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CompletedNCT00018811Updated Jan 21, 2009

Psychological Assessment and Treatment of Chronic Benign Headache

An interventional study of Relaxation training & thermal biofeedback and Surface EMG biofeedback in Headache, Migraine and Tension Headache, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-01-21.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Headache
  • Migraine
  • Tension Headache
  • Stress Headache
  • Vascular Headache

Keywords

  • Relaxation Techniques
  • Behavior Therapy Feedback
  • Psychophysiology
03

In context

Tension-Type Headache

144 studies on the registry are indexed under Tension-Type Headache; 41 are open to participants now.

Browse Tension-Type Headache studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Interventions

  • BehavioralRelaxation training & thermal biofeedback
  • BehavioralSurface EMG biofeedback
06

Study locations

1 site
  • Department of Veterans Affairs Medical Center
    Augusta, Georgia 30904-6285, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00018811
Lead sponsor
US Department of Veterans Affairs
First posted
Jul 5, 2001
Start date
Apr 1999
Completion
Mar 2003
Last update
Jan 21, 2009
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2003. You cannot join it, but the record below documents what was studied.

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