Psychological Assessment and Treatment of Chronic Benign Headache

January 20, 2009 updated by: US Department of Veterans Affairs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30904-6285
        • Department of Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1999

Study Completion

March 1, 2003

Study Registration Dates

First Submitted

July 3, 2001

First Submitted That Met QC Criteria

July 4, 2001

First Posted (Estimate)

July 5, 2001

Study Record Updates

Last Update Posted (Estimate)

January 21, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHBS-001-99S2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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