Brief Behavioral Intervention for Comorbid Migraine and Depression (ACT-IM)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Brief, Behavioral Intervention of ACT & Illness Management for Comorbid Migraine and Depression|
- HAM-D [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The HAM-D is a structured clinical interview for depression severity.Change from Baseline in Hamilton Depression Rating Scale at 12 weeks
- HDI (Headache Disability Inventory) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
This is a self-report questionnaire used to determine the effectiveness of a management strategy over time.
Change from Baseline in HDI at 12 weeks
- SF-36 [ Time Frame: 12 week follow-up ] [ Designated as safety issue: No ]This is a self-report questionnaire used to measure physical and emotional health problems.
- WHO-DAS [ Time Frame: 12 week follow-up ] [ Designated as safety issue: No ]This is a self-report questionnaire that measures difficulties due to physical and mental health conditions.
- Structured Clinical Interview for DSM-IV Disorders (SCID-IV) [ Time Frame: 12-week follow-up ] [ Designated as safety issue: No ]Semi-structured clinical interview for Depression
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Active Comparator: ACT-IM
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.
1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and 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.
No Intervention: Waitlist/Treatment as Usual
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775852
|United States, Iowa|
|University of Iowa Hospitals & Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Lilian Dindo, PhD||University of Iowa|