Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain: Promoting Engagement in Cognitive Behavioral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 470
- 试验地点
- 27
- 主要终点
- Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain interference for AYAs with SCD and chronic pain
研究概览
简要总结
The study, known as the Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy (PRESENCE), aims to determine the effectiveness of digital CBT in reducing pain, opioid use, and healthcare utilization among AYAs with SCD. It also seeks to understand the role of personalized peer support in enhancing engagement and outcomes of digital CBT interventions.
By leveraging existing infrastructure for delivering virtual peer support interventions, tailored digital CBT programs for individuals with SCD, and partnerships with CBOs, the study aims to provide valuable insights into the feasibility and effectiveness of digital CBT as a pain management strategy for this vulnerable population.
详细描述
The PRESENCE study aims to address the pressing issue of inadequate pain management for adolescents and young adults (AYAs) with sickle cell disease (SCD). Despite pain being the primary clinical symptom of SCD, effective treatment options are limited, leading to repeated hospitalizations and negative impacts on patients' physical and mental well-being. Opioids, the primary treatment for chronic SCD pain, often fail to provide long-term relief and can result in harmful consequences.
Recognizing the need for alternative approaches, the study hopes to investigate the effectiveness of digital cognitive behavioral therapy (CBT), both with and without personalized peer support delivered through community-based organizations (CBOs). CBT is a well-established method for managing pain in the general population, and digital CBT has shown promise in improving outcomes for individuals with chronic conditions.
The study will involve a multisite, randomized controlled trial with 470 AYAs with SCD who have experienced frequent pain over the past three months. Participants will be randomized into one of three groups:
- Digital CBT with weekly one-on-one peer support (CBT+peer)
- Digital CBT without peer support (self-guided CBT)
- Usual care (UC)
The primary hypotheses of the study are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 16 to 30 years of age at time of enrollment
- •Sickle Cell Disease diagnosis of any genotype based on referral or documentation
- •Reports chronic pain (≥4 days/week for past 3 months or more) OR A) Being prescribed pain medication to be taken (≥4 days/week for past 3 months or more) OR B) Taking pain medication (≥4 days/week for past 3 months or more) OR C) Receiving non-pharmaceutical pain treatment (≥4 days/week for past 3 months or more)
- •Access to an iOS or Android mobile device with internet access
排除标准
- •Unable to speak or read English
- •Prior hematopoietic stem cell transplant for sickle cell disease
研究组 & 干预措施
CBT w/ Health Coach
Group will utilize the Presence app to undergo self CBT for EMA, but with addition of peer health coaches.
干预措施: CBT+ Health coach (Behavioral)
CBT w/o Health coach (self-guided)
Group will utilize the Presence app to undergo self-guided CBT for EMA, but without peer health coaches.
干预措施: CBT w/o Health Coach ( self-guided) (Behavioral)
Usual Care with no access to CBT
Participants in the UC group will have access to CaRISMA app to complete a daily pain and mood e-diary, daily record of opiate use, and weekly assessment of pain via the Painimation tool. All other care will be at the discretion of their treating provider
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain interference for AYAs with SCD and chronic pain
时间窗: Baseline and 6 months
Mean change in pain interference as measured by the PEG-3 items 2 and 3 that ask individuals to rate how pain has interfered with their enjoyment and general activities, in the past week, using a 0-10 rating scale.
Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain intensity for AYAs with SCD and chronic pain
时间窗: Baseline and 6 months
Mean change in pain intensity as measured by the Pain, Enjoyment of Life and General Activity (PEG-3) scale. Item 1 asks individuals to rate their pain, on average, over the past week, using a 0-10 rating scale.
次要结局
- Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain interference for AYAs with SCD and chronic pain(Baseline and 6 months)
- Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain intensity for AYAs with SCD and chronic pain(Baseline and 12 months)
- Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain interference for AYAs with SCD and chronic pain(Baseline and 12 months)
- Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain intensity of AYAs with SCD and chronic pain(Baseline and 12 Months)
- Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain intensity for AYAs with SCD and chronic pain(Baseline and 6 months)
- Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain interferences of AYAs with SCD and chronic pain(Baseline and 12 Months)
研究者
Charles Jonassaint
Associate Professor
University of Pittsburgh