Behavioral Intervention for Chronic Migraine
(RLB Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byDr. Yohannes Woldeamanuel, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Other headache disorders, pregnancy, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial organizers for more details.
What data supports the effectiveness of this treatment for chronic migraine?
Research shows that lifestyle modifications, including diet, physical activity, and behavior therapy, can improve health outcomes in various conditions. Behavioral interventions have been effective in managing chronic illnesses, suggesting they might also help with chronic migraines by promoting healthier habits.12345
Is the behavioral intervention for chronic migraine safe for humans?
How is the Lifestyle Behavior Protocol treatment for chronic migraine different from other treatments?
The Lifestyle Behavior Protocol is unique because it focuses on behavioral changes, like relaxation and cognitive strategies, to help patients recognize and manage factors that trigger migraines, rather than relying solely on medication. This approach empowers patients to improve their quality of life by adopting healthier habits and integrating these strategies with other treatments.1011121314
Eligibility Criteria
This trial is for adults who have been experiencing chronic migraines for at least one year. It's not suitable for individuals with other types of headaches, those under 18, or pregnant women.Inclusion Criteria
I am 18 years old or older.
I have had chronic migraines for at least 1 year.
I am 18 years old or older.
See 1 more
Exclusion Criteria
Current pregnancy
I am under 18 years old.
I have been diagnosed with a headache disorder other than migraines.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo a lifestyle behavior protocol to manage chronic migraine
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Lifestyle Behavior Protocol (Behavioral Intervention)
- Sham Behavior Protocol (Behavioral Intervention)
Trial OverviewThe study is testing a lifestyle behavior protocol designed to manage chronic migraines and will compare it against a sham (placebo) protocol. The trial also aims to identify specific biomolecules related to the condition.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Virtual Therapy GroupActive Control1 Intervention
Group II: Attention Placebo GroupPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo ClinicPhoenix, AZ
Stanford UniversityStanford, CA
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
Stanford UniversityLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
Facilitating dietary change: the patient-centered counseling model. [2022]Recent data indicate that the patient-centered counseling model enhances long-term dietary adherence. This model facilitates change by assessing patient needs and subsequently tailoring the intervention to the patient's stage in the process of change, personal goals, and unique challenges. This article describes this model, including its theoretical foundations, a 4-step counseling process, and applications. This behavioral counseling model can help nutrition professionals enhance patient adherence to nutrition care plans and dietary guidelines.
Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. [2007]As many as two-thirds of adults in developed nations are overweight (body mass index (BMI)=25.0-29.9 kg/m2) or obese (BMI>or=30 kg/m2), and many of these individuals suffer from weight-related comorbidities such as hypertension, hyperlipidemia, and type II diabetes. On a more positive note, recent studies have demonstrated that losses as small as 5-10% of initial weight can improve these health complications. For example, the Diabetes Prevention Program demonstrated that a 7% reduction in initial weight, coupled with 150 min/week of physical activity, reduced the risk of developing type II diabetes by 58% compared with placebo. Behavioral treatment consistently induces weight losses in this range. This paper describes the behavioral treatment of obesity, including its short- and long-term results as well as approaches for improving the maintenance of lost weight. The terms "behavioral treatment," "lifestyle modification," and "behavioral weight control" are often used interchangeably, as they are in this paper. Lifestyle modification includes three principal components: diet, physical activity, and behavior therapy. The latter term, as applied to weight control, refers to a set of principles and techniques to help patients adopt new diet and exercise habits that can be sustained long term to promote health.
Health Psychology: the Search for Pathways between Behavior and Health. [2022]This review of the current status of theoretically based behavioral research for chronic illness management makes the following points: (a) Behavioral interventions have demonstrated effectiveness for improving health outcomes using biomedical indicators, (b) current interventions are too costly and time consuming to be used in clinical and community settings, (c) translation of the conceptual models generated from studies of the problem-solving processes underlying self-management and the relationship of these processes to the self system and cultural and institutional contexts suggest new avenues for developing effective and efficient cognitive-behavioral interventions, and (d) it is proposed that integration of the conceptual developments in self-management with new approaches to the design of clinical trials can generate tailored, behavioral interventions that will improve quality of care.
LINDA - a solution-focused low-intensity intervention aimed at improving health behaviors of young females: a cluster-randomized controlled trial. [2021]We aimed to develop and evaluate the effectiveness of an individualized, long-term support lifestyle counseling approach in promoting healthy physical activity, improving dietary and sleeping behaviors, and preventing weight gain in young females. The counseling approach's intensity was designed to be low enough to be implementable in primary health care.
Role of Counseling to Promote Adherence in Healthy Lifestyle Medicine: Strategies to Improve Exercise Adherence and Enhance Physical Activity. [2023]Although healthy lifestyles (HL) offer a number of health benefits, nonadherence to recommended lifestyle changes remains a frequent and difficult obstacle to realizing these benefits. Behavioral counseling can improve adherence to an HL. However, individuals' motivation for change and resistance to altering unhealthy habits must be considered when developing an effective approach to counseling. In the present article, we review psychological, behavioral, and environmental factors that may promote adherence and contribute to nonadherence. We discuss two established models for counseling, motivational interviewing and the transtheoretical model of behavior change, and provide an example of how these approaches can be used to counsel patients to exercise and increase their levels of physical activity.
Collaboration and Negotiation: The Key to Therapeutic Lifestyle Change. [2023]Counseling patients on behavior change is an important skill that traditional medical training does not emphasize. Most practitioners are trained in the expert approach to handle problems, which is useful in the acute care setting. However, in the case of chronic disease, a coach approach is more effective. This approach allows the patient to reflect on his or her own motivators for change as well as obstacles hindering the change. Changing from the expert approach to the coach approach is contingent on the lifestyle medicine practitioner sharing information when the patient is ready to receive it, listening mindfully, asking open-ended questions, treating problems as opportunities to learn and grow, and encouraging patients to take responsibility for their actions. By collaborating with the patient, the practitioner can guide patients to find solutions to the problems they are facing and foster an environment that leads patients to self-discovery, accepting responsibility for their behaviors, and ultimately, achieving goals that result in healthier daily habits. As a framework and a guide, lifestyle medicine practitioners can use a 5-step cycle of collaboration and a ladder of behavior change when working with patients on behavior change.
Development of DASH Mobile: a mHealth lifestyle change intervention for the management of hypertension. [2013]Several landmark studies based on the DASH diet have established the effectiveness of a lifestyle approach to blood pressure control that emphasizes a diet rich in fruits and vegetables with moderate portions of low-fat dairy and lean protein along with increased physical activity and reduced sodium intake. However, this evidence base remains underused due feasibility limitations of implementing these intense in-person interventions and poor engagement with desktop computer based versions. Mobile technologies such as smartphones and wireless sensors have the ability to deliver behavioral interventions in-the-moment and with reduced user burden. DASH Mobile is a new mHealth system being developed to deliver this evidence-based lifestyle intervention to hypertensive patients. The system consists of an Android based "app" that facilitates easy tracking of DASH food portions, integrated Bluetooth blood pressure, weight and pedometer monitoring, goal setting, simple data visualizations and multimedia video clips to train patients in the basic concepts of the lifestyle change plan. At present, the system is undergoing usability testing with a pilot clinical trial planned for Spring 2013.
Dietary adherence in the Dietary Approaches to Stop Hypertension trial. DASH Collaborative Research Group. [2019]Participants in controlled feeding studies must consume all study foods and abstain from all other foods. In outpatient studies in which adherence may be compromised by free-living conditions, promoting, documenting, and monitoring dietary adherence are necessary. In the Dietary Approaches to Stop Hypertension (DASH) trial, a thorough participant screening process, an orientation session, and a run-in feeding period before randomization aided in the selection of participants who would most likely adhere to the demands of the study protocol. Throughout the feeding period, various educational and motivational techniques were used to encourage DASH participants to adhere to the dietary protocol. Both objective and subjective methods documented excellent participant adherence. Daily monitoring of individual adherence was based on meal attendance, body weight measurements, and daily diaries. Urinary sodium, potassium, phosphorus, and urea nitrogen values and an anonymous poststudy survey were used to evaluate adherence at the end of the study. Most DASH participants adhered to the feeding regimen by consuming only study foods and no other foods. When adherence lapsed, participants generally cited the lack of menu variety as a reason. Successful participant adherence to the constraints of an outpatient controlled feeding study is possible with carefully selected participants and a variety of adherence-promoting strategies incorporated into the study protocol.
How to help patients adopt and maintain a healthy lifestyle? A review of behavioral evidence of determinants and means. [2018]A significant part of the population do not follow dietary and exercise recommendations. In Current Care Guidelines, lifestyle counseling is considered as part of good medical care. Lifestyle diseases are, however, not decreasing. Does counseling fail to reach its goal, or is it being provided at all? In the narrative review article based on systematic surveys, we approach the change in lifestyle through both conscious and automatic psychosocial processes. Research evidence indicates that a change in behavior can be supported through both processes. While intervention studies have been so far conducted mainly by influencing conscious processes, evidence of benefits of using automated processes is growing stronger. We present practical measures to support the desire for change and skills and establishments of habits. The same methods may in part be utilized to change professionals in their own behavior so that provision of quick and simple lifestyle counseling becomes a matter actualized in everyday life.
Lay trainers with migraine for a home-based behavioral training: a 6-month follow-up study. [2019]To evaluate the changes at 6-month follow-up after a home-based behavioral training (BT) provided by lay trainers with migraine to small groups of fellow patients.
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.
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.
Short-term effectiveness of an online behavioral training in migraine self-management: a randomized controlled trial. [2014]Behavioral training (BT) is recommended as a supplementary preventive treatment for migraine. Online interventions have been successful in promoting health behavior change, the evidence for online BT in migraine is limited, however. This randomized controlled trial aimed to determine the post-treatment effectiveness of online BT (n = 195) compared to a waitlist control group (WLC; n = 173) on migraine attack frequency (primary outcome), headache self-efficacy and locus of control (secondary outcomes). BT aims to counteract attacks in the prodromal stage through early detection of prodromal features and self-management via physical relaxation and cognitive behavioral regulation, and was offered with minimal e-mail support in eight online lessons. Results showed that 120 (62%) participants completed BT. A decrease of 20-25% in migraine attack frequency was found in both conditions without a between-group difference (ES = 0.02, p = .71). BT participants improved more than WLC participants on migraine related self-efficacy (ES = 0.86, p
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.