Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 4
- 主要终点
- Neurobiological Outcome: Pain Neurocircuitry (fMRI)
研究概览
简要总结
This study design has two components: 1) a cross sectional assessment of brain connectivity and response to pain in healthy controls and demographically matched fibromyalgia patients, and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients randomized to either CBT (Cognitive Behavioral Therapy) or a Disease Education condition.
The investigators will evaluate a group of fibromyalgia patients who will receive CBT treatment once a week for 8 weeks, for a total of 8 treatments. Baseline data from these patients will be compared to results from pain-free controls and a group of education program controls.
Participants will undergo experimental pain assessments as well as brain neuroimaging.
详细描述
Investigators propose to use fMRI (functional Magnetic Resonance Imaging) to study CNS pain processing during the anticipation and experience of acute pain in individuals with FM and healthy controls. Investigators will recruit patients who are diagnosed with FM as well as healthy controls. After the baseline visit, FM participants will be randomly assigned into the CBT or control condition (Education). Overall, FM Participants will attend 8 treatment visits, and 6 assessment visits (two at baseline, one at mid-treatment, two at the end of treatment, and one at 6 months post-treatment). These assessment visits include a total of 3 fMRI sessions (at baseline, mid-treatment, and end of treatment). Healthy Controls will undergo the same baseline procedures as the FM subjects but will not attend any of the treatment or follow up assessment visits. Findings from this research will provide important information about catastrophizing's CNS (Central Nervous System) correlates.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Study personnel collecting, entering, and analyzing data are blind to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Neurobiological Outcome: Pain Neurocircuitry (fMRI)
时间窗: Post-treatment
Bold responses will be assessed with fMRI (3T)
Clinical outcome: Brief Pain Inventory (BPI)
时间窗: Post-treatment, with long-term exploratory outcomes at 6 Months Post-treatment
Pain-related interference and pain severity
次要结局
- Catastrophizing (PCS)(4 weeks (mid-treatment), as well as Post-treatment)
研究者
Robert Edwards
Robert R. Edwards PhD
Brigham and Women's Hospital