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

Trial Summary

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 data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Chronic Pain in managing chronic pain in cerebral palsy?

Research shows that cognitive-behavioral therapy (CBT) is effective for managing chronic pain in general, and it may help people with cerebral palsy by teaching them better coping strategies to reduce pain interference and depressive symptoms. Although specific studies on CBT for chronic pain in cerebral palsy are limited, the general effectiveness of CBT for chronic pain suggests it could be beneficial for this group as well. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Chronic Pain safe for humans?

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is considered a safe treatment for managing chronic pain and is an alternative to using opioid painkillers. ^{1 2 3 4 6}

How is Cognitive Behavioral Therapy for Chronic Pain different from other treatments for chronic pain in cerebral palsy?

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is unique because it focuses on teaching patients coping strategies to manage pain, which can help reduce depressive symptoms and pain interference. Unlike other treatments that may focus on medication or physical interventions, CBT-CP is a psychological approach that can be delivered remotely, making it more accessible to those in rural or underserved areas. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to understand if cognitive behavioral therapy can feasibly be provided to groups of adults with cerebral palsy and chronic pain via virtual group therapy sessions.

Research Team

Eric Chin, M.D

Principal Investigator

Kennedy Krieger Institute, Johns Hopkins University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pain in cerebral palsy: the relation of coping strategies to adjustment. [2021]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Brief Cognitive Behavioral Therapy For Chronic Pain: Results From a Clinical Demonstration Project in Primary Care Behavioral Health. [2020]

4. United States 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. [2023]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. [2023]