Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Data collection achieved (feasibility assessment)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The team member responsible for efficacy analysis will be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •(if met then participant will not eligible to participate)
- •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
研究组 & 干预措施
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.
干预措施: Cognitive Behavioral Therapy for Chronic Pain (Behavioral)
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.
干预措施: Cognitive Behavioral Therapy for Chronic Pain (Behavioral)
结局指标
主要结局
Data collection achieved (feasibility assessment)
时间窗: Five assessments (at enrollment and at 3, 6, 9, and 12 months post-enrollment)
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).
次要结局
- 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)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a T-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 Patient Health Questionnaire-4 (PHQ-4)(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)
研究者
Eric Chin
Assistant Professor of Neurology and Pediatrics
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.