Psychological Assessment and Treatment of Chronic Benign Headache

NCT00018811 | Completed

• 1 other identifier: MHBS-001-99S2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Migraine; Tension Headache; Stress Headache; Vascular Headache

Keywords

Relaxation Techniques; Behavior Therapy Feedback; Psychophysiology

Interventions

Relaxation training & thermal biofeedback BEHAVIORAL

Surface EMG biofeedback BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Department of Veterans Affairs Medical Center

Augusta, Georgia, 30904-6285, United States

Location

MeSH Terms

Conditions

Headache; Migraine Disorders; Tension-Type Headache; Vascular Headaches

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Headache Disorders, Secondary; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 3, 2001
• First Posted: July 5, 2001
• Study Start: April 1, 1999
• Study Completion: March 1, 2003
• Last Updated: January 21, 2009

Record last verified: 2003-12

Locations

US (1)