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Active Not RecruitingNCT06269926

Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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

Interventions

TypeNameDescription
BEHAVIORALCognitive Behavioral Therapy for Chronic PainCBT-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.

Timeline

Start date
2025-02-27
Primary completion
2027-02-01
Completion
2027-02-01
First posted
2024-02-21
Last updated
2026-02-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06269926. Inclusion in this directory is not an endorsement.