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Brief Behavioral Intervention for Comorbid Migraine and Depression (ACT-IM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01775852
Recruitment Status : Completed
First Posted : January 25, 2013
Results First Posted : September 17, 2015
Last Update Posted : February 22, 2018
Information provided by (Responsible Party):
Lilian N. Dindo, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Migraine Depression Behavioral: ACT-IM Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brief, Behavioral Intervention of ACT & Illness Management for Comorbid Migraine and Depression
Study Start Date : August 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
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.
Behavioral: ACT-IM
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

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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Mean Change Score in HDI (Headache Disability Inventory) From Baseline to 12 Weeks. [ 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.

  2. Mean Change on Short Form Health Survey (SF-36) From Baseline to 12 Week Follow-up. [ 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.

  3. Mean Change of World Health Organization Disability Assessment (WHO-DAS) From Baseline to 12-week Follow up. [ 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01775852

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United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Lilian N. Dindo
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Principal Investigator: Lilian Dindo, PhD University of Iowa

Additional Information:
Blackledge, J.T. & Hayes, S.C. Using Acceptance and Commitment Training in the support of parents of children diagnosed with Autism. Child and Family Behavior Therapy. 2006;28(1):1-18.
Dahl, J., Wilson, K.G., Nilsson, A. Acceptance and Commitment Therapy and the treatment of persons at risk for long-term disability resulting from stress and pain symptoms: A preliminary randomized trial. Behavior Therapy. 2004;35:785-801.

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Responsible Party: Lilian N. Dindo, Principal Investigator, University of Iowa Identifier: NCT01775852    
Other Study ID Numbers: 201004763
ICTS-01 ( Other Grant/Funding Number: University of Iowa, ICTS )
First Posted: January 25, 2013    Key Record Dates
Results First Posted: September 17, 2015
Last Update Posted: February 22, 2018
Last Verified: January 2018
Keywords provided by Lilian N. Dindo, University of Iowa:
Acceptance and Commitment Therapy (ACT)
Illness Management
Behavioral treatment
Additional relevant MeSH terms:
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Migraine Disorders
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases