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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
Tzu-Hsien Lai, Doctor, 886277380015, laitzuhsien@gmail.com
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.
- Conditions
- Medication Overuse Headache
- 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 group | Role | What they receive |
|---|---|---|
| CBT treatment | Experimental | Not 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.
- First posted21 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Overuse HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavior Therapy in Patients With Medication Overuse
- ClinicalTrials.gov ID
- NCT01754571
- Acronym / sponsor ID
- 101041-E
- Conditions
- Medication Overuse Headache
- Keywords
- medication overuse headache
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT treatment | Experimental | Behavioral: Cognitive behavior therapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Medication overuse headache
Key exclusion criteria (1 listed)
- other type headache
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavior therapyBehavior therapy, including Relaxation, cognitive rebuilding. | Behavioural | CBT treatment |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.