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

描述(申请人提供)：这是一项为期5年的研究，旨在评估为期10周的患者-伴侣电话认知行为应激管理(CBSM)干预对150名确诊为慢性疲劳综合征(CFS)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衰弱疲劳期和活动受限而无法在临床环境中参加干预会议，我们创建了一种形式的CBSM干预，通过电信系统在参与者家中提供(即，基于电话的CBSM，T-CBSM)。T-CBSM的一个独特方面是，它使用电话在家中召集个人团体-因此，它保留了基于团体的干预的一些支持性元素。我们观察到，在5个月的时间里，这种以患者为中心的T-CBSM干预与基于CDC的CFS症状的减少和促炎细胞因子IL-1b(IL-1b)和肿瘤坏死因子-a(TNF-a)的减少以及抗炎细胞因子IL-13的增加有关。促炎症细胞因子的减少越多，唾液皮质醇AM-PM斜率的负音高越大，CFS症状的减少越多。这支持我们的神经免疫模型作为T-CBSM对CFS症状影响的解释。我们还进行了亚组分析，比较了配对和非配对的CFS患者，发现在配对的组中干预的效果要大得多。我们设计了一项研究，通过测试新设计的伴侣-患者双焦点视频电话传递的CBSM干预(PP-T-CBSM)来跟踪这些发现，该干预允许伴侣在小组环境中与患者学习压力管理技术，然后一起练习一套压力管理技术，如放松以及认知、行为和人际技能训练。我们将采用2×3随机实验设计，以组内因素(PP-T-CBSM，n=75对T-HI，n=75)为组间因素，以时间(干预前、5个月和9个月随访)为组内因素，比较被分配到PP-T-CBSM的参与者和注意时间匹配的电话健康信息(T-HI)控制条件下的CFS症状、神经免疫指标和心理社会(患者和伴侣)功能的变化。 公共卫生相关性：由于慢性疲劳综合征(CFS)是一种无法治愈的衰弱疾病，而且由于残疾和重复使用医疗资源而导致的高失业率对社会构成经济负担，因此干预措施必须针对长期管理，解决维持这种疾病症状的多层面因素。这项研究的结果具有重大意义，因为它们可能提供一种干预措施，通过基于理论的综合压力管理方法有效地管理CFS症状，并将覆盖到更广泛的CFS患者群体，否则他们将无法从这些经验支持的技术中受益。这项拟议的研究具有创新性，是第一个测试患者-伴侣视频电话传递的心理社会干预(PP-T-CBSM)对CFS患者的影响的随机试验，同时检测神经免疫机制(下丘脑-垂体-肾上腺[HPA]轴细胞因子调节)，以解释这种干预对CFS症状的影响。

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.