The proposed study evaluates the effectiveness of preventive drug (beta-blocker) therapy and non-drug (behavioral migraine management) therapies for frequent migraine, both separately and when combined.
The specific aims are to: (1) Evaluate the separate and combined effects of Preventive Drug Therapy and limited-contact Behavioral Migraine Management, with reference to Placebo in a (n=220) prospective outcome study; (2) Evaluate the effectiveness of these treatments of individuals with frequent (4-15 migraine days/month) disabling (above the population median in disability) migraine; (3) Evaluate the effects of these treatments on multiple outcome measures, including migraine activity, disability, quality of life, psychological symptoms and beliefs about migraines; (4) Evaluate the effects of these treatments on the use, effectiveness and cost of acute (5HT1 antagonist) therapy; (5) Evaluate intermediate (6 months) and long-term (1-year) treatment effects. Examine psychological variables hypothesized to be associated with the maintenance of treatment effects. Two hundred twenty patients meeting International Headache Society (Olesen, 1988) diagnostic criteria for migraine (w or w/o aura) and who experience frequent (4 to 15 migraine/days month) and disabling (above the median of migraine sufferers in disability) migraine will participate in the following three phases of this study: (1) pretreatment evaluation that includes structured diagnostic and psychosocial interview, neurological evaluation, psychosocial testing and at least 5 weeks baseline daily monitoring of migraine activity, migraine-related disability and medication use; (2) a three-month treatment (administration/dose adjustment) phase where standard acute therapy plus one of the following four preventive therapies are administered in a 2 x 2 factorial design: Preventive Drug Therapy with beta-blockers, or Preventive Drug Therapy with placebo, or Behavioral Migraine Management Therapy + beta blockers, or Behavioral Migraine Management + placebo and, (3) a 12-month long evaluation phase where continuing care is provided and treatment efficacy is assessed at 1-month, 6-months and 12-months follow follow-up evaluations (with neurological & psychosocial evaluations and 5 additional weeks of daily headache, disability and medication recordings).

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
2R01NS032374-06
Application #
6042871
Study Section
Special Emphasis Panel (ZRG1-RPHB-3 (01))
Program Officer
Marler, John R
Project Start
1994-09-30
Project End
2005-08-31
Budget Start
2000-09-28
Budget End
2001-08-31
Support Year
6
Fiscal Year
2000
Total Cost
$524,113
Indirect Cost
Name
Ohio University Athens
Department
Psychology
Type
Schools of Arts and Sciences
DUNS #
City
Athens
State
OH
Country
United States
Zip Code
45701
Grinberg, Amy S; Seng, Elizabeth K (2017) Headache-Specific Locus of Control and Migraine-Related Quality of Life: Understanding the Role of Anxiety. Int J Behav Med 24:136-143
Minen, Mia T; Seng, Elizabeth K; Holroyd, Kenneth A (2014) Influence of family psychiatric and headache history on migraine-related health care utilization. Headache 54:485-92
Seng, Elizabeth K; Holroyd, Kenneth A (2012) Psychiatric comorbidity and response to preventative therapy in the treatment of severe migraine trial. Cephalalgia 32:390-400
Seng, Elizabeth K; Holroyd, Kenneth A (2010) Dynamics of changes in self-efficacy and locus of control expectancies in the behavioral and drug treatment of severe migraine. Ann Behav Med 40:235-47
Pinkerman, Brenda; Holroyd, Kenneth (2010) Menstrual and nonmenstrual migraines differ in women with menstrually-related migraine. Cephalalgia 30:1187-94
Holroyd, Kenneth A; Cottrell, Constance K; O'Donnell, Francis J et al. (2010) Effect of preventive (beta blocker) treatment, behavioural migraine management, or their combination on outcomes of optimised acute treatment in frequent migraine: randomised controlled trial. BMJ 341:c4871
Holroyd, Kenneth A; Labus, Jenifer S; Carlson, Bruce (2009) Moderation and mediation in the psychological and drug treatment of chronic tension-type headache: the role of disorder severity and psychiatric comorbidity. Pain 143:213-22
Holroyd, K A; Drew, J B; Cottrell, C K et al. (2007) Impaired functioning and quality of life in severe migraine: the role of catastrophizing and associated symptoms. Cephalalgia 27:1156-65
Cottrell, Constance; Drew, Jana; Gibson, Jessica et al. (2007) Feasibility assessment of telephone-administered behavioral treatment for adolescent migraine. Headache 47:1293-302
Creer, Thomas L; Holroyd, Kenneth A (2006) Self-management of chronic conditions: the legacy of Sir William Osler. Chronic Illn 2:7-14

Showing the most recent 10 out of 25 publications