Cognitive Behavioral Therapy for Migraine

(Brave-Mind Trial)

Not yet recruiting at 1 trial location
SM
Overseen BySarah McGlone, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether cognitive behavioral therapy specifically designed for migraines can improve the quality of life for veterans with frequent migraines. Participants will either receive this therapy or participate in migraine education sessions, both delivered remotely. The trial aims to determine which approach is more effective in a real-world setting. Individuals diagnosed with migraines by a doctor and experiencing between 4 to 14 headache days each month may be suitable for this study. As an unphased trial, it offers a unique opportunity to contribute to innovative migraine treatment research that could enhance care for veterans.

What prior data suggests that cognitive behavioral therapy for migraine is safe?

Research has shown that Cognitive Behavioral Therapy for Migraine (CBTm) is generally safe for adults. A large review of studies involving over 6,000 adults found that most participants tolerated CBTm well. However, some studies reported a few side effects, including increased migraine pain and frequency for some individuals, as well as breathing issues. Despite these reports, many participants experienced fewer migraine days after treatment. The therapy also significantly reduced headache problems. Overall, while some risks exist, the therapy is mostly considered safe and effective for reducing migraines.12345

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy for Migraine (CBTm) because it offers a new, non-drug approach to managing migraines. Unlike typical migraine treatments that often rely on medications like triptans or NSAIDs, CBTm focuses on changing thought patterns and behaviors to reduce migraine frequency and severity. This therapy is delivered remotely, making it accessible to more people, and it empowers patients to actively manage their condition, potentially leading to long-term benefits without the side effects associated with medications. Additionally, the migraine education intervention (MEintervention) aims to enhance patients' understanding of migraines, which can further aid in managing the condition effectively.

What evidence suggests that this trial's treatments could be effective for migraine?

Research has shown that cognitive behavioral therapy for migraines (CBTm), which participants in this trial may receive, effectively reduces the number of headache days and improves quality of life. For instance, one study found that people using CBT had 11.5 fewer headache days compared to those who only received educational information, who experienced a reduction of 6.8 days. In this trial, some participants will receive the Migraine Education (ME) intervention, which involves educational information. Another study found that 86% of people using CBT had their headache days cut in half after a year. These findings suggest that CBTm can be a powerful tool for managing migraines.12356

Who Is on the Research Team?

JS

Jason Sico, MD

Principal Investigator

VA Connecticut Healthcare System

MB

Margaret Bauer, PhD

Principal Investigator

VA Connecticut Healthcare System

NR

Nicholas Rattray, PhD

Principal Investigator

Richard L. Roudebush VA Medical Center

DR

Daniel Rogers, PhD

Principal Investigator

VA Connecticut Healthcare System

Are You a Good Fit for This Trial?

This trial is for veterans who experience episodic migraines and are seeking ways to improve their quality of life. Participants should be able to take part in therapy or educational sessions. Specific inclusion and exclusion criteria are not detailed.

Inclusion Criteria

Score of at least moderate disability (≥ 10) on the MIDAS
Fluent in English
I have been diagnosed with migraine by a doctor.
See 3 more

Exclusion Criteria

I have used behavioral treatments for migraine or pain in the past year.
I have a diagnosis of Trigeminal Autonomic Cephalalgia.
Has a pending disability or service connection claim related to migraine or headache disorders
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 sessions of either cognitive behavioral therapy for migraine (CBTm) or migraine education (ME) intervention, delivered remotely

12 weeks

Follow-up

Participants are monitored for retention and feasibility of intervention after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavioral Therapy for Migraine (CBTm)
  • Migraine Education (ME) Intervention

Trial Overview

The study compares two approaches: cognitive behavioral therapy designed for migraine (CBTm) versus general migraine education, to see which better improves quality of life among veterans with migraines.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Migraine education intervention (MEintervention)Experimental Treatment1 Intervention
Group II: Cognitive behavioral therapy for migraine (CBTm)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

Citations

Behavioral Interventions for Migraine May Be Effective ...

In adult populations, CBT was associated with reduced migraine and headache frequency (standardized mean difference [SMD], -0.33; 95% CI ...

Behavioral interventions for migraine prevention: A systematic ...

Results suggest that for adults, CBT, relaxation training, and mindfulness-based therapies may each reduce the frequency of migraine/headache ...

Why Try Cognitive Behavioral Therapy For Migraines

A review of the existing research showed that cognitive-behavioral therapy and relaxation techniques lead to a significant reduction in headache ...

Efficacy of Cognitive-Behavioral Therapy for the ...

Primary outcomes were headache days, headache-related disability, emotional distress, and self-efficacy. The baseline was compared to post-treatment, and ...

Cognitive Behavioral Therapy for Migraine Headache - PMC

Previous studies have demonstrated the effectiveness of behavioral therapy for migraine headaches, including CBT, relaxation, and biological feedback, to reduce ...

A Cognitive Behavioral Therapy Pilot Program Delivered ...

Conclusions: The migraine patients in this telemedicine-based CBT pilot showed improved clinical outcomes over the pilot period, including ...