Brief Behavioral Interventions for Adults With Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
研究概览
简要总结
People with chronic migraine headaches face many challenges, including high levels of daily pain, disturbances to everyday activities and sleep, and problems with mood such as depression or anxiety. This trial is being completed to study whether changing an individual's behaviors may have an impact as a treatment for migraine headaches.
Eligible participants will be randomized to one of the four arms. This study will be conducted remotely without in-person contact.
Study Hypothesis:
- There is a main effect of attending either the Empowered Relief and Health Education intervention on reductions in migraine-related disability 1 month after completing either intervention
- There is a main effect of Empowered Relief and Health Education interventions on reducing pain-related catastrophizing and migraine symptom severity 1 month after completing either intervention (secondary hypothesis)
- The expected reductions in migraine-related disability, pain catastrophizing, and migraine symptom severity will be maintained at secondary time points (2 months, 3 months, and 6 months after completing either intervention) (secondary hypothesis)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Self-reported neurologist diagnosis of chronic migraine
- •Meets diagnostic criteria for chronic migraine according to the Identify Chronic Migraine (IDCM) self-reported instrument
- •English-speaking
- •Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone or computer) in the home
- •Age 18 years or older
排除标准
- •Currently receiving cognitive-behavioral therapy for pain or migraine
- •Open litigation regarding a medical condition, as assessed in preliminary study screening
- •Inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols
- •Failure to complete at least 7 out of 14 pre-intervention daily diaries
研究组 & 干预措施
Empowered Relief (ER) class and Health Education (HE) class
If randomized to both classes, the HE class will occur first with a week break in between to the ER class.
干预措施: Empowered Relief (Behavioral)
Empowered Relief (ER) class and Health Education (HE) class
If randomized to both classes, the HE class will occur first with a week break in between to the ER class.
干预措施: Health Education (HE) (Behavioral)
Treatment as Usual (TAU)
干预措施: Treatment as Usual (Behavioral)
Empowered Relief (ER) class
Daily Diaries
干预措施: Empowered Relief (Behavioral)
Health Education (HE) class
干预措施: Health Education (HE) (Behavioral)
结局指标
主要结局
Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
时间窗: Baseline, 1 month
The MIDAS is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability.
次要结局
- Change in Pain Catastrophizing Scale (PCS)(Baseline, 6 month)
- Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores(Baseline, 6 months)
- Change Migraine Symptom Severity Scale (MSSS)(Baseline, 6 month)
- Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores(Baseline, 2 months)
- Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores(Baseline, 3 months)
- Change Migraine Symptom Severity Scale (MSSS)(Baseline, 1 month)
- Change Migraine Symptom Severity Scale (MSSS)(Baseline, 2 month)
- Change Migraine Symptom Severity Scale (MSSS)(Baseline, 3 month)
- Change in Pain Catastrophizing Scale (PCS)(Baseline, 1 month)
- Change in Pain Catastrophizing Scale (PCS)(Baseline, 2 month)
- Change in Pain Catastrophizing Scale (PCS)(Baseline, 3 month)
研究者
John Sturgeon
Assistant Professor of Anesthesiology
University of Michigan