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CBT in Patients With Medication Overuse Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01754571
Recruitment Status : Unknown
Verified November 2012 by Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : December 21, 2012
Last Update Posted : December 21, 2012
Information provided by (Responsible Party):
Far Eastern Memorial Hospital

Brief Summary:

According to the definition from International Headache Society, medication overuse headache (MOH) is diagnosed when patients takes painkillers for more than 10 or 15 days per month (depending on what kind of painkillers being used), for more than 3 months, which results in the deterioration of headache. The treatments of MOH include preventive medication of headache and withdrawal of the overused painkillers. Other than the simple oral advice, some researchers recommended non-pharmacological methods. Pryse-Phillips et al. (1998) reviewed the the treatment of migraine and suggested that biofeedback, relaxation, cognitive behavior therapy (CBT), psychological therapy, hypnosis and physical treatment are effective. Researches also point out CBT is effective on withdrawing medication in patients with MOH (Kroner-Herwig, 2009). Lake (2006) reported that behavioural therapy maybe an adjunct therapy to preventive medication to reduce the relapse rate of medication overuse.

The purpose of this study is to confirm the effect of CBT in patients with MOH. The target is to reduce the frequency of headache and use of painkillers. Patients could benefit from the education and relaxation training during CBT to cope with headache and reduce the use of painkillers.

The research will recruit 60 patients with MOH at Neurology Clinics, Far Eastern Memorial Hospital. They will be separated into two groups, 30 in control group and the other 30 in the experimental group. Education of MOH, relaxation and cognitive restructuring would be included in the four weeks training program. The training program is under the supervision of a neurologist from Far Eastern Memorial Hospital and a psychology professor from Fu Jen Catholic University. The control group will accept four weeks telephone interview to confirm their headache diary including the frequency of headache and use of painkillers. The frequency of headache and medication use will be used for analyzing the effect of CBT.

Condition or disease Intervention/treatment Phase
Medication Overuse Headache Behavioral: Cognitive behavior therapy Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cognitive Behavior Therapy in Patients With Medication Overuse
Study Start Date : July 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CBT treatment Behavioral: Cognitive behavior therapy
Behavior therapy, including Relaxation, cognitive rebuilding.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of Medication overuse headache

Exclusion Criteria:

  • other type headache

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01754571

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Contact: Tzu-Hsien Lai, Doctor 88677380015

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Far Eastern Memorial Hospital Recruiting
New Taipei City, Taiwan, 220
Contact: Tzu-Hsien Lai, Doctor    886277380015   
Sponsors and Collaborators
Far Eastern Memorial Hospital
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Responsible Party: Far Eastern Memorial Hospital Identifier: NCT01754571    
Other Study ID Numbers: 101041-E
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: November 2012
Keywords provided by Far Eastern Memorial Hospital:
medication overuse headache
Additional relevant MeSH terms:
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Headache Disorders, Secondary
Neurologic Manifestations
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases