Cognitive Behavioral Therapy for Chronic Pain in Adults with Cerebral Palsy

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

Status: Enrolling

Conditions: Cerebral Palsy; Pain, Chronic

Treatments: Behavioral: Cognitive Behavioral Therapy for Chronic Pain

Study type: Interventional

Funder types: Other

Identifiers

NCT06269926

IRB00446666

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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: (if met then participant will not eligible to participate)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

CBT_later

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Chronic Pain

CBT_now

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Chronic Pain