Patient-Partner Stress Management Effects on CFS Symptoms and Neuroimmune Process

患者伴侣压力管理对慢性疲劳综合症症状和神经免疫过程的影响

• 批准号: 8027426
• 负责人: MICHAEL Howard ANTONI
• 金额: $ 53.63万
• 依托单位: UNIVERSITY OF MIAMI CORAL GABLES
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-16 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8027426
• 关键词: Address; Adrenal Glands; Affect; Anti-Inflammatory Agents; Anti-inflammatory; Attention; Behavioral; Chronic Fatigue Syndrome; Clinical; Cognitive; Diagnosis; Disease; Distress; Economic Burden; Elements; Enrollment; Experimental Designs; Fatigue; Group Structure; Health; Home environment; Hydrocortisone; Hypothalamic structure; Immune; Immune system; Individual; Inflammatory; Interleukin-1 beta; Interleukin-10; Interleukin-13; Interleukin-6; Interleukins; Intervention; Learning; Mental Depression; Modeling; Myalgia; Neuroimmunomodulation; Participant; Patients; Pattern; Pituitary Gland; Population; Randomized; Regulation; Relative (related person); Relaxation; Resources; Salivary; Sleep; Social support; Societies; Stress; Structure; Subgroup; Symptoms; System; Techniques; Telecommunications; Telephone; Testing; Time; Time Factors; Travel; Tumor Necrosis Factor-alpha; Tumor Necrosis Factors; Unemployment; base; burden of illness; cytokine; design; disability; follow-up; group intervention; health care service utilization; hypothalamic-pituitary-adrenal axis; immunoregulation; improved; innovation; intervention effect; psychosocial; public health relevance; randomized trial; skill acquisition; skills; skills training; social; stress management; theories

DESCRIPTION (provided by applicant): This is a 5-year study to evaluate the effect of a 10-week patient-partner telephone- based cognitive behavioral stress management (CBSM) intervention on chronic fatigue syndrome (CFS) symptoms in 150 patients diagnosed with CFS. Because many patients with CFS are unable to attend intervention sessions in clinical settings due to unpredictable periods of debilitating fatigue and limited mobility, we created a form of CBSM intervention that is delivered at the participant's home through a telecommunications system (i.e., Telephone-based CBSM, T-CBSM). A unique aspect of T-CBSM is that it uses the telephone to convene groups of individuals in their homes-thus it retains some of the supportive elements of a group-based intervention. We have observed that over a 5-month period this patient-focused T-CBSM intervention is associated with decreases in CDC-based CFS symptoms and decreases in the pro- inflammatory cytokines, interleukin-1b (IL-1b) and tumor necrosis factor-a (TNF-a) and increases in the anti-inflammatory cytokine, IL-13. Greater decreases in pro- inflammatory cytokines were associated with greater increases in the negative pitch of the AM-PM slope of salivary cortisol and greater decreases in CFS symptoms. This supported our neuroimmune model as an explanation for the effects of T-CBSM on CFS symptoms. We also conducted subgroup analyses comparing partnered and unpartnered CFS patients and found that the effects of the intervention were much larger in the partnered group. We have designed a study to follow up on these findings by testing a newly designed partner-patient dual focus videotelephone-delivered CBSM intervention (PP-T-CBSM) that allows the partner to learn stress management techniques with the patient in a group setting and to then practice together a set of stress management techniques such as relaxation and cognitive, behavioral and interpersonal skills training. We will compare changes in CFS symptoms, neuroimmune indicators, and psychosocial (patient and partner) functioning in participants assigned to PP-T-CBSM vs an attention time-matched telephone-based health information (T-HI) control condition in a 2 X 3 randomized experimental design with group (PP-T-CBSM, n=75 vs. T-HI, n=75) as the between-group factor, and time (Pre-intervention, 5- and 9- month follow-up) as the within-group factor. PUBLIC HEALTH RELEVANCE: Because chronic fatigue syndrome (CFS) is a debilitating condition, that has no cure, and which represents an economic burden for society due to high rates of unemployment due to disability and repeated utilization of healthcare resources it is critical that interventions target long-term management by addressing the multi-level factors that maintain the symptoms of this disorder. The results of this study have major significance since they might offer an intervention that is efficacious in managing CFS symptoms through a theory-based comprehensive stress management approach, and one that will reach a broader population of CFS patients who would not otherwise be able to benefit from these empirically supported techniques. The proposed study is innovative in being the first randomized trial to test the effects of a patient-partner Video- Telephone-delivered psychosocial intervention (PP-T-CBSM) for CFS patients while examining a neuroimmune mechanism (hypothalamic-pituitary-adrenal [HPA] axis-cytokine regulation) to explain the effects of this intervention on CFS symptoms.

