Behavioral Therapy for Chronic Pain in Cerebral Palsy

Overseen By Eric Chin, M.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Disqualifiers: Prior CBT, Recent trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 17

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cognitive behavioral therapy (CBT), a type of talk therapy, can help adults with cerebral palsy manage chronic pain through virtual group sessions. Participants will divide into two groups: one starts therapy soon after joining, and the other begins three months later. The study seeks adults with cerebral palsy whose pain significantly affects daily activities and who haven't tried CBT for pain before. As an unphased trial, it offers participants the opportunity to explore a potentially beneficial therapy for managing chronic pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Cognitive Behavioral Therapy for Chronic Pain is safe for adults with cerebral palsy and chronic pain?

Research has shown that cognitive behavioral therapy (CBT) for chronic pain is generally safe. Studies have found that participants often experience improvements in anxiety, depression, and catastrophic thinking, which involves expecting the worst. This suggests that CBT is usually well-tolerated. Available studies report no serious side effects or harmful events from using CBT for chronic pain. While it might not reduce the pain itself, the positive effects on mental health are clear. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Behavioral Therapy (CBT) for managing chronic pain in individuals with cerebral palsy because it offers a non-drug approach focused on changing pain-related thoughts and behaviors. Unlike conventional treatments that often involve medication like analgesics or physical therapy, CBT empowers patients with skills to manage their pain psychologically. This method could reduce dependency on pain medications and improve overall quality of life by addressing the mental and emotional aspects of chronic pain. Additionally, CBT can be tailored to each individual, making it a versatile option that could potentially provide long-lasting benefits.

What evidence suggests that Cognitive Behavioral Therapy for Chronic Pain might be an effective treatment for chronic pain in cerebral palsy?

Research has shown that Cognitive Behavioral Therapy (CBT) can be adapted for individuals with cerebral palsy (CP) to manage long-term pain. Studies have found that CBT for chronic pain can reduce extreme negative thinking, depression, anxiety, and disability. This therapy works by changing negative thoughts and actions that exacerbate pain. Although most CBT studies for CP have focused on mental health issues, its use for chronic pain appears promising due to its success in other conditions. Early results suggest that CBT could effectively manage chronic pain in people with CP. Participants in this trial will receive Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) either shortly after enrollment or approximately three months later, allowing researchers to compare the timing effects on treatment outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Eric Chin, M.D

Principal Investigator

Kennedy Krieger Institute, Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults with cerebral palsy who experience chronic pain. Participants should be interested in learning new ways to manage their pain through therapy and education.

Inclusion Criteria

Shows developmental readiness to benefit from CBT via the Behavior, Thought, Feeling Questionnaire (BTFQ)

I have been diagnosed with cerebral palsy.

I am willing and able to attend all study sessions, no matter the group I'm assigned to.

Exclusion Criteria

I have undergone CBT for chronic pain before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) in weekly virtual group sessions

12 weeks

12 virtual group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment through surveys

12 months

5 surveys (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Chronic Pain

Trial Overview

The study is testing whether cognitive behavioral therapy, along with pain education, can help change how people think about their pain and reduce the impact it has on their lives.

How Is the Trial Designed?

Group I: CBT_now Experimental Treatment 1 Intervention

The CBT\_now group will receive Cognitive Behavioral Therapy for Chronic Pain (CBT-CP; the primary intervention-a 12-week group therapy course) beginning shortly after enrollment.

Group II: CBT_later Experimental Treatment 1 Intervention

The CBT\_later group will receive Cognitive Behavioral Therapy for Chronic Pain (CBT-CP; the primary intervention-a 12-week group therapy course) beginning approximately 3 months after enrollment.

Cognitive Behavioral Therapy for Chronic Pain is already approved in United States for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Chronic Pain for:

• Chronic pain management in veterans with serious mental illness

Who Is Running the Clinical Trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Lead Sponsor

Trials

93

Recruited

25,200+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

In a study of 50 adults with cerebral palsy (CP) and chronic pain, coping strategies like pain-contingent rest and catastrophizing were linked to greater pain interference and depressive symptoms, even when accounting for pain severity.

These results suggest that cognitive-behavioral approaches could be beneficial for managing chronic pain in individuals with CP, highlighting the need for further research on interventions that teach effective coping strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain in cerebral palsy: the relation of coping strategies to adjustment. Engel, JM., Schwartz, L., Jensen, MP., et al.[2021]

A study involving 278 patients with chronic back pain found that an AI-driven cognitive behavioral therapy for chronic pain (AI-CBT-CP) was noninferior to standard telephone CBT-CP, showing similar effectiveness in reducing disability and pain over 6 months.

AI-CBT-CP not only achieved better clinical outcomes for patients but also required less than half the therapist time compared to traditional CBT-CP, suggesting it could improve access to treatment for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. Piette, JD., Newman, S., Krein, SL., et al.[2023]

A study of 205 adults with cerebral palsy revealed that chronic pain is prevalent, particularly in the back and weight-bearing joints, and affects individuals across different functional levels without significant differences in pain severity based on age or mobility classification.

Chronic pain was linked to higher levels of depression and lower satisfaction with social roles and physical function, indicating that addressing pain could improve overall quality of life for adults with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adults with cerebral palsy and chronic pain experience: A cross-sectional analysis of patient-reported outcomes from a novel North American registry. Sarmiento, CA., Gannotti, ME., Gross, PH., et al.[2023]

A pilot study involving 10 children with cerebral palsy showed that the BrightHearts app for biofeedback-assisted relaxation training is an acceptable and feasible tool for managing chronic pain, with many participants finding it a valuable addition to their pain management strategies.

While the study did not find significant reductions in pain or anxiety scores, most children reported positive experiences and would recommend the app to others, indicating its potential as part of a multimodal approach to pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BrightHearts: A pilot study of biofeedback assisted relaxation training for the management of chronic pain in children with cerebral palsy. Ostojic, K., Sharp, N., Paget, S., et al.[2022]

The RESOLVE trial is a large-scale, 3-arm randomized control trial designed to compare the effectiveness of telephonic/video and online CBT for chronic pain against usual care, involving diverse populations across urban and rural areas.

This study aims to assess not only the clinical effectiveness of these CBT interventions in reducing pain severity but also their cost-effectiveness, potentially improving access to treatment for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. Mayhew, M., Balderson, BH., Cook, AJ., et al.[2023]

Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) shows promising effectiveness in primary care settings, with significant improvements in pain intensity and functional limitations observed by the third appointment among 118 patients.

The most effective components of Brief CBT-CP included psychoeducation, goal setting, pacing, and relaxation training, suggesting that these strategies are beneficial for managing chronic pain without relying on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Cognitive Behavioral Therapy For Chronic Pain: Results From a Clinical Demonstration Project in Primary Care Behavioral Health. Beehler, GP., Murphy, JL., King, PR., et al.[2020]

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