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

描述（由申请人提供）：这是一项为期5年的研究，旨在评估一项为期10周的基于患者-伴侣电话的认知行为压力管理（CBSM）干预对150名诊断为慢性疲劳综合征（CFS）的患者症状的影响。由于许多慢性疲劳综合症患者由于不可预测的衰弱性疲劳期和有限的行动能力而无法在临床环境中参加干预会议，我们创建了一种通过电信系统在参与者家中提供的CBSM干预形式（即基于电话的CBSM， T-CBSM）。T-CBSM的一个独特之处在于，它使用电话召集个人团体到他们的家中，因此它保留了一些以团体为基础的干预的支持性元素。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cdc为基础的CFS症状的减少、促炎细胞因子、白细胞介素-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。促炎细胞因子的较大减少与唾液皮质醇的AM-PM斜率的较大增加和CFS症状的较大减少相关。这支持我们的神经免疫模型解释T-CBSM对CFS症状的影响。我们还进行了亚组分析，比较有伴侣和无伴侣的CFS患者，发现有伴侣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，通过测试一种新设计的伴侣-患者双焦点视频电话传递的CBSM干预（PP-T-CBSM），允许伴侣在小组环境中与患者一起学习压力管理技术，然后一起练习一系列压力管理技术，如放松和认知、行为和人际交往技能训练。我们将在2 X 3随机实验设计中比较被分配到PP-T-CBSM和注意时间匹配的电话健康信息（T-HI）对照条件下的参与者的CFS症状、神经免疫指标和社会心理（患者和伴侣）功能的变化，组间因素（PP-T-CBSM, n=75 vs. T-HI, n=75）和时间（干预前，5个月和9个月随访）为组内因素。

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.