CBT in Patients With Medication Overuse Headache

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Far Eastern Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01754571
First received: August 15, 2012
Last updated: December 20, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Medication Overuse Headache
Behavioral: Cognitive behavior therapy
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Cognitive Behavior Therapy in Patients With Medication Overuse

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT treatment Behavioral: Cognitive behavior therapy
Behavior therapy, including Relaxation, cognitive rebuilding.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Medication overuse headache

Exclusion Criteria:

  • other type headache
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754571

Contacts
Contact: Tzu-Hsien Lai, Doctor 88677380015 laitzuhsien@gmail.com

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
New Taipei City, Taiwan, 220
Contact: Tzu-Hsien Lai, Doctor    886277380015    laitzuhsien@gmail.com   
Sponsors and Collaborators
Far Eastern Memorial Hospital
  More Information

No publications provided

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01754571     History of Changes
Other Study ID Numbers: 101041-E
Study First Received: August 15, 2012
Last Updated: December 20, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Far Eastern Memorial Hospital:
medication overuse headache

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014