Pilot Study of CBT and Self-hypnosis Training for Pain in Persons With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- A composite of average daily pain intensity measured using a 0-10 NRS via four phone interviews performed on different days by research staff.
研究概览
简要总结
The purpose of this study is to see if treatments that include components of self-hypnosis training and cognitive behavioral therapy (CBT) can help decrease pain in people with MS.
详细描述
This study examined the benefits of two treatments, individually and together, for helping individuals with MS manage their pain. We conducted a time series design in which MS subjects received all four treatment conditions in two orders (randomly assigned): (1) Control (education intervention-CONT),Self-Hypnosis Training (HYP), Cognitive Behavioral Therapy (CBT), HYP-CBT(a combination of HYP and CBT) and (2) CONT, CBT, HYP, HYP-CBT. Subjects attended 16 60-minute treatment sessions conducted by one of the study's psychologists either at the UW,HMC or in the subject's home. Each subject received four treatment sessions of each treatment module listed above. Primary outcome measures were collected via the telephone and mail by research personnel blind to the treatment condition before treatment, immediately after treatment ends and one month after treatment ends. Secondary outcome measures were collected at the same assessment points via pencil and paper interviews completed by subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Chronic ongoing pain (i.e., pain at all times) with an average pain intensity of at least 4/10 on 0-10 numeric rating scale
- •Pain is either worse or started since the onset of other MS symptoms.
- •Pain of at least six months duration.
- •Reads, speaks and understands English.
- •Definitive diagnosis of multiple sclerosis (MS)
- •At least 18 years of age
- •Recruited from a recruitment source approved by the IRB
排除标准
- •Severe cognitive impairment resulting in the inability to verbally comprehend, learn, and recall new auditory verbal information, as reflected by a TICS score of 20 or less.
- •Currently participating in counseling and/or psychotherapy more than once a week.
- •Currently taking anti-psychotic medications
- •Has been hospitalized for psychiatric reasons in the past six months
- •Experiencing current active suicidal ideation.
- •Has received treatment or participated in a clinical trial that involved significant elements of either CBT or hypnosis within the past year.
结局指标
主要结局
A composite of average daily pain intensity measured using a 0-10 NRS via four phone interviews performed on different days by research staff.
时间窗: Before treatment, after each treatment module, and 1-month after the final treatment module.
次要结局
- Sleep quality- Medical Outcomes Sleep Study Measure (Hays et al., 2005)(before treatment, after each treatment module, one month after 4th treatment modules)
- Depression- (CMDI; Nyenhuis et al., 1998)(before treatment, after each treatment module, one month after 4th treatment modules)
- Catastrophizing cognitions- (PCS; Sullivan et al. 1995)(before treatment, after each treatment module, one month after 4th treatment modules)
- Adaptive cognitions (CPAQ; McCracken et al., 2004)(before treatment, after each treatment module, one month after 4th treatment modules)
- Distinguishing neuropathic vs. non-neuropathic pain (S-LANSS; Bennett et al., 2005)(before treatment, after each treatment module, one month after 4th treatment modules)
- Pain Interference-(Brief Pain Inventory, Cleeland et al., 1994)(before treatment, after each treatment module, one month after 4th treatment modules)
- Impact of Fatigue (FIS; Fisk et al. 1993)(before treatment, after each treatment module, one month after 4th treatment modules)
- Fatigue Severity (FSS; Krupp et al., 1989)(before treatment, after each treatment module, one month after 4th treatment modules)
- Health Status (SF-36; Ware et al., 1992)(before treatment, after each treatment module, one month after 4th treatment modules)
研究者
Mark Jensen
Principal Investigator
University of Washington