Brief, Behavioral Intervention of ACT & Illness Management for Comorbid Migraine and Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Migraine
- Sponsor
- Lilian N. Dindo
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 12 Week Follow-up
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Lilian N. Dindo
Principal Investigator
University of Iowa
Eligibility Criteria
Inclusion Criteria
- •Age 18-75
- •4 to 12 migraines in the previous month
- •Major or Minor Depression
- •English-speaking
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 12 Week Follow-up
Time Frame: 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.
Secondary Outcomes
- 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)