Brain Education and Wellness Program for Migraine
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: Unstable medical condition, Medication overuse, Heavy alcohol, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this randomized clinical trial is to evaluate two different non-drug, virtual treatment options designed to improve the lives of patients with migraine. Both interventions involve 8 weekly sessions and an online platform with additional content and learning. Participants can stay on all their medications during this study. Information from this study may help determine how to better treat migraine.
Will I have to stop taking my current medications?
No, you can stay on all your current medications during this study. However, you need to maintain stable dosages throughout the study.
What data supports the effectiveness of the Brain Education and Wellness Program for Migraine treatment?
Research suggests that mindfulness-based stress reduction (MBSR), a key component of the program, may help reduce depressive symptoms in migraine patients and has shown promise in small studies for migraine therapy, although more research is needed to confirm its effectiveness.
12345Is the Brain Education and Wellness Program for Migraine safe for humans?
Mindfulness-based stress reduction (MBSR), a component of the Brain Education and Wellness Program, is generally considered safe for humans and has no known side effects. It has been used effectively for several chronic pain conditions, including migraines, without reported safety concerns.
12345How does the Brain Education and Wellness Program for Migraine differ from other migraine treatments?
The Brain Education and Wellness Program for Migraine, which includes Mindfulness-Based Stress Reduction (MBSR), is unique because it is a non-drug treatment that focuses on meditation and stress reduction, offering an inexpensive option without side effects. Unlike medications, it addresses both pain and psychological well-being, improving sleep quality and potentially reducing headache frequency.
12367Eligibility Criteria
This trial is for adults with migraines occurring 4-20 days a month, who've had migraines for at least a year. Participants must be fluent in English, able to attend 8 weekly online classes, and willing to keep headache logs. Pregnant women up to 16 weeks can join. Those with heavy alcohol/drug use, other clinical trial participation, meditation experience or unstable medical conditions are excluded.Inclusion Criteria
Fluent in English
I have migraines, with headaches occurring 4-20 days a month.
Completion of technology onboarding with the online platform
+6 more
Exclusion Criteria
Major unstable medical/psychiatric condition that could be unsafe for participants or for the group environment
Participation in another intervention clinical trial or one that would interfere in this study
I have headaches from overusing my migraine medication.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
1 visit (virtual)
Treatment
Participants engage in 8 weekly virtual sessions plus use of an online platform
8 weeks
8 visits (virtual)
Follow-up
Participants are monitored for changes in migraine-related outcomes post-intervention
12 weeks
All assessments and surveys completed virtually
Long-term Follow-up
Participants' migraine disability is assessed at 20 and 32 weeks post-intervention
24 weeks
Assessments at 20 and 32 weeks (virtual)
Participant Groups
The study compares two non-drug virtual treatments aimed at improving life quality for migraine sufferers through an online platform over eight sessions. The effectiveness of these interventions will be evaluated while participants continue their usual migraine medications.
2Treatment groups
Experimental Treatment
Group I: Brain Education and WELLness with Migraine Group BExperimental Treatment1 Intervention
8 weekly virtual sessions plus online platform
Group II: Brain Education and WELLness with Migraine Group AExperimental Treatment1 Intervention
8 weekly virtual sessions plus online platform
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest University Health SciencesWinston-Salem, NC
Cambridge Health Alliance - Center for Mindfulness and CompassionCambridge, MA
Cincinnati Children's Hospital Medical CenterCincinnati, OH
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
National Center for Complementary and Integrative Health (NCCIH)Collaborator
References
Meditation for migraines: a pilot randomized controlled trial. [2022]Our objective was to assess the safety, feasibility, and effects of the standardized 8-week mindfulness-based stress reduction (MBSR) course in adults with migraines.
Conducting a pilot randomized controlled trial of community-based mindfulness-based stress reduction versus usual care for moderate-to-severe migraine: protocol for the Mindfulness and Migraine Study (M&M). [2020]Migraine is one of the most common neurological disorders in clinical practice and is a substantial cause of disability worldwide. Current approaches to therapy are primarily based on medication but are often limited by inadequate effectiveness and common side effects. Newer, more effective medications are expensive. Mindfulness-based stress reduction (MBSR), an 8-week classroom-based meditation intervention, is inexpensive, has no known side effects, and has demonstrated clinically meaningful effectiveness for several chronic-pain syndromes. In addition, MBSR has shown promising results for migraine therapy in a few small case studies and pilot studies. We present here the protocol for a two-arm randomized controlled pilot trial of MBSR for moderate-to-severe episodic migraine, which, if successful, will form the basis for a fully powered clinical trial.
Effectiveness of Mindfulness Meditation vs Headache Education for Adults With Migraine: A Randomized Clinical Trial. [2022]Migraine is the second leading cause of disability worldwide. Most patients with migraine discontinue medications due to inefficacy or adverse effects. Mindfulness-based stress reduction (MBSR) may provide benefit.
