One-Day Intervention for Depression and Impairment in Migraine Patients (ACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Iowa
Sponsor:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT02108678
First received: March 28, 2014
Last updated: May 5, 2014
Last verified: September 2013
  Purpose

The purpose of this research study is to examine whether a one-day group workshop, integrating principles from Acceptance and Commitment Therapy and Migraine Education, will result in greater improvements in depressive symptoms and functioning impairment in patients with comorbid migraine and depression than a similar one-day group workshop with Migraine Education only.


Condition Intervention
Migraine
Depression
Behavioral: ACT-ME
Behavioral: Migraine Education Only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: One-Day Intervention for Depression and Impairment in Migraine Patients

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • HRSD [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The HRSD is a structured clinical interview for depression severity. Change from baseline measured at 2, 6, 12, and 24 weeks post workshop.

  • SCID-IV [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Semi-structured clinical interview for depression. Change from baseline measured at 12 and 24 weeks post workshop.


Secondary Outcome Measures:
  • WHO-DAS-II [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    This is a self-report questionnaire that measures difficulties due to physical and mental health conditions. Measure change from baseline at 12 and 24 weeks post-workshop.

  • WHO-QOL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The WHO-QOL is a self-report measure that assesses four domains of quality of life: physical health, psychological well-being, social relationships, and environment. Measure change from baseline at 12 and 24 weeks post workshop.

  • HDI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The HDI is a self-report measure that assesses the burden of headaches through perceived impact of headaches on functioning. Measure changes from baseline at 12 and 24 weeks post workshop.


Other Outcome Measures:
  • AAQ-II [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The AAQ-II is a self-report measure that assesses experiential avoidance, or the tendency to avoid unwanted internal experiences (e.g., "I try hard to avoid feeling depressed or anxious"), as well as acceptance, the term used to describe the counter process (e.g., "My thoughts and feelings do not get in the way of how I want to live my life"). Measure changes from baseline at 2, 6, 12, and 24 weeks post workshop.

  • CPAQ [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The CPAQ is a self-report measure that assesses Activity Engagement, the degree to which one engages in life activities regardless of pain, and Pain Willingness, the willingness to have pain without trying to avoid or reduce it. Measure change from baseline at 2, 6, 12, and 24 weeks post workshop.

  • CPVI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The CPVI is a self-report measure that assesses values-based behavioral activation in chronic pain. Respondents rate their success in living according to six domains of values: family, intimate relations, friends, work, health, and growth or learning. Measure changes from baseline at 2, 6, 12, and 24 weeks post workshop.

  • GCQ [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The GCQ is a self-report measure that assesses individual group members' perceptions of the group's therapeutic environment. Measure change from baseline at 2 weeks post workshop.

  • CSQ [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    This self-report measure assesses perceived effectiveness and satisfaction with treatment. Measure change from baseline at 2 weeks post workshop.

  • Demographics Questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The following information will be obtained: age, ethnicity, marital status, educational level, household income, occupation, current mental health treatment, current medication, number of migraines in previous month, and age of onset of migraine. Information will only be obtained at initial meeting.

  • Treatment Questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes in medications and involvement in psychotherapy/counseling will be documented at each contact and will be confirmed by reviewing medical and pharmacy records. Measured at baseline and 2, 6, 12, and 24 weeks post workshop.


Estimated Enrollment: 104
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACT-ME
ACT-ME is designed to reduce behavioral avoidance and to enhance acceptance-based coping. It includes: 1) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 2) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations; and 3) Migraine education whereby each of the educational topics listed below will be covered without detailed discussion of the topics.
Behavioral: ACT-ME
1 hour discussion about migraine education (ME) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). Migraine education covers topics including migraine symptoms, 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 Name: Acceptance and Commitment Training Plus Migraine Education
Experimental: Migraine Education Only
The MEO workshop will last six hours and involve educating participants about migraine, its natural course, its prodromal symptoms and triggers for symptom worsening, risk for migraine chronification, how to use abortive migraine medications, medication overuse headache, medical and psychological treatments of migraine, migraine comorbidity, and menstrual migraine. The group leaders will present one educational topic at a time and the participants will discuss and reflect about issues and experiences related to the topic. If necessary, the group leaders will raise specific discussion questions to facilitate group dialogue and participant involvement. However, information on coping practices will be omitted.
Behavioral: Migraine Education Only
6 hour discussion of migraine education only (MEO). This will involve educating participants about migraine, its natural course, its prodromal symptoms and triggers for symptom worsening, risk for migraine chronification, how to use abortive migraine medications, medication overuse headache, medical and psychological treatments of migraine, migraine comorbidity, and menstrual migraine.
Other Name: Illness Management

