Behavioral Insomnia Therapy With Fibromyalgia

纤维肌痛的行为失眠疗法

• 批准号: 7673875
• 负责人: JACK D EDINGER
• 金额: $ 31.68万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-22 至 2012-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7673875
• 关键词: Address; Affect; Aftercare; Antidepressive Agents; Attention; Behavioral; Caring; Chronic; Cognitive; Coping Skills; Data; Education; Electroencephalography; Environment; Etiology; Exercise; Fatigue; Fibromyalgia; Functional disorder; Hygiene; Individual; Intervention; Life Style; Living Wills; Measures; Mediator of activation protein; Monitor; Moods; Occupational; Pain; Patient Self-Report; Patients; Perception; Pharmacotherapy; Pilot Projects; Placebo Control; Play; Polysomnography; Primary Fibromyalgias; Primary Insomnia; Psychological Factors; Quality of life; Randomized; Randomized Clinical Trials; Recommendation; Regression Analysis; Reporting; Research; Research Personnel; Role; Sampling; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Social Functioning; Stress; Symptoms; Testing; Time; Training; Treatment Efficacy; actigraphy; base; chronic widespread pain; clinically significant; cognitive behavior therapy; coping; design; disability; disturbance in affect; fitness; follow-up; health care service utilization; improved; insight; programs; skills training; sleep onset; sleep-focused interventions; standard care; stress management; symptom management; therapy design; treatment as usual; Address; Affect; Aftercare; Antidepressive Agents; Attention; Behavioral; Caring; Chronic; Cognitive; Coping Skills; Data; Education; Electroencephalography; Environment; Etiology; Exercise; Fatigue; Fibromyalgia; Functional disorder; Hygiene; Individual; Intervention; Life Style; Living Wills; Measures; Mediator of activation protein; Monitor; Moods; Occupational; Pain; Patient Self-Report; Patients; Perception; Pharmacotherapy; Pilot Projects; Placebo Control; Play; Polysomnography; Primary Fibromyalgias; Primary Insomnia; Psychological Factors; Quality of life; Randomized; Randomized Clinical Trials; Recommendation; Regression Analysis; Reporting; Research; Research Personnel; Role; Sampling; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Social Functioning; Stress; Symptoms; Testing; Time; Training; Treatment Efficacy; actigraphy; base; chronic widespread pain; clinically significant; cognitive behavior therapy; coping; design; disability; disturbance in affect; fitness; follow-up; health care service utilization; improved; insight; programs; skills training; sleep onset; sleep-focused interventions; standard care; stress management; symptom management; therapy design; treatment as usual

DESCRIPTION (provided by applicant): Fibromyalgia (FM) is a prevalent and debilitating condition characterized by chronic widespread pain, persistent daytime fatigue, sleep disturbances, low mood, loss of stamina, and resultant disability. To date, research has documented the benefits of pharmacotherapy (antidepressants) to manage FM-related pain and mood disturbances and various nonpharmacologic interventions to reduce stress, bolster illness-coping abilities, and increase fitness/stamina. Whereas, most FM patients report chronic sleep disturbances (e.g., delayed sleep onset, fragmented or un-refreshing sleep), the benefits of sleep-focused interventions for FM symptom management have received relatively little research attention. Nevertheless, our recently completed R21 project showed that a cognitive-behavioral insomnia therapy (CBT) is a promising intervention for reducing sleep difficulties and other key symptoms in FM sufferers. Post-hoc analyses suggested that the addition of sleep hygiene (SH) education to CBT strategies might enhance treatment efficacy. Furthermore, pilot regression analyses suggested the usefulness of sleep disturbance measures of as mediators and moderators of FM pain improvement. The project proposed is designed to confirm and extend these findings in a moderately large FM sample. A total of 111 FM patients will be randomized either to a CBT/SH + usual care (DC) condition (n = 37), a Placebo Control (PC) therapy + UC (n = 37) or UC alone (n = 37). Polysomnography conducted before and after eight weeks of treatment and sleep log monitoring and actigraphy conducted before treatment, after treatment, and at a 6-month follow-up will be used to assess sleep improvements. Self-report measures of pain, mood, daytime fatigue, and quality of life will be obtained before, during (mid-treatment), and after treatment and at follow-up to assess changes in other key FM symptoms. Both standard statistical analyses and tests of clinical significance will be used to evaluate the CBT/SH intervention. Additionally, measures extracted from sleep logs, standard scorings of the polysomnograms, and sleep EEG spectral analyses will be considered in regression analyses to identify sleep-based mediators and moderators of improvements in key non-sleep FM symptoms (e.g., pain, fatigue). Results of this trial should provide insights into the pathophysiology and management of FM.

描述（由申请人提供）：纤维肌痛（FM）是一种普遍且令人衰弱的状况，其特征是慢性广泛疼痛，持续的白天疲劳，睡眠不安，情绪低落，情绪低落，耐力丧失和导致的残疾。迄今为止，研究已经记录了药物治疗（抗抑郁药）的好处，以管理与FM相关的疼痛和情绪障碍以及各种非药物干预措施，以减轻压力，增强疾病的能力以及增加适应性/耐力。鉴于大多数FM患者报告了慢性睡眠障碍（例如，睡眠发作延迟，零散或不恢复睡眠），而注重睡眠的干预措施对FM症状管理的好处受到了相对较少的研究注意力。尽管如此，我们最近完成的R21项目表明，认知行为失眠治疗（CBT）是减轻FM患者睡眠困难和其他关键症状的有希望的干预措施。事后分析表明，在CBT策略中增加睡眠卫生（SH）教育可能会增强治疗效率。此外，试点回归分析表明，作为介质和调解器的调解因子的睡眠障碍测量的有用性。该项目旨在确认和扩展这些发现中适中的FM样本。总共111名FM患者将被随机分为CBT/SH +常规护理（DC）条件（n = 37），安慰剂对照（PC）治疗 + UC（n = 37）或单独使用UC（n = 37）。在治疗，治疗前进行的八周治疗和睡眠测量监测和精神分裂症之前和之后进行的多症术术将使用6个月后的随访来评估睡眠改善。自我报告的疼痛，情绪，白天疲劳和生活质量的测量将在（治疗中），治疗后和随访后获得评估其他关键FM症状的变化。标准统计分析和临床意义的测试将用于评估CBT/SH干预。此外，将在回归分析中考虑从睡眠原木，多个多词的标准评分和睡眠脑光谱分析中提取的措施，以鉴定基于睡眠的介体和主持人改善关键的非腿FM症状的改善（例如，疼痛，疲劳，疲劳）。该试验的结果应提供有关FM的病理生理学和管理的见解。