University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
NCT Number: NCT01775852
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Iowa City, Iowa, 52242, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Acceptance and Commitment Therapy, Illness Management
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.
Time frame: 12 week change from baseline
The HDI is useful in assessing the impact of headache, and its treatment, on daily living. 25 self-report items are rated with answers as "Yes" (4 points), "Sometimes" (2 Points), and "No" (0 points). All items are then added together to create an overall score which can range from 0 (no impact), to 100 (severe impact) of headache on daily life.
A 29 point change (95% confidence interval) or greater in the total score from test to retest must occur before the change can be attributed to treatment effects.
Time frame: Change at 12 week follow-up from baseline
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Change at 12 week follow-up from baseline
The WHODAS contains 36 items on functioning and disability with a recall period of 30 days covering 7 domains: Understanding and Communicating (6 items), Getting around (5 items), Self-care (4 items), Getting along with others (5 items), Life activities: household (4 items), Life activities: work/school (4 items), and Participation in society (8 items). Response options go from 1 (no difficulty) to 5 (extreme difficulty or can not do).
WHODAS domain scores are computed for each domain by adding the item responses together. A global score is then computed by summing all domains together, and transforming them into a range from 0 to 100, with higher scores indicating higher levels of disability (0= no disability, 100= full disability).
Lilian N. Dindo
Other
Brief, Behavioral Intervention of ACT & Illness Management for Comorbid Migraine and Depression
Acronym: ACT-IM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04992494
Behavior, Behavioral Symptoms
New York, United States
View Trial DetailsNCT01854580
Allergic Rhinitis, Asthma
Berlin, Germany
View Trial DetailsNCT02108678
Behavior, Behavioral Symptoms
Iowa City, Iowa, United States
View Trial DetailsNCT07579481
Behavior, Behavioral Symptoms
Rome, Lazio, Italy
View Trial Details