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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01775852
First received: January 9, 2012
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Migraine
Depression
Behavioral: ACT-IM
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 93
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775852

Locations
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Lilian Dindo, PhD University of Iowa
  More Information

Additional Information:
Publications:
Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01775852     History of Changes
Other Study ID Numbers: 201004763, ICTS-01
Study First Received: January 9, 2012
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Acceptance and Commitment Therapy (ACT)
Depression
Illness Management
Behavioral treatment
Impairment

Additional relevant MeSH terms:
Depression
Depressive Disorder
Migraine Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014