Detailed Description:

Adults with comorbid depression and migraine will be randomized to a 1-day (6-hour) workshop of Acceptance and Commitment Training + Migraine Education (ACT-ME) or Migraine Education only (MEO). The intervention delivered to both study arms will be identical except for the addition of the ACT component delivered in the ACT-ME condition, thereby allowing an estimate of the specific additive effect of the psychotherapy. Measures of acceptance and behavioral avoidance, theoretically important mechanisms of change, will be used to test intervention components by examining whether these processes are uniquely affected by the ACT-ME intervention and whether they account for observed treatment effects. The central hypothesis is that the ACT-ME treatment will lead to significantly greater reduction in depression (HRSD) and disability (WHO-DAS, WHOQOL, and HDI) at follow-up compared to the MEO treatment. ACT-ME participants also are expected to demonstrate reductions in behavioral avoidance and enhanced acceptance, which mediate treatment effects. Treatment gains are expected to be maintained through the 6-month follow-up.

Aim 1: To examine the efficacy of a 1-day ACT-ME intervention compared to MEO for treating depression in patients with comorbid depression and migraine.

Hypothesis 1: At 3- and 6-month follow-up, ACT-ME will be more efficacious than MEO as assessed by: 1) a significantly greater decline on the Hamilton Rating Scale for Depression (HRSD) total score; 2) a significantly higher proportion of participants showing 50% or greater decline on the HRSD; and 3) a significantly higher proportion of participants no longer meeting depression criteria on SCID-IV.

Aim 2: To examine the efficacy of a 1-day ACT-ME intervention compared to MEO on functioning in patients with comorbid depression and migraine.

Hypothesis 2: At 3- and 6-month follow-up, compared to the MEO group, participants in the ACT-ME group will exhibit significantly greater improvement in functioning (measured by World Health Organization Disability Assessment Schedule-Total Score; WHO-DAS) and quality of life (measured by World Health Organization Quality of Life Total; WHO-QOL), and greater decline in headache-related disability (measured by Headache Disability Inventory; HDI).

Aim 3: To determine whether changes in acceptance-based coping and behavioral avoidance will mediate the changes in depressive symptoms and disability.

Hypothesis 3: Increases in acceptance-based coping and reductions in behavioral avoidance will mediate relations between treatment group and 1) decline in depressive symptoms as measured by the HRSD and 2) disability, as measured by the WHO-DAS and HDI. Acceptance and Behavioral Avoidance will be measured using the Acceptance and Action Questionnaire and Chronic Pain Acceptance Questionnaire.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18-65
  • Current major depressive episode on the SCID-IV (46)
  • Score of ≥ 17 on the HRSD (47)
  • Confirmation of diagnosis of migraine from medical record
  • 4-12 migraines in the previous month

Exclusion Criteria:

  • Bipolar, psychotic, or current substance use disorders
  • History of brain injury
  • Imminent suicidality.
  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: NCT02108678

Contacts
Contact: Lilian N Dindo, PhD 3193534444
Contact: James Marchman, PhD 3193352467

Locations
United States, Iowa
University of Iowa Carver College of Medicine Department of Psychiatry Recruiting
Iowa City, Iowa, United States, 52242
Contact: Lilian N Dindo, PhD    319-353-4444      
Principal Investigator: Lilian N Dindo, PhD         
Sponsors and Collaborators
University of Iowa
  More Information

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT02108678     History of Changes
Other Study ID Numbers: 5k23MH097827-02
Study First Received: March 28, 2014
Last Updated: May 5, 2014
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:
Migraine Disorders
Depression
Depressive Disorder
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 October 01, 2014