Behavioral Interventions and Long Term Outcomes in Juvenile Fibromyalgia Syndrome

描述（由申请人提供）：本次中期研究者奖续期申请的具体目标是：1)成功实施一项正在进行的前瞻性纵向研究，以确定青少年纤维肌痛（JFM）儿童患者的长期预后；2)完善和测试一种新的干预措施，即认知行为疗法（CBT）和体育锻炼相结合，以减轻青少年纤维肌痛的疼痛和损害，并增加应对能力和体育活动。3)继续利用候选人在儿科疼痛方面正在进行和计划进行的临床研究来培养博士后和初级教师。候选人是全国公认的儿科疼痛研究人员，拥有10年独立资助的以患者为导向的研究历史，专注于JFM和其他疼痛状况的行为治疗临床试验，纵向研究，以及早期职业研究人员的指导。在她目前的K24资助的前三年半里，她完成了第一个严格控制的试验，证明CBT是一种安全有效的干预措施，可以减少JFM患者的残疾和抑郁，她发表了22篇论文（与她的学生一起）基于她的JFM和儿科疼痛研究。这项更新申请的研究计划包括两个项目：1)正在进行的NIAMS （R01）资助的JFM青少年长期结果的纵向研究，2)正在进行的新型CBT和运动结合的试点试验- FIT青少年（青少年纤维肌痛综合训练）干预。这个新项目的创新之处在于，它建立在候选人已建立的CBT项目的基础上，并无缝地整合了从运动医学/伤害预防中改进的运动成分，以改善身体力学，增加身体活动，而不必担心疼痛发作和活动逃避，这是JFM患者缺乏活动的核心。结果将通知JFM的下一个多点随机对照试验。该指导计划旨在培养儿童慢性疼痛临床试验和结果研究领域的未来临床研究者。候选人的计划包括1)对博士后/初级教师进行个性化指导，并由当前资助的研究（纵向研究）支持

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.