NCT01287481已完成2 期
Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 6
- 主要终点
- Brief Pain Inventory
研究概览
简要总结
This interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. The investigators also will test proposed mediators of the intervention, including improved autonomic regulation, and explore which subgroups of patients benefit the most from each approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:
- •1990 ACR criteria including tender points
- •2010 ACR modified clinical criteria that does not include tender points
排除标准
- •Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus
- •Other serious medical conditions that can impair health status independent of FM
- •Current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk
- •Alcohol/drug dependence in past 2 years
- •Cognitive impairment or dementia
- •Currently have pending (or recently received - within 2 years) FM pain related disability or workman's compensation
- •Unable to fluently read or converse in English
- •Planning to move from the area in the next 14 months
- •Judgment of principle investigator as not appropriate for this trial or all intervention arms
结局指标
主要结局
Brief Pain Inventory
时间窗: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
次要结局
- Beliefs in Pain Control Questionnaire(Baseline, post-treatment, and 6 months post-treatment (primary endpoint))
- SF-12(Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment)
- PROMIS Fatigue short form(Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment)
- Heart Rate Variability(Baseline, post-treatment, and 6 months post-treatment (primary endpoint))
- Pain Catastrophizing(Baseline, post-treatment, and 6 months post-treatment (primary endpoint))
- Positive and Negative Affect Schedule(Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment)
- Health Care Utilization Scale(Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment)
- Emotional Expressivity Scale(Baseline, post-treatment, and 6 months post-treatment (primary endpoint))
- Toronto Alexithymia Scale-20(Baseline, post-treatment, and 6 months post-treatment (primary endpoint))
- BBCA - short form(Baseline, post-treatment, and 6 months post-treatment (primary endpoint))
- Pittsburgh Sleep Quality Index(Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment)
- Center for Epidemiological Studies - Depression Scale(Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment)
- Generalized Anxiety Disorder - 7(Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment)
- Ambivalence over Emotional Expression(Baseline, post-treatment, and 6 months post-treatment (primary endpoint))
- Communication Thoughts and Feelings Questionnaire(Baseline, post-treatment, and 6 months post-treatment (primary endpoint))
- Experimental (thumb nail pressure) threshold and tolerance ratings(Baseline, post-treatment, and 6 months post-treatment (primary endpoint))
- Satisfaction with Life Scale(Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment)
- Multiple Ability Self-Report Questionnaire(Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment)
- Patient Global Assessment of Change(Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment)
- Real-time Physical Activity (Actiwatch)(Baseline, post-treatment, and 6 months post-treatment (primary endpoint))
- Levels of Emotional Awareness Scale(Baseline, post-treatment, and 6 months post-treatment (primary endpoint))
- Impact of Events Scale - Revised(Baseline, post-treatment, and 6 months post-treatment (primary endpoint))
- 2010 ACR modified clinical criteria for FM, including widespread pain index(Baseline, post-treatment, and 6 months post-treatment (primary endpoint))
研究者
Mark A. Lumley
Professor
Wayne State University
研究点 (6)
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