Non-drug Interventions for Migraines

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This proposal describes a randomized controlled pilot trial investigating feasibility, safety, and migraine frequency in patients with migraines who undergo an 8 week mindfulness based stress reduction (MBSR) program compared to a wait-list control group.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mindfulness and Mechanisms of Pain Processing in Adults With Migraines

NCT02695498

Migraine

COMPLETED NA

Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine

NCT00826475

Migraine

COMPLETED NA

Mindfulness and Migraine Research Study

NCT02824250

Migraine Chronic Pain

COMPLETED NA

Mind Body Intervention for Chronic Migraine Headaches

NCT06690060

Migraines Chronic Pain

RECRUITING NA

Chronic Migraines and Neurofdeeback Mindfulness

NCT06342219

Chronic Migraine, Headache

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Preliminary research has shown MBSR to be effective in chronic pain syndromes and other mind/body interventions have shown good promise in the treatment of headaches. A randomized controlled trial (RCT) of yoga in migraine without aura patients by John and colleagues showed that yoga resulted in a significant decrease in headache frequency, pain index, and symptomatic medication usage compared to a self-care group. This RCT demonstrated that patients with headaches may benefit from a mind-body intervention. However, their yoga protocol was not specified, and participants were instructed to practice the technique only during the prodromal phase of a headache (prior to the pain becoming severe), so as an abortive intervention at the time of a headache. Thus, the investigators of this trial are proposing to evaluate the effect of MBSR on adults with migraines compared to an education control group. This study will add to the John study because, unlike many other mind-body interventions, MBSR offers the distinct advantage of a standardized protocol that has been used both clinically and in numerous research studies across a wide variety of conditions. Furthermore, MBSR teaches participants a daily practice that, if effective, could serve as a prophylactic intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine Headache

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mindfulness Based Stress Reduction

Participants will complete an 8 week course in Mindfulness Based Stress Reduction (MBSR), meeting once/week for 8 weeks and having a 4-6 hour retreat after the 6th class

Group Type EXPERIMENTAL

Mindfulness Based Stress Reduction (MBSR)

Intervention Type BEHAVIORAL

MBSR involves 8 weekly 2 hour classes and one 4-6 hour retreat after the 6th class

Wait-List Control Group

These participants will continue in usual care during the trial and will be offered the intervention of MBSR after the trial is over.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindfulness Based Stress Reduction (MBSR)

MBSR involves 8 weekly 2 hour classes and one 4-6 hour retreat after the 6th class

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of migraine (International Classification of Headache Disorders-II);21
* 4-14 days with migraines/month
* ≥one year of migraines
* ≥18 years
* Able and willing to attend weekly sessions and willing to participate in daily mindfulness assignments, up to 30-45 min/day
* Agreeable to participate and to be randomized to either group
* Fluent in English (since the treatment groups will be run in English)
* Good general health with no additional diseases expected to interfere with the study

Exclusion Criteria

* Current regular meditation/yoga practice
* Any major systemic illness or unstable medical or psychiatric condition (e.g. suicide risk) requiring immediate treatment or that could lead to difficulty complying with the protocol
* Diagnosis of medication overuse headache (International Classification of Headache Disorders-II);19
* Current or planned pregnancy or breastfeeding
* New prophylactic migraine medicine started within 4 weeks of the screening visit
* Unwilling to maintain stable current doses of migraine medicines for the duration of trial
* Failure to complete baseline diary recordings of migraine activity and medication use

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes