CBT in Patients With Medication Overuse Headache
Primary Purpose
Medication Overuse Headache
Status
Unknown status
Phase
Early Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Cognitive behavior therapy
Sponsored by
About this trial
This is an interventional treatment trial for Medication Overuse Headache focused on measuring medication overuse headache
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Medication overuse headache
Exclusion Criteria:
- other type headache
Sites / Locations
- Far Eastern Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CBT treatment
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01754571
First Posted
August 15, 2012
Last Updated
December 20, 2012
Sponsor
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01754571
Brief Title
CBT in Patients With Medication Overuse Headache
Official Title
Cognitive Behavior Therapy in Patients With Medication Overuse
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Far Eastern Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Overuse Headache
Keywords
medication overuse headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBT treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy
Intervention Description
Behavior therapy, including Relaxation, cognitive rebuilding.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Medication overuse headache
Exclusion Criteria:
other type headache
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tzu-Hsien Lai, Doctor
Phone
88677380015
Email
laitzuhsien@gmail.com
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tzu-Hsien Lai, Doctor
Phone
886277380015
Email
laitzuhsien@gmail.com
12. IPD Sharing Statement
Learn more about this trial
CBT in Patients With Medication Overuse Headache
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