Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quality of Life (MS-QOL-54)
研究概览
简要总结
This single-center interventional study quasi-randomly allocated patients to a guided imagery or control intervention (positive journaling). Data were analyzed with treatment allocation masked.
详细描述
Interventions: Participants were assigned in alternate order to 10 weekly 1-hour sessions "Healing Light Guided Imagery" or at-home positive journaling; drop-outs were replaced.
Intervention Type: Behavioral
Multiple sclerosis (MS) is an autoimmune disease that affects the brain and spinal cord (central nervous system). Because nerves in any part of the brain or spinal cord may be damaged, patients with multiple sclerosis can have symptoms in different parts of the body. Many Multiple Sclerosis patients suffer from depression, fatigue and anxiety in addition to physical symptoms. Drugs prescribed for MS have been shown to not improve these comorbid psychological symptoms. Researchers have shown that mindfulness-based training programs can help MS patients, but these therapies are highly resource demanding and taxing for those involved. "Healing Light" Guided Imagery (HLGI; supplementary materials) is a guided imagery therapy that simulates a self-hypnotic trance state that has been anecdotally shown to improve depression and fatigue in patients with MS in less time and with fewer support resources. The investigators plan to test whether HLGI can increase patient well-being.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Relapsing-Remitting Multiple Sclerosis
- •18-70 years old
- •Able to read and write in English
- •Able to attend sessions at the UC San Diego School of Medicine
- •Age group: adult
- •Gender: both
- •Target enrollment: 20
- •Participant exclusion criteria:
- •Severe depression (score of 31 or higher on the BDI)
- •Very high levels of fatigue (above an average of 6 on the FSS)
- •Low levels of mindfulness (below an average score of 2 on the FMI).
排除标准
- 未提供
结局指标
主要结局
Quality of Life (MS-QOL-54)
时间窗: Change from baseline at 10 weeks
Quality of Life based on Multiple Sclerosis Quality of Life Instrument (MS-QOL-54)
次要结局
- Mood (BDI-II)(Change from baseline at 10 weeks)
- Fatigue (FSS)(Change from baseline at 10 weeks)
研究者
Paul J. Mills
Professor
University of California, San Diego