Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy

NCT06269926 | Active Not Recruiting

• 1 other identifier: IRB00446666
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy; Pain, Chronic

Keywords

cerebral palsy; chronic pain; cognitive behavioral therapy; group therapy

Outcome Measures

Primary Outcomes (1)

• Data collection achieved (feasibility assessment)

  We will examine the rate of survey completion for each survey (0 = survey incomplete, 1 = survey complete). Higher scores indicate a better outcome (greater feasibility of recruiting adults with CP and chronic pain and retaining their engagement to complete this clinical trial over a period of 12 months).

  Five assessments (at enrollment and at 3, 6, 9, and 12 months post-enrollment)

Secondary Outcomes (7)

• Therapy attendance

  Weekly x 12 weeks during therapy administration

• Patient Global Impressions of Change

  Four assessments (at 3, 6, 9, and 12 months post-enrollment)

• Change in Pain Catastrophizing Scale score

  Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort

• Change in Pain Self-Efficacy-4 Score

  Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort

• Changes in Brief Pain Inventory Pain Interference Subtest scores

  Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort

Study Arms (2)

CBT_later

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy for Chronic Pain

CBT_now

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy for Chronic Pain

Interventions

Cognitive Behavioral Therapy for Chronic Pain 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_later; CBT_now

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age
• Has a diagnosis of cerebral palsy
• Able to send and receive information effectively with familiar communication partners
• Able, during the consent process, to answer questions about the study to indicate that they understand and consent to participation
• Has pain that at least moderately interferes with some aspect(s) of their daily activities
• Able and willing to participate in all assessment and group sessions regardless of randomization outcome
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Chronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eric Chin, M.D

  Kennedy Krieger Institute, Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The team member responsible for efficacy analysis will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology and Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: February 27, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)