Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy

NCT ID: NCT06269926

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-27

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Many adults with cerebral palsy have chronic pain that interferes with daily activities, but evidence regarding pain treatments for adults with cerebral palsy is limited. In other chronic pain patient populations, behavioral therapies such as cognitive behavioral therapy for chronic pain (CBT-CP) are a key component of evidence-based pain management. This study will assess challenges, implementation barriers, and preliminary efficacy of CBT-CP administered in a virtual group setting for adults with CP to design larger trials to definitively estimate treatment efficacy.

This study will invite 40 adult participants with CP and chronic pain that impacts their life to participate in a trial of CBT-CP. CBT-CP involves weekly group-therapy sessions for 12 weeks. Participants are oriented to CBT and set individualized goals (sessions #1-3) before focusing on cognitive and behavior skill building including physical activity, pacing, relaxation training, and cognitive restructuring (#4-10) then focusing on maintenance and discharge planning (#11-12). Participants will complete surveys every 3 months over a period of 12 months (a total of five surveys before and after CBT-CP). Participants will also continue to receive their usual medical care throughout.

All enrolled participants will receive the CBT intervention. Participants will be randomly assigned to receive CBT either upon enrollment (group 1; CBT\_now) or after a three month delay (group 2; CBT\_later).

This study will be conducted at the Kennedy Krieger Institute in Baltimore, Maryland, USA. Group CBT-CP will be conducted virtually via Zoom. 40 individuals with cerebral palsy who meet all inclusion/exclusion criteria will be recruited in two waves (one in early 2025 and one in early 2026). Participants must be at least 18 years old, able to make informed medical decision for themselves, and must endorse the ability and willingness to participate in all assessment and group sessions regardless of randomization outcome. Participants must also either live in Maryland, or be able to travel to Maryland on a weekly basis for the group therapy sessions.

Conditions

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Cerebral Palsy Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The investigators will randomize 40 adults with cerebral palsy and pain-related impairment in daily activities into two study arms: Group 1 (CBT\_now) will receive Cognitive Behavioral Therapy for Chronic Pain (CBT-CP; the primary intervention-a once weekly, 12-week group therapy course) shortly after enrollment. Group 2 (CBT\_later) will receive CBT-CP after a three month delay. To maintain reasonable therapy cohort sizes (n=10 per cohort), each group (n=20 participants) will consist of two separate therapy cohorts (n=10 each). Participants will be evaluated at the beginning of the study, and then once every 3 months during the 12-month duration of the study.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The team member responsible for efficacy analysis will be blinded to treatment allocation.

Study Groups

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CBT_later

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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Chronic Pain

Intervention Type BEHAVIORAL

CBT-CP consists of skill-based therapy sessions completed weekly for 12 weeks. Participants are oriented to CBT and set individualized goals (sessions #1-3) before focusing on cognitive and behavior skill building including physical activity, pacing, relaxation training, and cognitive restructuring (#4-10) then focusing on maintenance and discharge planning (#11-12). It will be completed in Maryland in an online real-time audio/video virtual group therapy format.

CBT_now

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 Type EXPERIMENTAL

Cognitive Behavioral Therapy for Chronic Pain

Intervention Type BEHAVIORAL

CBT-CP consists of skill-based therapy sessions completed weekly for 12 weeks. Participants are oriented to CBT and set individualized goals (sessions #1-3) before focusing on cognitive and behavior skill building including physical activity, pacing, relaxation training, and cognitive restructuring (#4-10) then focusing on maintenance and discharge planning (#11-12). It will be completed in Maryland in an online real-time audio/video virtual group therapy format.

Interventions

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Cognitive Behavioral Therapy for Chronic Pain

CBT-CP consists of skill-based therapy sessions completed weekly for 12 weeks. Participants are oriented to CBT and set individualized goals (sessions #1-3) before focusing on cognitive and behavior skill building including physical activity, pacing, relaxation training, and cognitive restructuring (#4-10) then focusing on maintenance and discharge planning (#11-12). It will be completed in Maryland in an online real-time audio/video virtual group therapy format.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. At least 18 years of age
2. Has a diagnosis of cerebral palsy
3. Able to send and receive information effectively with familiar communication partners
4. Able, during the consent process, to answer questions about the study to indicate that they understand and consent to participation
5. Has pain that at least moderately interferes with some aspect(s) of their daily activities
6. Able and willing to participate in all assessment and group sessions regardless of randomization outcome
7. Appears on a screening assessment to have enough cognitive ability to recognize their thoughts, feelings, and behaviors to be able to benefit from CBT-CP

Exclusion Criteria

1. Previously received Cognitive Behavioral Therapy (CBT) for chronic pain
2. Endorses that most of their pain is attributable to a recent event (e.g. trauma, surgery that occurred in the past 3 months)
3. Unable to attend weekly CBT-CP sessions from a location in the state of Maryland
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Eric Chin

Assistant Professor of Neurology and Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Chin, M.D

Role: PRINCIPAL_INVESTIGATOR

Kennedy Krieger Institute, Johns Hopkins University

Locations

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Kennedy Krieger Institute

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Paul Salib, B.S

Role: CONTACT

(443) 923-9272

Eric Chin, M.D

Role: CONTACT

443-923-9141

Facility Contacts

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Paul Salib, B.S

Role: primary

(443) 923-9272

Other Identifiers

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IRB00446666

Identifier Type: -

Identifier Source: org_study_id

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