ACT for High Frequency Migraine; A Virtual Mindfulness Intervention

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-25

Study Completion Date

2021-11-23

Brief Summary

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Mindfulness Training specifically for pain to be offered to migraine patients

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Detailed Description

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Patients with high frequency migraine will be randomized to UC or intervention. Those in intervention will attend a multi session training on Acceptance and Commitment Therapy. All participants will track responses.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

After screening, patients will be randomized and one group will receive the intervention. The investigators will do sequential interventions of the ACT

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

randomized control

Study Groups

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usual care

Subjects randomized to the usual care control group will continue using their usual medical care as prescribed by their physician.

Group Type NO_INTERVENTION

No interventions assigned to this group

ACT

An 8-week mindfulness-based group therapy.

Group Type ACTIVE_COMPARATOR

ACT

Intervention Type BEHAVIORAL

mindfulness intervention for patients with pain/migraine

Interventions

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ACT

mindfulness intervention for patients with pain/migraine

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women ages 18-65
* Diagnosis of episodic migraine (according to International Classification for Headache Diagnosis criteria)
* 4-14 migraine days per month over the past 3 months
* No change in medication in the past 3 months
* Greater than 1 year of migraines
* Agreeable to participate, commit to all study procedures and to be randomized to either group
* Fluent in English

Exclusion Criteria

* Any unstable medical or psychiatric conditions requiring immediate treatment or could lead to difficulty complying with the protocol
* Active suicidal ideation
* Moderate to severe depression
* Current alcohol or substance abuse
* Recent Cognitive Behavioral Therapy, Mindfulness Based Cognitive Therapy, Dialectic Behavioral Therapy or Acceptance and Commitment Therapy within past 3 years
* Current use of narcotics
* Psychiatric hospitalization within past year
* Comorbid pain condition rated as more painful than migraine
* Starts new migraine treatment during study
* Inability to complete study visits

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No