One-Day Intervention for Depression and Impairment in Migraine Patients
ACT
1 other identifier
interventional
104
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 28, 2014
CompletedFirst Posted
Study publicly available on registry
April 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedDecember 22, 2017
December 1, 2017
4 years
March 28, 2014
December 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HRSD
The HRSD is a structured clinical interview for depression severity. Change from baseline measured at 2, 6, 12, and 24 weeks post workshop.
24 weeks
SCID-IV
Semi-structured clinical interview for depression. Change from baseline measured at 12 and 24 weeks post workshop.
24 weeks
Secondary Outcomes (3)
WHO-DAS-II
24 weeks
WHO-QOL
24 weeks
HDI
24 weeks
Other Outcomes (4)
AAQ-II
24 weeks
CPAQ
24 weeks
Demographics Questionnaire
1 day
- +1 more other outcomes
Study Arms (2)
ACT-ME
EXPERIMENTALACT-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 Only
EXPERIMENTALThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- migraines in the previous month
You may not qualify if:
- Bipolar, psychotic, or current substance use disorders
- History of brain injury
- Imminent suicidality.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Iowa Carver College of Medicine Department of Psychiatry
Iowa City, Iowa, 52242, United States
Related Publications (1)
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.
PMID: 31863406DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 28, 2014
First Posted
April 9, 2014
Study Start
September 1, 2013
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
December 22, 2017
Record last verified: 2017-12