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Medication Overuse HeadacheEarly Phase 1NCT01754571

CBT in Patients With Medication Overuse Headache

A Early Phase 1 study testing Cognitive behavior therapy in people with Medication Overuse Headache, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Medication Overuse Headache
What is being tested?
Cognitive behavior therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
Jul 2012to Jun 2013
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of Medication overuse headache

Who cannot join

  • other type headache

Trial locations and contacts

1 site in 1 country.

Tzu-Hsien Lai, Doctor contact

88677380015

laitzuhsien@gmail.com

Taiwan1 site, 1 recruiting
  • Far Eastern Memorial Hospital

    New Taipei City, 220

    Tzu-Hsien Lai, Doctor, 886277380015, laitzuhsien@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: Cognitive Behavior Therapy in Patients With Medication Overuse

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.

Being tested
Cognitive behavior therapy
Keywords
medication overuse headache
Medical subject headings
Headache Disorders, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive behavior therapyBehavioural

    Behavior therapy, including Relaxation, cognitive rebuilding.

Study groups in NCT01754571
Study groupRoleWhat they receive
CBT treatmentExperimentalNot described
Receives: Behavioral: Cognitive behavior therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJun 2013 (estimated)
  4. Study completionJun 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01754571
Sponsor's protocol ID
101041-E
Status last verified
Nov 2012
First submitted
15 Aug 2012
Last updated
21 Dec 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Cognitive behavior therapy in people with Medication Overuse Headache, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tzu-Hsien Lai, Doctor (88677380015, laitzuhsien@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2012.

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