Psychological Assessment and Treatment of Chronic Benign Headache

Migraine Clinical Trial

Official title:

Psychological Assessment and Treatment of Chronic Benign Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00018811
• Other study ID #: MHBS-001-99S2
• Status: Completed
• Phase: N/A
• First received: July 3, 2001
• Last updated: January 20, 2009
• Start date: April 1999
• Est. completion date: March 2003

Study information

• Verified date: December 2003
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Migraine
• Stress Headache
• Tension Headache
• Tension-Type Headache
• Vascular Headache
• Vascular Headaches

Intervention

Behavioral:
• Relaxation training & thermal biofeedback

• Surface EMG biofeedback

Locations

Country	Name	City	State
United States	Department of Veterans Affairs Medical Center	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,