Migraine DisordersNCT04743492
Pain Resilience and Holistic Health Care of Migraine
A study testing cognitive behavioral therapy in people with Migraine Disorders, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate how pain resilience (as a personality characteristic or a strength) moderate the efficacy of treatment for patients with migraine. The primary objective of the current study is to explore the moderation effect of pain resilience between initial pain and the treatment outcome… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Apr 2021to May 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with migraine
Who cannot join
- uncontrolled hypertension
- coronary artery disease
- arrhythmia
- secondary headache(except for medication overuse headache)a
- age under 20
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Pain Resilience Determines the Efficacy of Holistic Health Care of Patients With Migraine
The purpose of this study is to investigate how pain resilience (as a personality characteristic or a strength) moderate the efficacy of treatment for patients with migraine.
The primary objective of the current study is to explore the moderation effect of pain resilience between initial pain and the treatment outcome of the holistic healthcare programs. The investigators hypothesize that participants with higher level of pain resilience will show more improvements in the quality of life, less disability (assessed with the Migraine Disability Assessment Test, MIDAS), less frequency and lower severity of pain, and higher heart-rate variability after training. A secondary finding that can be obtained through the study is the comparison between the enhancement of heart rate variability in participants receiving different kinds of non-pharmacological therapies.
Read the detailed description
Introduction：A multi-national research that included data from Taiwan found that chronic headache is one of the top two disorders (alongside with chronic low back pain) with the most patients having longest years of living with disabilities through year 1999 to 2017. It does not only impact a sufferer's ability to work, but also limit one's participation in a variety of daily housework, leisure activities, etc. Quality of life is also impacted. According to a systematic review on behavioral interventions for migraine, cognitive behavioral therapy (CBT) is one of the most common non-pharmacological practices implemented and studied. CBT has been found to be effective in reducing the intensity and frequency of headache, compared to waitlist controls. Another commonly discussed non-pharmacological treatment for migraine is exercise therapy.
In regard to the controversial findings from therapeutic clinical trials, the unsolved puzzle is: why do some show improvements while the others remained unchanged or worse? It is found that psychological resilience for pain can be a determining factor in task persistence despite the interruption of pain. Pain resilience specifically refers to the cognitive and behavioral aspects of an individual when one is trying to deal with pain. In a study investigating negative pain beliefs (i.e. fear avoidance and pain catastrophizing) and pain outcomes (functional and movement aspects), pain resilience was found to moderate the relationship between pain beliefs and pain outcomes. The authors found that only in individuals with low level of pain resilience was the negative pain beliefs related to greater movement-relate pain. Since pain resilience is such an important capacity/ dynamic process in coping with chronic pain, the current study aims at investigating how pain resilience can be a moderating factor determining the outcome of pain management in patients with migraine.
Objectives：The primary objective of the current study is to explore the moderation effect of pain resilience between initial pain and the treatment outcome of the holistic healthcare programs. The investigators hypothesize that participants with higher level of pain resilience will show more improvements in the quality of life, less disability (assessed with MIDAS), less frequency and lower severity of pain, and higher heart-rate variability after training. A secondary finding that can be obtained through the study is the comparison between the enhancement of heart rate variability in participants receiving different kinds of non-pharmacological therapies.
- Conditions
- Migraine Disorders
- Being tested
- cognitive behavioral therapy
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
cognitive behavioral therapy delivered by clinical psychologists in order to help patients gain coping skills.
| Study group | Role | What they receive |
|---|---|---|
| CBT group | Experimental | cognitive behavioral therapy (CBT)+routine medical care Receives: Behavioral: cognitive behavioral therapy |
| exercise therapy group | Experimental | physiotherapy-exercise therapy+routine medical care Receives: Behavioral: cognitive behavioral therapy |
| breathe training group | Experimental | using biofeedback devices to train breathing speed+routine medical care Receives: Behavioral: cognitive behavioral therapy |
| usual care | No intervention | accepting only routine medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of disability
Measured with the Migraine Disability Assessment Test (MIDAS). The total score ranges from 0 to 21 or more. Higher score indicates more disabilities related to migraine. Score over 21 indicates severe disability.
Measured: 8 weeks
severity of pain
Self-reported pain scores range from 0 to 10, with 0 meaning no pain at all, and 10 meaning extreme pain. Scoring over 7 indicates severe pain.
Measured: 8 weeks
Secondary outcomes (1)
heart rate variability
measured with wearable devices
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start16 Apr 2021
- Primary completion28 Feb 2024
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chung Shan Medical University
- Responsible party
- Sponsor
- Investigators
- Ling-Jun Liu, MSc, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743492
- Sponsor's protocol ID
- Y_109_0314
- Status last verified
- Sep 2023
- First submitted
- 3 Feb 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Pain Resilience Determines the Efficacy of Holistic Health Care of Patients With Migraine
- ClinicalTrials.gov ID
- NCT04743492
- Acronym / sponsor ID
- Y_109_0314
- Conditions
- Migraine Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Collaborators
- Chung Shan Medical University
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- May 2024 (estimated)
- First posted
- 8 Feb 2021 (actual)
- 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.
The purpose of this study is to investigate how pain resilience (as a personality characteristic or a strength) moderate the efficacy of treatment for patients with migraine.
The primary objective of the current study is to explore the moderation effect of pain resilience between initial pain and the treatment outcome of the holistic healthcare programs. The investigators hypothesize that participants with higher level of pain resilience will show more improvements in the quality of life, less disability (assessed with the Migraine Disability Assessment Test, MIDAS), less frequency and lower severity of pain, and higher heart-rate variability after training. A secondary finding that can be obtained through the study is the comparison between the enhancement of heart rate variability in participants receiving different kinds of non-pharmacological therapies.
Detailed description
Introduction：A multi-national research that included data from Taiwan found that chronic headache is one of the top two disorders (alongside with chronic low back pain) with the most patients having longest years of living with disabilities through year 1999 to 2017. It does not only impact a sufferer's ability to work, but also limit one's participation in a variety of daily housework, leisure activities, etc. Quality of life is also impacted. According to a systematic review on behavioral interventions for migraine, cognitive behavioral therapy (CBT) is one of the most common non-pharmacological practices implemented and studied. CBT has been found to be effective in reducing the intensity and frequency of headache, compared to waitlist controls. Another commonly discussed non-pharmacological treatment for migraine is exercise therapy.
In regard to the controversial findings from therapeutic clinical trials, the unsolved puzzle is: why do some show improvements while the others remained unchanged or worse? It is found that psychological resilience for pain can be a determining factor in task persistence despite the interruption of pain. Pain resilience specifically refers to the cognitive and behavioral aspects of an individual when one is trying to deal with pain. In a study investigating negative pain beliefs (i.e. fear avoidance and pain catastrophizing) and pain outcomes (functional and movement aspects), pain resilience was found to moderate the relationship between pain beliefs and pain outcomes. The authors found that only in individuals with low level of pain resilience was the negative pain beliefs related to greater movement-relate pain. Since pain resilience is such an important capacity/ dynamic process in coping with chronic pain, the current study aims at investigating how pain resilience can be a moderating factor determining the outcome of pain management in patients with migraine.
Objectives：The primary objective of the current study is to explore the moderation effect of pain resilience between initial pain and the treatment outcome of the holistic healthcare programs. The investigators hypothesize that participants with higher level of pain resilience will show more improvements in the quality of life, less disability (assessed with MIDAS), less frequency and lower severity of pain, and higher heart-rate variability after training. A secondary finding that can be obtained through the study is the comparison between the enhancement of heart rate variability in participants receiving different kinds of non-pharmacological therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CBT group | Experimental | Behavioral: cognitive behavioral therapycognitive behavioral therapy (CBT)+routine medical care |
| exercise therapy group | Experimental | Behavioral: cognitive behavioral therapyphysiotherapy-exercise therapy+routine medical care |
| breathe training group | Experimental | Behavioral: cognitive behavioral therapyusing biofeedback devices to train breathing speed+routine medical care |
| usual care | No intervention | –accepting only routine medical care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with migraine
Key exclusion criteria (5 listed)
- uncontrolled hypertension
- coronary artery disease
- arrhythmia
- secondary headache(except for medication overuse headache)a
- age under 20
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 behavioral therapycognitive behavioral therapy delivered by clinical psychologists in order to help patients gain coping skills. | Behavioural | CBT group, breathe training group, exercise therapy group |
Primary outcome
level of disability
Time frame: 8 weeks
Measured with the Migraine Disability Assessment Test (MIDAS). The total score ranges from 0 to 21 or more. Higher score indicates more disabilities related to migraine. Score over 21 indicates severe disability.
severity of pain
Time frame: 8 weeks
Self-reported pain scores range from 0 to 10, with 0 meaning no pain at all, and 10 meaning extreme pain. Scoring over 7 indicates severe pain.
1 secondary outcome
heart rate variability
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Ling-Jun Liu, MSc principal investigator
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy in people with Migraine Disorders, run by Changhua Christian 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 5 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 12 Mar 2024. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of disability (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 12 Mar 2024.