Psychological Assessment and Treatment of Chronic Benign Headache - Tabular View

Tracking Information
First Received Date ^ICMJE	July 3, 2001
Last Updated Date	January 20, 2009
Start Date ^ICMJE	April 1999
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00018811 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Psychological Assessment and Treatment of Chronic Benign Headache
Official Title ^ICMJE	Psychological Assessment and Treatment of Chronic Benign Headache
Brief Summary	Subjects with chronic migraine or tension headaches will receive 12 sessions of biofeedback or relaxation training after fulfilling screening, intake interviews, & psychological testing requirements. They will chart headache pain, anger level, & medication usage throughout baseline, treatment, and 3 month follow-up periods. Migraine sufferers will receive a combination of progressive muscle relaxation training and thermal biofeedback (learning to warm hands). Subjects are randomly assigned to receive treatment either in the office with the therapist or from another room (where communication will be over a computer). The research is designed to compare the effectiveness of treatment based on location. Tension headache sufferers will receive training in how to reduce their muscle tension levels. They will be randomly assigned to have equipment monitor muscle tension levels either in the forehead or shoulder regions. The research is designed to compare the effectiveness of feedback to the forehead versus the shoulder muscles.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Headache Migraine Tension Headache Stress Headache Vascular Headache
Intervention ^ICMJE	Behavioral: Relaxation training & thermal biofeedback Behavioral: Surface EMG biofeedback
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	March 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	Subjects must be at least 18 years old and have chronic headaches of any of the following types: migraine, coexisting migraine/tension, or tension. Participants must be intellectually intact and have no significant physical, neurological, or psychological problems. They must have seen a physician for their headaches within the past year. They must successfully complete screening/interview/testing process prior to admission to treatment. All vascular headache subjects must meet the criteria for chronic migraine or coexisting migraine and tension type headache as set forth by the Headache Classification Committee of the International Headache Society. All tension headache subjects must meet the criteria for either episodic or chronic tension headache set forth by the Headache Classification Committee, as well as the Ad Hoc Committee's criteria for tension headache.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00018811
Responsible Party
Study ID Numbers ^ICMJE	MHBS-001-99S2
Study Sponsor ^ICMJE	Department of Veterans Affairs
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Department of Veterans Affairs
Verification Date	December 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP