CBT in Patients With Medication Overuse Headache

Medication Overuse Headache Clinical Trial

Official title:

Cognitive Behavior Therapy in Patients With Medication Overuse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01754571
• Other study ID #: 101041-E
• Status: Recruiting
• Phase: Phase 0
• First received: August 15, 2012
• Last updated: December 20, 2012
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: November 2012
• Source: Far Eastern Memorial Hospital
• Contact: Tzu-Hsien Lai, Doctor
• Phone: 88677380015
• Email: laitzuhsien[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Medication overuse headache

Exclusion Criteria:

• other type headache

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Headache Disorders, Secondary
• Medication Overuse Headache

Intervention

Behavioral:
• Cognitive behavior therapy
Behavior therapy, including Relaxation, cognitive rebuilding.

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan,