Enhancing the Benefits of Pain and Fatigue Treatment in MS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in average pain intensity pre-treatment to post-treatment
研究概览
简要总结
People with Multiple Sclerosis (MS) often have pain and/or fatigue. Unfortunately, available treatments provide inadequate relief for the majority of these individuals. There remains an urgent need for additional treatment options for MS-related symptoms. The purpose of this study is to see if alternative treatments that involve self-hypnosis training, neurofeedback training and/or mindfulness meditation training, or a combination of some of these treatments can help decrease pain and fatigue in people with MS. A subject must have a diagnosis of MS, have chronic pain and/or fatigue, and be at least 18 years old to participate, among other criteria.
详细描述
Individuals from the study's recruitment sources with an MS diagnosis will be contacted by research staff via telephone and invited to be screened for participation. In addition, individuals interested in participating may contact research staff upon learning about the study through a description listed on an approved website, flyer, or a referral. Research staff will use a recruitment script for purposes of screening subjects and explaining the study. In addition, the initial screening process will also include a 6-item cognitive screening and a psychological screening assessment done by a licensed clinician.
Research staff will verify the MS diagnosis of prospective subjects who have not been 'pre-verified' in one of three ways during the recruitment process:
- Research staff will attempt to determine whether a subject has a University of Washington Medical Center (UWMC) or Harborview Medical Center (HMC) medical record by conducting a simple search using a secure application.
If research staff are unable to locate a medical record for the prospective subject, or if the individual contacts research staff after seeing the study description on an approved website or flyer, then one of two options will be pursued: 2. Subjects will be asked during the initial screening process if staff may review their medical records if they have received services at the UWMC/HMC since their diagnosis; 3. Subjects will be asked during the initial screening process if staff may contact a physician of their choice to verify their diagnosis if (a) they have not received services at the UWMC/HMC since their diagnosis; (b) they refuse to give staff permission to review their UWMC/HMC medical records; or (c) staff for some reason cannot find a UWMC/HMC medical record despite the subject attesting to being a patient at one time at the UWMC/HMC and giving staff permission to review his/her records.
Only individuals whose diagnosis has been verified (either via medical record review prior to/during screening or through verification via the subject's physician depending on recruitment source) will proceed with the psychological screening assessment.
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
- •18 years of age or older
- •Diagnosis of MS
- •Moderate to severe chronic pain and/or fatigue
- •Able to read, speak, and understand English
排除标准
- •Severe cognitive impairment defined as two or more errors on the Six-Item Screener
- •History of seizure activity
- •Psychiatric condition or symptoms that would interfere with participation
- •Currently receiving psychological treatment for pain and/or fatigue
- •Has participated in any previous or current research study conducted by investigators in the Department of Rehabilitation Medicine that involved pain or fatigue management via psychological treatments
研究组 & 干预措施
Intervention #1
NF-HYP
干预措施: Intervention #1 (Behavioral)
Intervention #2
MM-HYP
干预措施: Intervention #2 (Behavioral)
Intervention #3
HYP-ONLY
干预措施: Intervention #3 (Behavioral)
结局指标
主要结局
Change in average pain intensity pre-treatment to post-treatment
时间窗: Pre-treatment (1 week before Session 1), Mid-treatment (1 week before Session 7), Post-treatment (within a week after Session 11), 1-month following end of treatment
Average pain intensity will be assessed via telephone interviews using a 0-10 numerical rating scale (NRS) of average pain in the past 24 hours, four times within a 1-week period at each assessment point.
Change in average fatigue severity pre-treatment to post-treatment
时间窗: Pre-treatment (1 week before Session 1), Mid-treatment (1 week before Session 7), Post-treatment (within a week after Session 11), 1-month following end of treatment
Fatigue severity will be assessed with the Fatigue Severity Scale (FSS). The 9-item FSS asks respondents to rate fatigue and the extent to which it interferes with activities on 1 (Strongly disagree) to 7 (Strongly agree) scales. The FSS is assessed once at each assessment point.
次要结局
未报告次要终点
研究者
Mark Jensen
Professor
University of Washington