Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory
研究概览
简要总结
The proposed project will evaluate the efficacy of a telephone-delivered self-management (T-SM) intervention for reducing the impact of secondary conditions in persons with multiple sclerosis (MS), including chronic pain, fatigue, depression, and cognitive impairment. It is hypothesized that if the effects of these conditions are reduced, study participants will demonstrate improved participation in the community and improved employment outcomes. This project is important because the majority of persons with MS experience one or more of the following secondary conditions: fatigue, pain, depression, and cognitive impairment. These secondary conditions are not always readily apparent and constitute what has been described by our Rehabilitation Research and Training Center as "hidden disabilities." Secondary conditions such as pain, depression, fatigue, and cognitive impairment frequently not only cause distress in their own right but also affect employment, participation, and quality of life. Having more than one often compounds the effect; the effect of all may be greater than the sum of each individually (e.g. depression can worsen fatigue, and cognitive impairment can worsen depression).
It is critical that this constellation of secondary symptoms be addressed using state of the art techniques based on self-management training and that intervention effects be documented with carefully controlled treatment efficacy studies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be diagnosed with MS by a physician.
- •Must be at least 18 years of age.
- •Must be able to understand, speak, and read English.
- •Must have the presence of at least one of four common secondary conditions (fatigue, pain, depression, cognitive difficulties) that interferes with employment, participation, and functioning.
排除标准
- •Unable to understand or read English.
- •Severe cognitive impairment, defined as one or more errors on the 6-item screener, that would prevent informed consent and inability to carry on a phone conversation.
- •Currently participating in regularly scheduled psychotherapy.
- •Psychiatric contraindications such as current psychosis, active suicidal ideation, or current alcohol or drug use.
结局指标
主要结局
Brief Pain Inventory
时间窗: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
PHQ 9
时间窗: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
Modified Fatigue Impact Scale
时间窗: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
次要结局
- PROMIS Fatigue Short Form(Baseline, 5 weeks, 10 weeks, 6 months, 12 months)
- PROMIS Depression Short Form(Baseline, 5 weeks, 10 weeks, 6 months, 12 months)
- PROMIS Pain Impact Short Form(Baseline, 5 weeks, 10 weeks, 6 months, 12 months)
研究者
Dawn Ehde
Professor, Rehabilitation Medicine
University of Washington