One-Day Intervention for Depression and Impairment in Migraine Patients
NCT ID: NCT02108678
Last Updated: 2017-12-22
Study Results
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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COMPLETED
NA
104 participants
INTERVENTIONAL
2013-09-30
2017-09-30
Brief Summary
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Detailed Description
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Aim 1: To examine the efficacy of a 1-day ACT-ME intervention compared to MEO for treating depression in patients with comorbid depression and migraine.
Hypothesis 1: At 3- and 6-month follow-up, ACT-ME will be more efficacious than MEO as assessed by: 1) a significantly greater decline on the Hamilton Rating Scale for Depression (HRSD) total score; 2) a significantly higher proportion of participants showing 50% or greater decline on the HRSD; and 3) a significantly higher proportion of participants no longer meeting depression criteria on SCID-IV.
Aim 2: To examine the efficacy of a 1-day ACT-ME intervention compared to MEO on functioning in patients with comorbid depression and migraine.
Hypothesis 2: At 3- and 6-month follow-up, compared to the MEO group, participants in the ACT-ME group will exhibit significantly greater improvement in functioning (measured by World Health Organization Disability Assessment Schedule-Total Score; WHO-DAS) and quality of life (measured by World Health Organization Quality of Life Total; WHO-QOL), and greater decline in headache-related disability (measured by Headache Disability Inventory; HDI).
Aim 3: To determine whether changes in acceptance-based coping and behavioral avoidance will mediate the changes in depressive symptoms and disability.
Hypothesis 3: Increases in acceptance-based coping and reductions in behavioral avoidance will mediate relations between treatment group and 1) decline in depressive symptoms as measured by the HRSD and 2) disability, as measured by the WHO-DAS and HDI. Acceptance and Behavioral Avoidance will be measured using the Acceptance and Action Questionnaire and Chronic Pain Acceptance Questionnaire.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ACT-ME
ACT-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.
ACT-ME
1 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.
Migraine Education Only
The 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.
Migraine Education Only
6 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.
Interventions
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ACT-ME
1 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.
Migraine Education Only
6 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* History of brain injury
* Imminent suicidality.
18 Years
65 Years
ALL
No
Sponsors
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Baylor College of Medicine
OTHER
Responsible Party
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Lilian Dindo
Professor
Locations
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University of Iowa Carver College of Medicine Department of Psychiatry
Iowa City, Iowa, United States
Countries
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References
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Dindo LN, Recober A, Calarge CA, Zimmerman BM, Weinrib A, Marchman JN, Turvey C. One-Day Acceptance and Commitment Therapy Compared to Support for Depressed Migraine Patients: a Randomized Clinical Trial. Neurotherapeutics. 2020 Apr;17(2):743-753. doi: 10.1007/s13311-019-00818-0.
Other Identifiers
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201301712
Identifier Type: -
Identifier Source: org_study_id