A Randomized Controlled Trial of Telephone-delivered Cognitive Behavioral-therapy, Modafinil, and Combination Therapy of Both Interventions for Fatigue in Multiple Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 2
- 主要终点
- Change in the Modified Fatigue Impact Scale (MFIS) Score
研究概览
简要总结
This clinical trial will compare the effectiveness of 3 treatments for fatigue in Multiple Sclerosis: 1) a commonly used behavioral treatment strategy (telephone-based cognitive behavioral therapy), 2) a commonly used medication (modafinil), and 3) a combination of both therapies. Each participant will receive one of these 3 treatments for a total of 12 weeks. Hypotheses are that, at 12 weeks, treatment with combination therapy will overall lead to greater reductions in fatigue impact, fatigue severity, and fatigability compared to monotherapy, and that comorbid depression, sleep disturbances, and baseline disability level will be important effect modifiers that influence treatment effect and adherence.
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)
盲法说明
Rater blinded
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
- •Patients with clinically definite Multiple Sclerosis (MS, all MS subtypes);
- •Age 18 years or older;
- •Presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for ≥ 3 months;
- •Average Fatigue Severity Scale (FSS) score greater or equal to 4 at screening.
排除标准
- •Current shift work sleep disorder, or narcolepsy diagnosed with polysomnography and multiple sleep latency test
- •History of MS relapse within the last 30 days prior to screening (participants will be considered eligible after the 30-day window);
- •Current stimulant or wake-promoting agent use (such as amantadine, modafinil, methylphenidate, or amphetamine) within 30 days of screening;
- •Pregnancy or breastfeeding;
- •Reliance on hormonal contraception AND concomitant unwillingness to use alternative non-hormonal means of birth control (spermicide or condoms) during the course of the study;
- •Current suicidal ideation (SI) with intent or plan;
- •Known hypersensitivity to modafinil or armodafinil or its inactive ingredients;
- •History of the following cardiovascular conditions: recent myocardial infarction (last 6 months prior to screening), unstable angina, left ventricular hypertrophy, mitral valve prolapse, NYHA class III or IV congestive heart failure;
- •History of prescription or illicit stimulant abuse (such as cocaine, amphetamine, methamphetamine);
- •Any other medical, neurological, or psychiatric condition that, in the opinion of the investigators, could affect participant safety or eligibility.
研究组 & 干预措施
Cognitive Behavioral Therapy
8 weekly telephone-based sessions and 2 booster sessions
干预措施: Telephone-based Cognitive Behavioral Therapy (Behavioral)
Modafinil
50-400 mg per day (oral)
干预措施: Modafinil (Drug)
Cognitive Behavioral Therapy + Modafinil
Telephone-based cognitive behavioral therapy (8 weekly therapy sessions and 2 booster sessions) + Modafinil 50-400 mg per day (oral)
干预措施: Telephone-based Cognitive Behavioral Therapy (Behavioral)
Cognitive Behavioral Therapy + Modafinil
Telephone-based cognitive behavioral therapy (8 weekly therapy sessions and 2 booster sessions) + Modafinil 50-400 mg per day (oral)
干预措施: Modafinil (Drug)
结局指标
主要结局
Change in the Modified Fatigue Impact Scale (MFIS) Score
时间窗: Baseline-12 weeks
The Modified Fatigue Impact Scale is a 21-item self-report survey. Each item is rated 0-4, Total scores range from 0-84. . Higher scores indicate a greater impact of fatigue on a person's activities. The primary outcome measure will be the mean within-subject difference between baseline and 12-week Modified Fatigue Impact Scale values (delta-MFIS), compared between the 3 treatment groups.
次要结局
- Change in Fatigue Intensity as Assessed by Self-reported Numerical Rating Scale (NRS) Score.(Baseline-12 weeks)
- Change in Fatigue Interference as Assessed by Self-reported Numerical Rating Scale (NRS) Score(Baseline-12 weeks)
- Change in Fatigability as Assessed by the Self-reported Fatigue Intensity Numerical Rating Scale (NRS) Score and Physical Activity Level(Baseline-12 weeks)
研究者
Tiffany J. Braley, MD, MS
Assistant Professor of Neurology
University of Michigan