Patient-Partner Stress Management Effects on CFS Symptoms and Neuroimmune Process
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Changes in Frequency and Severity of CDC-based CFS Symptoms
研究概览
简要总结
The purpose of this study is to test the effects of a videotelephone-delivered patient-partner dual-focused cognitive behavioral stress management intervention on chronic fatigue syndrome (CFS) symptoms and related psychosocial and neuroimmune processes in patients diagnosed with chronic fatigue syndrome. Study tests the hypothesis that videophone-delivered patient-partner cognitive behavioral stress management (T-PP-CBSM) intervention improves patient CFS symptoms relative to a videophone-delivered patient-partner Health Information (PP-T- HI) condition.
详细描述
The study tests the effects of a 10-week patient-partner focused videophone-delivered cognitive behavioral stress management intervention (T-PP-CBSM) intervention (relaxation, stress awareness, cognitive restructuring, coping skills training, interpersonal skills training) versus a time-attention-matched 10-week patient-partner based videophone-delivered health information (T-PP-HI) (health behavior education on nutrition, sleep and other factors) in men and women with chronic fatigue syndrome (CFS) and their partners. The study evaluates the effects of T-PP-CBSM vs T-PP-HI on patient CFS symptoms, neuroimmune processes--diurnal cortisol regulation and immune regulation (pro-inflammatory:anti-inflammatory cytokine ratio ([IL-1β + IL-6 + TNF-α]:[IL-13 + IL-10])-and psychosocial functioning at 5 months and 9 months after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women diagnosed with chronic fatigue syndrome
排除标准
- •no partner
- •prior psychiatric treatment for serious psychiatric disorder (e.g., psychosis, suicidality)
- •co-morbidity or medical treatment affecting the immune system
- •lack of fluency in English
研究组 & 干预措施
Cognitive Behavioral Stress Management
干预措施: Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM) (Behavioral)
Health Information
干预措施: Patient-Partner Videotelephone-delivered Health Information (PP-T-HI) (Behavioral)
结局指标
主要结局
Changes in Frequency and Severity of CDC-based CFS Symptoms
时间窗: baseline and 5 and 9 month post-intervention follow-up
Changes in the average frequency and average severity ratings of CFS symptoms as assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The outcome measure was calculated as a set of two composite scores: 1) Average Symptom Frequency, reflecting an aggregated average of frequency across all symptoms, and 2) Average Symptom Severity, reflecting an aggregated average of severity across all symptoms. Change scores are expressed and calculated as Follow-Up minus Baseline scores for average symptom frequency and average symptom severity.
Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms
时间窗: baseline and 5 and 9 months post-intervention follow-up
Changes in the composite product of average frequency and severity scores of CDC-based CFS symptoms assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The composite outcome measure was calculated as the product of Average Symptom Frequency and Average Symptom Severity. Change scores are expressed and calculated as Follow-Up minus Baseline scores for the composite product score.
次要结局
- Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.(baseline and 5 and 9 month post-intervention follow-up)
- Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines(Baseline, 5 months, 9 months)
- Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines(Baseline, 5 months, 9 months)
- Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines(baseline and 5 and 9 months post-intervention follow-up)
- Changes in Psychosocial Functioning(baseline and 5 and 9 month post-intervention follow-up)
研究者
Michael H. Antoni
Principle Investigator
University of Miami