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Migraine | One-Day Intervention for Depression and Impairment in Migraine Patients

Migraine research study

What is the primary objective of this study?

The purpose of this research study is to examine whether a one-day group workshop, integrating principles from Acceptance and Commitment Therapy and Migraine Education, will result in greater improvements in depressive symptoms and functioning impairment in patients with comorbid migraine and depression than a similar one-day group workshop with Migraine Education only.

Who is eligible to participate?

Inclusion Criteria: - Ages 18-65 - Current major depressive episode on the SCID-IV (46) - Score of ≥ 17 on the HRSD (47) - Confirmation of diagnosis of migraine from medical record - 4-12 migraines in the previous month Exclusion Criteria: - Bipolar, psychotic, or current substance use disorders - History of brain injury - Imminent suicidality.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Migraine

Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:ACT-ME1 hour discussion about migraine education (ME) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). Migraine education covers topics including migraine symptoms, triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations.

Behavioral:Migraine Education Only6 hour discussion of migraine education only (MEO). This will involve educating participants about migraine, its natural course, its prodromal symptoms and triggers for symptom worsening, risk for migraine chronification, how to use abortive migraine medications, medication overuse headache, medical and psychological treatments of migraine, migraine comorbidity, and menstrual migraine.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ACT-MEACT-ME is designed to reduce behavioral avoidance and to enhance acceptance-based coping. It includes: 1) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 2) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations; and 3) Migraine education whereby each of the educational topics listed below will be covered without detailed discussion of the topics.

Migraine Education OnlyThe MEO workshop will last six hours and involve educating participants about migraine, its natural course, its prodromal symptoms and triggers for symptom worsening, risk for migraine chronification, how to use abortive migraine medications, medication overuse headache, medical and psychological treatments of migraine, migraine comorbidity, and menstrual migraine. The group leaders will present one educational topic at a time and the participants will discuss and reflect about issues and experiences related to the topic. If necessary, the group leaders will raise specific discussion questions to facilitate group dialogue and participant involvement. However, information on coping practices will be omitted.

Study Status

Completed

Start Date: September 2013

Completed Date: September 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: HRSD

Secondary Outcome: WHO-DAS-II

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Baylor College of Medicine

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02108678

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