Image

Treatment for Migraine and Mood RCT

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (Telephone), video (Video) or online education modules (Online).

Description

This study aims to set the stage for a future definitive large-scale Phase III trial in patients with migraine and depressive symptoms. This pilot is aimed evaluating the feasibility and acceptability of the Telephone and Video MBCT and Online education modules in people with migraine (defined by the International Classification of Headache Disorders - 3) and depressive symptoms (defined by empirical cut-offs on the Patient Health Questionnaire - 9).

Eligibility

Inclusion Criteria:

  • Currently meets ICHD-3 (International Classification for Headache Disorders - 3rd Edition) criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module
  • Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
  • Score between 5-14 on the PHQ-9 (Patient Health Questionnaire)
  • Age ≥ 18
  • Ability to read and speak English
  • Capacity to consent
  • Prospective diary-confirmed 4-14 headache days per month, with at least one attack meeting migraine criteria
  • ≥1 year of migraine

Exclusion Criteria:

  • Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the American Migraine Prevalence and Prevention Diagnostic Module
  • Changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake
  • Changes in longer-term migraine prevention (onabotulinum toxin A, injectable or oral anti-calcitonin gene related peptide treatment; neuromodulatory device) within 3 months of intake
  • Changes in acute migraine treatment started within 4 weeks of enrollment
  • Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the intervention, including but not limited to: active suicidal ideation; recent history of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities; bipolar disorder; obsessive-compulsive disorder, drug use
  • Prior history of engaging in formal mindfulness-based interventions including: MBSR (Mindfulness-based stress reduction), MBCT (Mindfulness-based cognitive therapy), Acceptance and Commitment therapy, Dialectical Behavior Therapy
  • Current daily meditation practice
  • Inability to adhere to headache diary during baseline evaluation period (recorded fewer than 25/28 days)
  • Unwilling to maintain stable current acute or preventive medication dosages for study duration
  • Any condition that would prevent being a suitable candidate or interfere with medical care needs
  • Inability to adhere to headache diary during baseline evaluation period (recorded fewer than 25/28 days).

Study details

Migraine, Depressive Symptoms

NCT05576467

Albert Einstein College of Medicine

15 June 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.