One-Day Intervention for Depression and Impairment in Migraine Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- SCID-IV
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Bipolar, psychotic, or current substance use disorders
- •History of brain injury
- •Imminent suicidality.
研究组 & 干预措施
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.
干预措施: ACT-ME (Behavioral)
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.
干预措施: Migraine Education Only (Behavioral)
结局指标
主要结局
SCID-IV
时间窗: 24 weeks
Semi-structured clinical interview for depression. Change from baseline measured at 12 and 24 weeks post workshop.
HRSD
时间窗: 24 weeks
The HRSD is a structured clinical interview for depression severity. Change from baseline measured at 2, 6, 12, and 24 weeks post workshop.
次要结局
- WHO-DAS-II(24 weeks)
- WHO-QOL(24 weeks)
- HDI(24 weeks)
研究者
Lilian Dindo
Professor
Baylor College of Medicine