Brief Behavioral Intervention for Comorbid Migraine and Depression

NCT01775852 | Completed Results

• 2 other identifiers: 201004763ICTS-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Depression

Keywords

Acceptance and Commitment Therapy (ACT); Depression; Illness Management; Behavioral treatment; Impairment

Outcome Measures

Primary Outcomes (1)

• Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 12 Week Follow-up

  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 Outcomes (3)

• Mean Change Score in HDI (Headache Disability Inventory) From Baseline to 12 Weeks.

  12 week change from baseline

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

  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.

  Change at 12 week follow-up from baseline

Study Arms (2)

ACT-IM

ACTIVE COMPARATOR

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

Waitlist/Treatment as Usual

NO INTERVENTION

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.

Interventions

ACT-IM BEHAVIORAL

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.

Also known as: Acceptance and Commitment Therapy, Illness Management

ACT-IM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75
• to 12 migraines in the previous month
• Major or Minor Depression
• English-speaking

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lilian N. Dindo: lead

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (10)

• Bigal ME, Lipton RB. The epidemiology, burden, and comorbidities of migraine. Neurol Clin. 2009 May;27(2):321-34. doi: 10.1016/j.ncl.2008.11.011.

  PMID: 19289218 BACKGROUND

• Breslau N, Lipton RB, Stewart WF, Schultz LR, Welch KM. Comorbidity of migraine and depression: investigating potential etiology and prognosis. Neurology. 2003 Apr 22;60(8):1308-12. doi: 10.1212/01.wnl.0000058907.41080.54.

  PMID: 12707434 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Gregg JA, Callaghan GM, Hayes SC, Glenn-Lawson JL. Improving diabetes self-management through acceptance, mindfulness, and values: a randomized controlled trial. J Consult Clin Psychol. 2007 Apr;75(2):336-43. doi: 10.1037/0022-006X.75.2.336.

  PMID: 17469891 BACKGROUND

• Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10.

  PMID: 27993338 BACKGROUND

• Lake AE 3rd, Rains JC, Penzien DB, Lipchik GL. Headache and psychiatric comorbidity: historical context, clinical implications, and research relevance. Headache. 2005 May;45(5):493-506. doi: 10.1111/j.1526-4610.2005.05101.x.

  PMID: 15953266 BACKGROUND

• Lundgren T, Dahl J, Melin L, Kies B. Evaluation of acceptance and commitment therapy for drug refractory epilepsy: a randomized controlled trial in South Africa--a pilot study. Epilepsia. 2006 Dec;47(12):2173-9. doi: 10.1111/j.1528-1167.2006.00892.x.

  PMID: 17201719 BACKGROUND

• McCracken LM, Vowles KE, Eccleston C. Acceptance-based treatment for persons with complex, long standing chronic pain: a preliminary analysis of treatment outcome in comparison to a waiting phase. Behav Res Ther. 2005 Oct;43(10):1335-46. doi: 10.1016/j.brat.2004.10.003. Epub 2005 Jan 7.

  PMID: 16086984 BACKGROUND

• Stronks DL, Tulen JH, Bussmann JB, Mulder LJ, Passchier J. Interictal daily functioning in migraine. Cephalalgia. 2004 Apr;24(4):271-9. doi: 10.1111/j.1468-2982.2004.00661.x.

  PMID: 15030535 BACKGROUND

Related Links

• Online, screening survey.
• University of Iowa Hospitals \& Clinics

MeSH Terms

Conditions

Migraine Disorders; Depression

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Lilian Dindo, PhD
• Organization: Baylor College of Medicine

lilian.dindo@bcm.edu

713-791-1414

Study Officials

• Lilian Dindo, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 25, 2013
• Study Start: August 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: August 1, 2013
• Last Updated: February 22, 2018
• Results First Posted: September 17, 2015

Record last verified: 2018-01

Locations

US (1)