Clinical trial NCT06269926: Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy
Official title: Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Pain, Chronic
Keywords: cerebral palsy
chronic pain
cognitive behavioral therapy
group therapy
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2024-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Data collection achieved (feasibility assessment)
timeFrame: Five assessments (at enrollment and at 3, 6, 9, and 12 months post-enrollment)
Secondary outcomes:
measure: Therapy attendance
timeFrame: Weekly x 12 weeks during therapy administration
measure: Patient Global Impressions of Change
timeFrame: Four assessments (at 3, 6, 9, and 12 months post-enrollment)
measure: Change in Pain Catastrophizing Scale score
timeFrame: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
measure: Change in Pain Self-Efficacy-4 Score
timeFrame: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
measure: Changes in Brief Pain Inventory Pain Interference Subtest scores
timeFrame: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a T-score
timeFrame: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
measure: Changes in Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Kennedy Krieger Institute, Johns Hopkins University
name: Eric Chin, M.D
role: PRINCIPAL_INVESTIGATOR
References: