Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in average pain according to the Brief Pain Inventory
研究概览
简要总结
The investigators are studying whether a brief three-session mind-body workshop helps people with fibromyalgia. The investigators hypothesize that this workshop will significantly improve pain and other symptoms, compared to usual care.
详细描述
The affective self-awareness approach presumes that many chronic pain states, such as fibromyalgia (FM), can be effectively treated by encouraging self-awareness of emotional tension. While anecdotally effective in selected patients, this approach has thus far not been tested in a randomized controlled trial. Our purpose is to determine whether an affective self-awareness approach significantly improves pain, tenderness, and other FM symptoms in a random sample of FM patients; and to determine what psychosocial factors predict a favorable response.
Comparisons: changes in ratings of pain, tenderness, and other symptoms between two arms of the study:
- three weekly 2-hour small-group meetings supplemented with daily writing and meditative exercises to enhance affective self-awareness
- usual care
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fibromyalgia, as defined by American College of Rheumatology 1990 criteria.
- •at least 18 years of age.
- •have access to transportation to and from Providence Hospital, Southfield, MI.
排除标准
- •co-morbid medical conditions capable of causing a worsening of physical functional status independent of FM, including morbid obesity, autoimmune diseases, cardiopulmonary disorders (e.g. angina, congestive heart failure, COPD, chronic asthma), uncontrolled endocrine or allergic disorders (e.g. thyroid dysfunction, Type I diabetes), pregnancy, and malignancy within the preceding 2 years.
- •any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), post-traumatic stress disorder, current suicide risk or history of suicide attempt, or substance abuse within 2 years. Note: Subjects with mood or anxiety disorders otherwise will not be excluded.
- •changes in medication regimen within one month prior to enrollment.
研究组 & 干预措施
Workshop
Affective Self Awareness intervention
干预措施: Affective Self-Awareness workshop (Behavioral)
Control
Waiting-list control.
结局指标
主要结局
Change in average pain according to the Brief Pain Inventory
时间窗: 6 months
次要结局
- Change in Multi-dimensional Fatigue Inventory(6 months)
- Medical Outcomes Study sleep subscale(6 months)
- Perceived Stress Scale(6 months)
- SF-36 Physical Functional Status(6 months)
- Profile of Mood States(6 months)
- Tender point count(6 months)
- Dolorimeter tender point score(6 months)
- Ascending and Multiple Random Staircase thumbnail sensitivity thresholds(6 months)
研究者
Mike Hsu
Research Fellow, Clinical Lecturer
University of Michigan