Effects of mindfulness-based stress reduction on perceived stress and psychological health in patients with tension headache. [2022]Programs for improving health status of patients with illness related to pain, such as headache, are often still in their infancy. Mindfulness-based stress reduction (MBSR) is a new psychotherapy that appears to be effective in treating chronic pain and stress. This study evaluated efficacy of MBSR in treatment of perceived stress and mental health of client who has tension headache.
Effectiveness of mindfulness-based stress reduction as a non-drug preventive intervention in patients with migraine - a systematic review with meta-analyses. [2023]Introduction Migraine is a neurological disorder characterized by recurrent, severe headaches that are often accompanied by other symptoms. There are various factors that can be trigger a migraine in sufferers. Stress can be such a trigger. Drug and non-drug treatments are available for the preventive treatment of migraine. According to a german guideline, mindfulness can be recommended for the prophylaxis of migraine. Therefore, the aim was to investigate the effectiveness of MBSR in relation to patient-relevant outcomes in adult patients with migraine. Patient-relevant outcomes in this context are migraine frequency, headache intensity during a migraine attack, depressive symptoms and quality of life. Material and Methods The conduct of this study was guided by the PRISMA 2020 statement. A systematic literature search for randomized controlled trials of the effectiveness of MBSR in adult migraine patients was conducted in December 2021 in three databases: MEDLINE via PubMed, the Cochrane Library, and Web of Science. In addition, a review of reference lists and a search of study registries were performed. Last search was conducted on October 7, 2022. In a two-step process, studies were selected based on predefined inclusion and exclusion criteria. The potential for bias was assessed using the Cochrane Risk of Bias Tool 2. The results were summarized descriptively and by means of quantitative synthesis. Results Four RCTs with a total of 275 patients and the follow-up publication of one of these studies were included. The risk of bias in one study each was judged to be low or of some concern, and high in two studies. Four studies were included in the quantitative analysis. For the endpoint migraine frequency, the meta-analytic summary of three studies failed to show a statistically significant benefit for MBSR (SMD -0.23; 95% CI -0.79 to 0.32). For the endpoint depressive symptoms, a meta-analytic summary of three studies showed a statistically significant benefit for MBSR (SMD -0.59; 95% CI -0.93 to -0.25). No study had examined the severity of headaches during a migraine episode. Conclusion Some results suggest that migraine patients may benefit from MBSR. However, the evidence base is currently insufficient for recommendations on the use of MBSR as a non-drug treatment option. Further adequately powered, high-quality RCTs are needed.
Enhanced mindfulness-based stress reduction in episodic migraine-effects on sleep quality, anxiety, stress, and depression: a secondary analysis of a randomized clinical trial. [2023]Patients with migraine suffer from high morbidity related to the repeated headache attacks, characteristic of the disorder, poor sleep, and a high prevalence of comorbid psychosocial disorders. Current pharmacological therapies do not address these aspects of migraine, but nonpharmacological treatments such as mindfulness-based stress reduction (MBSR) have been shown to improve both pain and psychological well-being. In this secondary analysis, we examined the change over time in sleep quality and psychosocial outcomes from the magnetic resonance imaging outcomes for mindfulness meditation clinical trial and assessed how these mediated treatment response (50% reduction in headache frequency postintervention). We also examined the relationship between baseline values and treatment response. The trial (primary outcomes previously reported) included 98 patients with episodic migraine randomized to either enhanced MBSR (MBSR+) or stress management for headache. They completed psychosocial questionnaires and headache diaries at baseline (preintervention), midintervention (10 weeks after baseline), and postintervention (20 weeks after baseline). There was a significant improvement in sleep quality from baseline to postintervention (P = 0.0025) in both groups. There were no significant changes from baseline or between groups in anxiety, depression, and stress. There was also no significant association between baseline scores and treatment response. Mediation analysis showed a significant indirect effect of 6% for sleep: In other words, small improvements in sleep may have contributed to the efficacy of MBSR+.Trial registration: NCT02133209.
Multimodal biofeedback in the treatment of migraine. [2019]The purpose of this study was twofold: (a) to compare the effects of three behavioral strategies for the relief of migraine, and (b) to examine different combinations of the treatments to assess the effectiveness of multimodal biofeedback with this problem. Twenty-four volunteer migraine sufferers not on medication, and with at least weekly occurrence of headaches, participated in the study. Results indicated that (a) subjects who learned temporal cooling, frontalis relaxation, and progressive muscular relaxation exhibited the best success with headache relief; (b) control subjects, who did not show the same psychophysiological changes as experimental subjects, reported no headache relief; and (c) subjects in the group with only relaxation exercises performed similarly to control subjects and reported no headache relief.