Behavioral Interventions and Long Term Outcomes in Juvenile Fibromyalgia Syndrome

描述(申请人提供)：本次职业生涯中期研究人员奖续签申请的具体目标是：1)成功实施一项持续的前瞻性纵向研究以确定青少年纤维肌痛(JFM)儿童患者的长期疗效；2)完善和测试一项新的干预措施，即认知行为疗法(CBT)和体育锻炼相结合，以减少青少年纤维肌痛患者的疼痛和损害，增加其应对能力和体力活动；3)继续使用候选人正在进行和计划中的儿科疼痛临床研究来培训博士后研究员和初级教员。候选人S是国家认可的儿科疼痛研究员，拥有10年独立资助面向患者的研究历史，专注于JFM和其他疼痛状况的行为治疗临床试验、纵向研究和早期职业研究人员的指导。在她目前K24基金的前3.5年里，她完成了第一个严格对照的试验，证明CBT是JFM中减少残疾和抑郁的安全有效的干预措施，她发表了22篇基于她的JFM和儿科疼痛研究的论文(与她的受试者一起)。这一续签申请的拟议研究计划包括两个项目：1)正在进行的NIAMS(R01)资助的关于患有JFM的青少年长期结果的纵向研究，以及2)正在进行的CBT和运动适应青少年(青少年纤维肌痛综合训练)联合干预的试点试验。这一新计划的创新之处在于，它建立在候选人已建立的CBT计划的基础上，并无缝地整合了从运动药物/伤害预防修改而来的运动成分，以改善身体力学，增加体力活动，而无需担心疼痛症状和活动避免，这是JFM患者不活动的核心。结果将通知JFM的下一次多站点随机对照试验。指导计划是在儿科慢性疼痛的临床试验和结果研究领域培训未来的临床研究人员。候选人的计划包括1)由目前资助的研究支持的对博士后研究员/初级教员的个性化指导(纵向研究 JFM(R01)，PROMIS在儿科疼痛和风湿学(U01)，儿科偏头痛预防药物的40个站点的临床试验(U01)，以及其他正在进行的研究，2)指导研究员/教职员工发展他们自己的独立研究，3)研究员参与既定的教学项目，关于手稿/赠款的撰写，研究方法和负责任的人类研究行为。辛辛那提儿童医院为这一奖项提供了一个理想的环境，因为它为以患者为中心的研究和团队科学提供了强有力的机构支持，存在获奖的慢性疼痛计划，与对儿科疼痛感兴趣的儿科风湿学、止痛药、运动医学和神经学研究人员进行了强有力的跨学科研究合作，分区数据核心，以及该机构致力于为儿科患者“改变结果”。

DESCRIPTION (provided by applicant): The Specific Aims of this Midcareer Investigator Award renewal application are to 1) successfully implement an ongoing prospective longitudinal study to determine long term outcomes of pediatric patients with juvenile- onset fibromyalgia (JFM), 2) to refine and test a novel intervention, i.e., combined cognitive-behavioral therapy (CBT) and physical exercise to reduce pain and impairment, and increase coping and physical activity in adolescents with JFM, and 3) continue to use the candidate's ongoing and planned clinical studies in pediatric pain to train postdoctoral fellows and junior faculty. The Candidate s a nationally recognized pediatric pain researcher with a history of >10 years of independently funded patient-oriented research focused on clinical trials of behavioral treatment for JFM and other pain conditions, longitudinal studies, and mentorship of early career researchers. In the first 3.5 years of her current K24 funding, she completed the first rigorously controlled trial demonstrating that CBT is a safe and effective intervention for reduction of disability and depression in JFM and she published 22 papers (along with her mentees) based on her JFM and pediatric pain research. The proposed Research Plan for this renewal application includes two projects: 1) an ongoing NIAMS (R01) funded longitudinal study of long-term outcomes of adolescents with JFM, and 2) an ongoing pilot trial of a novel combined CBT and exercise - FIT Teens (Fibromyalgia Integrative Training for Teens) intervention. The innovation of this new program is that it builds on the candidate's established CBT program and seamlessly integrates an exercise component modified from sports-medicine/injury prevention to improve body mechanics and increase physical activity without fear of pain-flares and activity avoidance which is central to inactivity in JFM patients. Results will inform the next multi-site RCT in JFM. The Mentoring Plan is to train future clinical investigators in the field of clinical trials and outcoms research in pediatric chronic pain. The candidate's plan consists of 1) individualized mentoring of postdoctoral fellows/junior faculty supported by currently funded studies (longitudinal study in JFM (R01), PROMIS in pediatric pain and rheumatology (U01), a 40-site clinical trial of prevention medication for pediatric migraine (U01), and other ongoing studies, 2) mentoring of fellows/faculty to develop their own independent research and 3) participation of fellows in established didactic programs on manuscript/grant writing, research methodology and responsible conduct of human research. Cincinnati Children's provides an ideal setting for this award because of the strong institutional support for patient-oriented research and team-science, presence of an award winning chronic pain program, strong interdisciplinary research collaborations with pediatric rheumatology, pain medicine, sports medicine and neurology researchers interested in pediatric pain, a divisional data core and a commitment of the institution to "change the outcomes" for pediatric patients.