An interventional study of ACT-ME and Migraine Education Only in Migraine and Depression, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-12-22.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
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.
Adults with comorbid depression and migraine will be randomized to a 1-day (6-hour) workshop of Acceptance and Commitment Training + Migraine Education (ACT-ME) or Migraine Education only (MEO). The intervention delivered to both study arms will be identical except for the addition of the ACT component delivered in the ACT-ME condition, thereby allowing an estimate of the specific additive effect of the psychotherapy. Measures of acceptance and behavioral avoidance, theoretically important mechanisms of change, will be used to test intervention components by examining whether these processes are uniquely affected by the ACT-ME intervention and whether they account for observed treatment effects. The central hypothesis is that the ACT-ME treatment will lead to significantly greater reduction in depression (HRSD) and disability (WHO-DAS, WHOQOL, and HDI) at follow-up compared to the MEO treatment. ACT-ME participants also are expected to demonstrate reductions in behavioral avoidance and enhanced acceptance, which mediate treatment effects. Treatment gains are expected to be maintained through the 6-month follow-up.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 104 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
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Exclusion Criteria:
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.
Behavioral: ACT-ME
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.
Behavioral: Migraine Education Only
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.
Also known as: Acceptance and Commitment Training Plus Migraine Education
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.
Also known as: Illness Management
HRSD
The HRSD is a structured clinical interview for depression severity. Change from baseline measured at 2, 6, 12, and 24 weeks post workshop.
Time frame: 24 weeks
SCID-IV
Semi-structured clinical interview for depression. Change from baseline measured at 12 and 24 weeks post workshop.
Time frame: 24 weeks
WHO-DAS-II
This is a self-report questionnaire that measures difficulties due to physical and mental health conditions. Measure change from baseline at 12 and 24 weeks post-workshop.
Time frame: 24 weeks
WHO-QOL
The WHO-QOL is a self-report measure that assesses four domains of quality of life: physical health, psychological well-being, social relationships, and environment. Measure change from baseline at 12 and 24 weeks post workshop.
Time frame: 24 weeks
HDI
The HDI is a self-report measure that assesses the burden of headaches through perceived impact of headaches on functioning. Measure changes from baseline at 12 and 24 weeks post workshop.
Time frame: 24 weeks
AAQ-II
The AAQ-II is a self-report measure that assesses experiential avoidance, or the tendency to avoid unwanted internal experiences (e.g., "I try hard to avoid feeling depressed or anxious"), as well as acceptance, the term used to describe the counter process (e.g., "My thoughts and feelings do not get in the way of how I want to live my life"). Measure changes from baseline at 2, 6, 12, and 24 weeks post workshop.
Time frame: 24 weeks
CPAQ
The CPAQ is a self-report measure that assesses Activity Engagement, the degree to which one engages in life activities regardless of pain, and Pain Willingness, the willingness to have pain without trying to avoid or reduce it. Measure change from baseline at 2, 6, 12, and 24 weeks post workshop.
Time frame: 24 weeks
Demographics Questionnaire
The following information will be obtained: age, ethnicity, marital status, educational level, household income, occupation, current mental health treatment, current medication, number of migraines in previous month, and age of onset of migraine. Information will only be obtained at initial meeting.
Time frame: 1 day
Treatment Questionnaire
Changes in medications and involvement in psychotherapy/counseling will be documented at each contact and will be confirmed by reviewing medical and pharmacy records. Measured at baseline and 2, 6, 12, and 24 weeks post workshop.
Time frame: 24 weeks
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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