Longitudinal Determination of Outcomes of Adolescents with Fibromyalgia

青少年纤维肌痛结局的纵向测定

• 批准号: 7661999
• 负责人: Susmita Kashikar-Zuck
• 金额: $ 41.36万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-01 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7661999
• 关键词: 15 year old; 19 year old; Achievement; Adolescence; Adolescent; Adult; Affect; Age; Anti-Inflammatory Agents; Anti-inflammatory; Antidepressive Agents; Anxiety; Anxiety Disorders; Arts; Caring; Childhood; Chronic; Clinical; Clinical Trials; Comorbidity; Complex; Country; DSM-IV; Data; Data Set; Development; Diagnosis; Disabled Persons; Disease; Disease remission; Distress; Dose; Early Diagnosis; Early identification; Early treatment; Educational Status; Emotional; Enrollment; Exercise; Family; Family member; Fatigue; Feeling suicidal; Fibromyalgia; Future; Goals; Guidelines; Impairment; Individual; Intervention; Interview; Investigation; Knowledge; Life; Long-Term Effects; Longitudinal Studies; Medical; Methods; Mood Disorders; Moods; Morbidity - disease rate; Outcome; Pain; Participant; Patient Care; Patients; Persistent pain; Persons; Pharmaceutical Preparations; Physical Function; Positioning Attribute; Prevalence; Preventive Intervention; Primary Fibromyalgias; Process; Prospective Studies; Protocols documentation; Quality of life; Recommendation; Relative (related person); Reporting; Research; Resources; Rheumatology; Risk; Schools; Severities; Sleep; Social Functioning; Social Problems; Specific qualifier value; Stress; Stress and Coping; Subgroup; Surveys; Symptoms; Syndrome; Techniques; Testing; Time; Tricyclic Antidepressive Agents; Work; accomplished suicide; base; chronic pain; clinical care; clinically relevant; cognitive behavior therapy; cohort; coping; daily functioning; depression; depressive symptoms; design; disability; emerging adult; experience; functional disability; improved; interdisciplinary approach; longitudinal course; meetings; outcome forecast; peer; primary outcome; prospective; psychosocial; public health relevance; research study; response; skills; social; standard of care; symptom management; young adult

DESCRIPTION (provided by applicant): Fibromyalgia syndrome (FMS) is a chronic and often debilitating condition that results in marked difficulties in daily functioning, psychiatric comorbidity and decreased quality of life. Many adult FMS patients report that their symptoms began earlier in life, when the symptoms may have been more amenable to early intervention. However, the developmental course of FMS and its associated symptoms from adolescence through adulthood has never been documented. Prospective longitudinal studies of patients diagnosed with fibromyalgia in adolescence are urgently needed. In this study, we propose to prospectively follow 96 patients diagnosed with juvenile primary fibromyalgia syndrome (JPFS) and 48 healthy controls into their young adult years. These participants are currently enrolled in our completed and ongoing JPFS research, and have completed baseline assessment (Time 1, Mean age 15 years). A Time 2 protocol has been recently implemented to assess current functioning (Mean age 19 years). So far we have demonstrated excellent cohort retention (90%), and preliminary results suggest that as a group, JPFS patients continue to have significant physical and emotional difficulties, but there is considerable variability in outcomes. Participants are now approaching the crucial young adult years, a time of rapid change and new challenges that places greater stress on coping resources for those who are already dealing with chronic pain. We are proposing two additional assessments for the entire cohort in the young adult years (Time 3, Mean Age = 22 years; and Time 4, Mean Age = 24 years). In this controlled, prospective longitudinal study, the primary objective is to first establish whether JPFS patients continue to have greater physical symptoms and impairment, psychiatric symptoms and social difficulties in young adulthood than healthy controls. The secondary objective is to examine developmental trajectories of two key outcomes: physical impairment and depressive symptoms, from adolescence through young adulthood. For each outcome, we hypothesize three distinct trajectories: those who show low initial impairment and continue to show little impairment into young adulthood, those who are initially impaired and get worse over time, and those who are initially impaired but improve over time. We will test whether trajectories of physical impairment and depressive symptoms are independent of one another, and in doing so, we will be able to disentangle aspects of mood from impairment associated with FMS. Moreover, we will test whether change in FMS symptom severity is differentially associated with physical impairment or depressive symptoms. Finally, we will test whether treatment via cognitive-behavioral therapy in adolescence has any persisting effects on long-term outcomes. Information will be gathered from participants and family member/ significant others via on-line surveys. Psychiatric interviews and tender point exams will be conducted in person. The long-term goal is to develop more refined methods to identify patients who are at risk for negative trajectories of physical and emotional outcomes and to design early, targeted interventions. PUBLIC HEALTH RELEVANCE: This project will be the first controlled prospective longitudinal study of adolescents with JPFS. The results will greatly increase our knowledge about the prognosis for patients with JPFS, and the complex relationship between physical and emotional symptoms in fibromyalgia syndrome. Findings will be of direct clinical relevance with respect to knowledge about physical, emotional and social outcomes for JPFS patients, and early identification of those who may be at risk for long term suffering and disability. The study will lay the groundwork for future clinical trials aimed at early and targeted interventions for JPFS.

描述（由申请人提供）：纤维肌痛综合征（FMS）是一种慢性且通常使人衰弱的疾病，可导致日常功能明显困难、精神并发症和生活质量下降。许多成年FMS患者报告说，他们的症状在生命早期就开始了，当时症状可能更适合早期干预。然而，从青春期到成年期的FMS及其相关症状的发展过程从未被记录。目前迫切需要对青春期纤维肌痛患者进行前瞻性纵向研究。在这项研究中，我们计划前瞻性地随访96例诊断为青少年原发性纤维肌痛综合征（JPFS）的患者和48例健康对照者。这些受试者目前已入组我们已完成和正在进行的JPFS研究，并已完成基线评估（时间1，平均年龄15岁）。最近实施了Time 2方案来评估当前功能（平均年龄19岁）。到目前为止，我们已经证明了良好的队列保留率（90%），初步结果表明，作为一个群体，JPFS患者继续有显着的身体和情绪困难，但有相当大的变化的结果。参与者现在正在接近关键的年轻成年人，这是一个快速变化和新挑战的时代，对那些已经在处理慢性疼痛的人来说，应对资源的压力更大。我们建议在年轻成年人中对整个队列进行两次额外评估（时间3，平均年龄= 22岁;时间4，平均年龄= 24岁）。在这项对照的前瞻性纵向研究中，主要目的是首先确定JPFS患者在青年期是否比健康对照组继续具有更大的身体症状和损伤，精神症状和社交困难。第二个目标是检查两个关键结果的发展轨迹：从青春期到青年期的身体损伤和抑郁症状。对于每一种结果，我们假设三种不同的轨迹：那些表现出低初始损伤并继续表现出轻微损伤到年轻的成年人，那些最初受损并随着时间的推移而恶化的人，以及那些最初受损但随着时间的推移而改善的人。我们将测试身体损伤和抑郁症状的轨迹是否相互独立，这样做，我们将能够从与FMS相关的损伤中分离出情绪的各个方面。此外，我们将测试FMS症状严重程度的变化是否与身体损害或抑郁症状有差异。最后，我们将测试在青春期通过认知行为疗法进行治疗是否对长期结果有任何持续的影响。信息将通过在线调查从参与者和家庭成员/重要他人那里收集。精神科面试和招标点考试将亲自进行。长期目标是开发更精确的方法来识别有身体和情绪结果负面轨迹风险的患者，并设计早期有针对性的干预措施。公共卫生相关性：该项目将是第一项针对青少年JPFS的前瞻性纵向对照研究。这些结果将大大增加我们对JPFS患者预后的了解，以及纤维肌痛综合征中身体和情感症状之间的复杂关系。研究结果将与JPFS患者的身体，情绪和社会结果的知识直接临床相关，并早期识别那些可能有长期痛苦和残疾风险的人。该研究将为未来的临床试验奠定基础，旨在对JPFS进行早期和有针对性的干预。