描述（由申请人提供）：这是一项为期5年的研究，旨在评估10周患者 - 基于电话的认知行为应力管理（CBSM）干预对150名诊断为CFS的患者的慢性疲劳综合征（CFS）症状的影响。由于许多CFS患者由于无法预测的使人衰弱的疲劳和有限的流动性而无法在临床环境中参加干预课程，因此我们创建了一种CBSM干预的形式，该形式通过电信系统（即基于电话的CBSM CBSM，T-CBSM，T-CBSM）在参与者的家中提供。 T-CBSM的一个独特方面是，它使用电话在其家中召集个人组成的人群 - 因此，它保留了基于组的干预措施的一些支持元素。我们已经观察到，在5个月的时间内，这种以患者为中心的T-CBSM干预措施与CDC的CFS症状降低有关，并且促炎性细胞因子的降低和降低，白介素1B（IL-1B）（IL-1B）和肿瘤坏死因子-A（TNF-A）（TNF-A）（TNF-A）（TNF-A），并增加抗抗抑制性Cytokine cytokine cytokine cytokine cytokine cytokine cytokine cytokine cytokine cytokine cytokine cytokine cytokine cy33。促炎性细胞因子的较大降低与唾液皮质醇的AM-PM斜率的负斜率增加有关，而CFS症状的降低较大。这支持了我们的神经免疫模型，以解释T-CBSM对CFS症状的影响。我们还进行了亚组分析，比较了合作和未解决的CFS患者，并发现伙伴组的干预效果要大得多。我们设计了一项研究来跟进这些发现，通过测试新设计的合作伙伴患者双重焦点录像带录像带CBSM干预措施（PP-T-CBSM），该研究使伴侣能够与患者在小组设置中学习压力管理技术，然后一起练习一系列的压力管理技术，例如放松，行为，行为，培训和培训技能。我们将比较分配给PP-T-T-CBSM的参与者中的CFS症状，神经免疫指标以及心理社会（患者和伴侣）的功能，与注意力相匹配的基于电话的健康信息（T-HI）的健康信息（T-HI）控制条件在2 x 3随机实验设计中使用组（PP-T-CBSM，pp-t-cbsm，n = 75 vs. t-in = 75），n = 75，n = 75），（n = 75）（n = 75）（n = 75）（n = 75）（n = 75）（n = 75）（n = 75）（n = 75）（n = 75）， 9个月的随访）作为组内因子。 公共卫生相关性：因为慢性疲劳综合症（CFS）是一种使人衰弱的状况，无法治愈，并且由于残疾而导致的失业率高，这代表了社会的经济负担，因此由于医疗资源的反复利用而导致的失业率高，因此至关重要的是，至关重要的是，干预措施通过维持该疾病症状的多层因素来解决多重级别的因素，这一点至关重要。这项研究的结果具有重要意义，因为它们可能会提供一种干预措施，该干预措施通过基于理论的综合压力管理方法有效地管理CFS症状，而这种方法将达到更广泛的CFS患者，而CFS患者否则将无法从这些经验支持的技术中受益。拟议的研究具有创新性，是第一个随机试验，用于检验CFS患者的患者 - 伴侣视频电话传递的心理社会干预（PP-T-CBSM），同时检查神经免疫性机制（下丘脑 - 丘脑 - 上核肾上腺肾上腺 - 肾上腺腺癌[HPA] Axis-cytokine [HPA] Axis-Cytokine调节）对这种效果的效果对CFS的效果进行了效果。