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Psychological Assessment and Treatment of Chronic Benign Headache

Primary Purpose

Headache, Migraine, Tension Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation training & thermal biofeedback
Surface EMG biofeedback
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache focused on measuring Relaxation Techniques, Behavior Therapy Feedback, Psychophysiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Veterans Affairs Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 3, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00018811
Brief Title
Psychological Assessment and Treatment of Chronic Benign Headache
Official Title
Psychological Assessment and Treatment of Chronic Benign Headache
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine, Tension Headache, Stress Headache, Vascular Headache
Keywords
Relaxation Techniques, Behavior Therapy Feedback, Psychophysiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Relaxation training & thermal biofeedback
Intervention Type
Behavioral
Intervention Name(s)
Surface EMG biofeedback

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Veterans Affairs Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904-6285
Country
United States

12. IPD Sharing Statement

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Psychological Assessment and Treatment of Chronic Benign Headache

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