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Psychological Assessment and Treatment of Chronic Benign Headache

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00018811
First Posted: July 5, 2001
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA Office of Research and Development
July 3, 2001
July 5, 2001
January 21, 2009
April 1999
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Complete list of historical versions of study NCT00018811 on ClinicalTrials.gov Archive Site
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Psychological Assessment and Treatment of Chronic Benign Headache
Psychological Assessment and Treatment of Chronic Benign Headache

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Headache
  • Migraine
  • Tension Headache
  • Stress Headache
  • Vascular Headache
  • Behavioral: Relaxation training & thermal biofeedback
  • Behavioral: Surface EMG biofeedback
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2003
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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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00018811
MHBS-001-99S2
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VA Office of Research and Development
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VA Office of Research and Development
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP