Behavioral Interventions for Chronic Migraine
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Disqualifiers: Cognitive impairment, Litigation, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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)
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on behavioral interventions for chronic migraine.
What data supports the effectiveness of the treatment Empowered Relief for chronic migraine?
Research shows that patient education, a key component of Empowered Relief, can improve self-confidence and management of headaches, leading to better outcomes. Education has been linked to reduced headache frequency and increased self-efficacy, which means patients feel more in control of their condition.
12345Is behavioral therapy for migraine safe?
There are safe and well-tolerated behavioral therapies for preventing migraines, such as biofeedback, cognitive behavioral therapy, and relaxation.
24567How is the Empowered Relief treatment for chronic migraine different from other treatments?
Empowered Relief is a behavioral treatment that focuses on educating patients about their condition and teaching them skills to manage it, which is different from traditional drug treatments. It emphasizes patient awareness and lifestyle changes to reduce migraine frequency and severity, often integrating with other therapies for comprehensive care.
89101112Eligibility Criteria
This trial is for individuals with a neurologist's diagnosis of chronic migraine, who meet specific criteria and can communicate in English. They must have internet access for remote participation. People currently in cognitive therapy for pain or involved in medical litigation, or those unable to consent due to cognitive issues are excluded.Inclusion Criteria
Meets diagnostic criteria for chronic migraine according to the Identify Chronic Migraine (IDCM) self-reported instrument
I have been diagnosed with chronic migraine by a neurologist.
English-speaking
+2 more
Exclusion Criteria
Open litigation regarding a medical condition, as assessed in preliminary study screening
I am currently undergoing therapy for pain or migraine.
I am able to understand and agree to the study's requirements.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to one of four arms and receive either Empowered Relief, Health Education, both interventions, or Treatment as Usual. The interventions are conducted remotely.
1 month
Follow-up
Participants are monitored for reductions in migraine-related disability, pain catastrophizing, and migraine symptom severity at 2, 3, and 6 months after completing the intervention.
6 months
Participant Groups
The study examines if behavior changes through 'Empowered Relief' or 'Health Education' interventions reduce migraine-related disability and symptom severity. Participants will be randomly assigned to one of the groups and followed up remotely at various intervals after completing the intervention.
4Treatment groups
Experimental Treatment
Group I: Treatment as Usual (TAU)Experimental Treatment1 Intervention
Group II: Health Education (HE) classExperimental Treatment1 Intervention
Group III: Empowered Relief (ER) class and Health Education (HE) classExperimental Treatment2 Interventions
If randomized to both classes, the HE class will occur first with a week break in between to the ER class.
Group IV: Empowered Relief (ER) classExperimental Treatment1 Intervention
Daily Diaries
Empowered Relief is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Empowered Relief for:
- Chronic pain
- Acute pain
- Pain-related distress
🇪🇺 Approved in European Union as Empowered Relief for:
- Chronic pain
- Acute pain
- Pain-related distress
🇨🇦 Approved in Canada as Empowered Relief for:
- Chronic pain
- Acute pain
- Pain-related distress
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
[Headache: patient education as part of a multidisciplinary treatment. Are there reliable results?]. [2016]Patient education is an important part of successful headache therapy. Patient education can enhance self-efficacy and influence the locus of control. Motivation and adherence to nonpharmacological therapy (aerobic endurance training and relaxation training) as well as pharmacological therapy may be improved by headache-specific patient education. Patients with specific knowledge of their headache disorder and headache treatment may be more self-confident and successful in handling their disease. In moderately affected headache patients, education alone may result in improvement, whereas education as part of a multidisciplinary treatment is superior in severely affected and chronic patients. All components of a multidisciplinary treatment program should be harmonized toward a comprehensive concept. Patients should take an active part in the therapy.
Building a migraine toolkit for patients: successful management of migraine headache. [2009]Management of migraine headache had once been considered as one of the least satisfying conditions to treat. Fortunately, developments in our understanding of the disorder and available treatment options have revolutionized therapy and greatly improved outcomes of affected patients. Two major factors are the development of a treatment "toolkit" for patients and a mutual setting of goals by the patient and clinician. The treatment "toolkit" includes several very important elements, foremost among them is patient education. This critical component provides a logical basis of therapy by helping patients understand the disorder and aiding deployment of the toolkit. This knowledge empowers patients to optimize treatment outcome and minimize the headache-related disability that drives them to seek treatment. Setting of goals for both acute and preventive care, providing behavioral and lifestyle advice, offering appropriate medications for acute attacks and headache prevention, and incorporating strategies for effective use enhance success. Monitoring outcome can focus the management and help more patients attain effective care rapidly. Employing such an approach can turn therapy into a process that proves to be satisfying to both patient and clinician.
Migraine education improves quality of life in a primary care setting. [2021]The objective of this study was to evaluate the effectiveness of the Mercy Migraine Management Program (MMMP), an educational program for physicians and patients. The primary outcome was change in headache days from baseline at 3, 6, and 12 months. Secondary outcomes were changes in migraine-related disability and quality of life, worry about headaches, self-efficacy for managing migraines, emergency room (ER) visits for headache, and satisfaction with headache care.
Making a new-patient headache education session more patient-centered: what participants want to know. [2021]Purpose: To describe the new-patient Education Session provided by the Calgary Headache Assessment and Management Program, analyze patient evaluations, and generate potential patient-centered improvements based on themes in patient feedback.Materials and Methods: Between 2008 and 2012, 1873 new patients attended the Education Session, and 913 evaluations were completed. Session objectives ratings were analyzed. Open-ended questions regarding most- and least-helpful components and suggestions for improvement were examined using thematic analysis.Results: Eighty-seven percent of respondents indicated they would recommend the session to others with headache. Median objectives ratings ranged from 9.0-10.0 out of 10 and were stable over time. Most-helpful themes included medication, types of headache, our program's multi-faceted management approach, medication overuse, triggers, and not feeling alone. Most respondents left the least-useful and suggestions sections blank or commented "nothing" or "not applicable". Least-useful themes included migraine overemphasis, insufficient or excessive medication content, participant over-disclosure, and lack of practical trigger management strategies.Conclusion: Most attendees found the Education Session useful. Those who did not provided valuable input that will allow us to modify the content. Our findings may benefit other headache programs seeking to implement or improve patient education programing. Implications for RehabilitationHeadache is a common and debilitating condition.Education is an important part of headache treatment, and has been associated with decreases in headache frequency, intensity, and disability, as well as increases in self-efficacy.A new-patient Education Session is a practical and inexpensive way to provide evidence-based medical and behavioral headache information.Quantitative and qualitative analysis of patient evaluations can help gauge relevance and direct content changes.
Migraine patients as trainers of their fellow patients in non-pharmacological preventive attack management: short-term effects of a randomized controlled trial. [2010]In conformity with current views on patient empowerment, we designed and evaluated the effects of home-based behavioural training (BT) provided by lay trainers with migraine to small groups of fellow patients. The primary aims of BT were to reduce attack frequency and increase perceived control over and self-confidence in attack prevention. In a randomized controlled trial the BT group (n = 51) was compared with a waitlist-control group (WLC), receiving usual care (n = 57). BT produced a minor (-21%) short-term effect on attack frequency and clinically significant improvement in 35% of the participants. Covariance analysis showed a non-significant trend (P = 0.07) compared with WLC. However, patients' perceived control over migraine attacks and self-confidence in attack prevention increased significantly with large effect sizes. Patients with high baseline attack frequency might benefit more from BT than those with low attack frequency. In conclusion, lay trainers with migraine strengthened fellow patients' perceived control, but did not induce a significant immediate improvement in attack frequency.
Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. [2019]Background In 2008, the International Headache Society published guidelines on the "evaluation and registration of adverse events in clinical drug trials on migraine". They listed seven recommendations for reporting adverse events in randomized controlled trials on migraine. The present study aimed to evaluate adherence to these recommendations, and based on the results, to recommend improvements. Methods We searched the PubMed/MEDLINE database to identify controlled trials on migraine drugs published from 2010 to 2015. For each trial, we noted whether five of the recommended parameters were presented. In addition, we noted whether adverse events were reported in abstracts. Results We identified 73 trials; 51 studied acutely administered drugs and 22 studied prophylactic drugs for migraine. The number of patients with any adverse events were reported in 74% of acute-administration and 86% of prophylactic drug trials. Only 30 (41%) of the 73 studies reported adverse events with data in the abstracts, and 27 (37%) abstracts did not mention adverse events. Conclusion Adverse events, both frequency and symptoms, should be reported to allow a fair judgement of benefit/tolerability ratio when randomized controlled trials in migraine treatment are published. Clinically significant adverse events should be included in the abstract of every randomized controlled trial in migraine treatment.
Behavioral Therapy Preferences in People With Migraine. [2021]There are safe and well-tolerated level A evidence-based behavioral therapies for the prevention of migraine. They are biofeedback, cognitive behavioral therapy, and relaxation. However, the behavioral therapies for the prevention of migraine are underutilized.
Behavioral therapy for chronic migraine. [2021]Chronic migraine is a disabling condition which affects a considerable proportion of patients. Several risk factors and lifestyle habits contribute to the transformation of migraine into a chronic form. Behavioral treatments, including relaxation, biofeedback, and cognitive behavioral therapy reduce the risk of episodic into chronic migraine transformation, thus restraining the headache-related disability. The rationale of behavioral therapies is that a medical problem should be recognized and thoroughly examined by the patient to be successfully managed. Being aware of factors which precipitate or aggravate migraine allows patients to progressively modulate the frequency and duration of their attacks. Similarly, the acquisition of healthy habits improves the quality of life and the subjective well-being of patients and contributes to breaking the vicious cycle that leads to migraine chronification. The highest level of care is achieved when behavioral therapies are integrated with other treatments, including physical and pharmacological interventions.
Message Framing and the Willingness to Pursue Behavioral Therapy: A Study of People With Migraine. [2022]Behavioral treatments for migraine prevention are safe and effective but underutilized in migraine management. Health message framing may be helpful in guiding patients with treatment decision making. The authors assessed associations between message framing and the willingness to seek migraine behavioral treatment among persons with a diagnosis of migraine headache.
Behavioral medicine for migraine. [2018]Behavioral medicine is based on the biopsychosocial theory that biological, psychological, and environmental factors all play significant roles in human functioning. This article reviews empirically supported and efficacious behavioral approaches to the treatment and management of migraine including cognitive behavioral therapy and biobehavioral training (ie, biofeedback, relaxation training, and stress management). These techniques have demonstrated efficacy when learned and practiced correctly and may be used individually or in conjunction with pharmacologic and other interventions. Data are also reviewed regarding patient education, support groups, psychological comorbidities, modifiable risk factors for headache progression, strategies for enhancing adherence and motivation, and strategies for effective medical communication.
Behavioral approaches to the treatment of migraine. [2007]Behavioral interventions such as biofeedback training, relaxation training, and cognitive-behavior stress management therapy have been identified as efficacious treatments for migraine headache. These treatments, and the formats (clinic-based, limited-contact, and home-based) in which they are taught, are described in this article. Information about public health interventions (school, work, Internet, and mass media) is also briefly addressed. Results of studies examining the efficacy of behavioral treatments, how behavioral treatments compare in effectiveness, and how they can be integrated with pharmacotherapy are reviewed for both adult and pediatric populations. Finally, the role of behavioral treatments in migraine treatment guidelines is discussed, and factors that are associated with response to behavioral treatments are reviewed.
Long-term follow-up of home-based behavioral management training provided by migraine patients. [2022]Behavioral migraine approaches are effective in reducing headache attacks. Availability of treatment might be increased by using migraine patients as trainers. Therefore, Mérelle and colleagues developed and evaluated a home-based behavioral management training (BMT) by lay trainers (1). The maintenance of effects at long-term follow-up is studied in the present study.