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

January 24, 2018 updated by: Lilian N. Dindo

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 week change from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 week change from baseline
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.
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.
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).
Change at 12 week follow-up from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lilian N. Dindo

Investigators

  • Principal Investigator: Lilian Dindo, PhD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 25, 2013

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201004763
  • ICTS-01 (Other Grant/Funding Number: University of Iowa, ICTS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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