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临床试验/NCT01775852
NCT01775852已完成不适用

Brief, Behavioral Intervention of ACT & Illness Management for Comorbid Migraine and Depression

Lilian N. Dindo1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2010年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 12 Week Follow-up

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 with Migraine Education, will result in improvements in depressive symptoms and functioning impairment in patients with comorbid migraine and depression.

详细描述

Migraine affects approximately 35 million US residents (Bigal & Lipton, 2009) and is associated with excruciating headache and marked functional impairment. Epidemiological and clinical research has shown that people with migraine suffer from psychiatric disorders at a disproportionately higher rate than individuals without. Depression, in particular, is 3-5 times more common in migraine patients than in non-migraineurs. The comorbidity of depression and migraine is a major health concern as it results in poorer prognosis, remission rate, and response to treatment. In addition, an increase in the severity of migraine is associated with a parallel rise in the severity and treatment resistance of comorbid depression.

Recent research in behavioral medicine suggests that the pain experience per se does not necessarily lead to depression or impairment. Instead, it is the preoccupation with avoiding aversive stimuli associated with pain (i.e., activities, places, movements) that results in depression and disability (e.g., McCracken et al., 2005). Therefore, given that patients with migraine and/or depression exhibit more avoidance behaviors and lower activity levels than healthy controls (e.g., Stronks et al., 2004), an intervention aimed at optimizing willingness and acceptance and minimizing behavioral avoidance may be beneficial at improving both their depression and migraine and, consequently, their daily functioning.

Acceptance and Commitment Therapy (ACT) is an empirically based behavioral therapy that incorporates acceptance and mindfulness strategies with behavioral change strategies. ACT (in group and in individual settings) is effective in treating psychiatric disorders commonly associated with migraine, including depression, anxiety, and stress (e.g., Hayes, 2001) as well as chronic illnesses like pain and diabetes (Dahl et al, 2004; Gregg et al., 2006). Importantly, ACT resulted in positive long-term outcomes even when presented in brief form. For example, a two-day ACT workshop, in a group setting, led to improvements in depression and distress experienced by parents of children diagnosed with autism and these gains were retained 3 months later. Parents also exhibited a reduction in avoidance behaviors (Blackledge & Hayes, 2006).

研究设计

研究类型
Interventional
分配方式
Non 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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-75
  • •4 to 12 migraines in the previous month
  • •Major or Minor Depression
  • •English-speaking

排除标准

  • •Patients with other major psychiatric disorders such as bipolor disorder, schizophrenia, and current illicit drug use.
  • •Patients with major head injuries.
  • •Patients with serious medical illnesses.
  • •Patients who have started a new medication in previous 4 weeks or plan on starting a new medication in the next 4 weeks.
  • •Patients expressing significant suicidal ideation.

研究组 & 干预措施

ACT-IM

Active Comparator

The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.

干预措施: ACT-IM (Behavioral)

Waitlist/Treatment as Usual

No Intervention

The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.

结局指标

主要结局

Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 12 Week Follow-up

时间窗: 12 week change from baseline

The HAM-D is a structured clinical interview for assessing depression severity. Outcome measure will be change from Baseline in Hamilton Depression Rating Scale at 12 week (3 month) follow-up from baseline. Measure is scored by adding individual items and attaining an overall severity score. Scores range from 0 to 53, with higher values signifying a higher level of depression severity (and thus a worse outcome). A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.

次要结局

  • Mean Change Score in HDI (Headache Disability Inventory) From Baseline to 12 Weeks.(12 week change from baseline)
  • Mean Change on Short Form Health Survey (SF-36) From Baseline to 12 Week Follow-up.(Change at 12 week follow-up from baseline)
  • Mean Change of World Health Organization Disability Assessment (WHO-DAS) From Baseline to 12-week Follow up.(Change at 12 week follow-up from baseline)

研究者

发起方
Lilian N. Dindo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lilian N. Dindo

Principal Investigator

University of Iowa

研究点 (1)

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