Headache, MigrainePhase 2NCT03472092
Mind and Body Approaches to Pain Reduction in Youth With Migraine
A Phase 2 study testing Cognitive Behavioral Therapy (CBT), Amitriptyline and Biofeedback-Assisted Relaxation Training (BART) in people with Headache, Migraine and Migraine, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The overarching objective of this protocol is to identify and understand the neural and pain processing mechanisms by which youth with migraine improve in response to preventive treatment. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Headache, Migraine, Migraine, Migraine Disorders
- What is being tested?
- Cognitive Behavioral Therapy (CBT), Amitriptyline and Biofeedback-Assisted Relaxation Training (BART)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 30 Jun 2025
- Phase
- Phase 2
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders, 3rd Edition (beta) (ICHD-3b) criteria
- Frequency: Headache frequency based upon prospective headache diary of 28 days must be ≥ 8 and ≤ 28
- PedMIDAS: PedMIDAS Disability Score > 10, indicating at least mild disruption in daily activities and < 140, indicating extreme disability that may require more comprehensive, multi-component therapy
- English speaking: able to complete interviews and questionnaires in English
Who cannot join
- Continuous migraine defined as an unrelenting headache for a 28 day period
- Weight less than 30 kg or greater than 120 kg, or weight/size incompatible with magnetic resonance imaging (MRI) scanner
- Must agree not to take non-specific acute medication, such as nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications, such as triptans, more than 6 times per month
- No current prophylactic anti-migraine medication within a period equivalent to < 5 half-lives of that medication before entering the screening phase, and agree to not begin a migraine prevention medication during the study period
- Current use of the following medications/products: opioids, antipsychotics, antimanics, barbiturates, benzodiazepines, muscle relaxants, sedatives, tramadol, nutraceuticals
- Known history of allergic reaction or anaphylaxis to amitriptyline
Show all 13Show fewer
- Abnormal findings on electrocardiogram (ECG) at baseline, particularly lengthening of the QT interval ≥ 450 msec
- Orthodontic braces, metallic or electronic implants, or other metal objects in the body which obscure or interfere with the MRI, or pose a risk from heating, movement, or malfunction in the MRI environment
- Claustrophobia
- Youth who are pregnant, or those who are sexually active and not using a medically accepted form of contraception (barrier or hormonal methods)
- Diagnosis of epilepsy or other neurological diseases
- Inability to learn how to swallow pills using behavioral techniques (if indicated)
- Present psychiatric disease as defined by the Diagnostic and Statistical Manual (DSM) IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, attention deficit hyperactivity disorder (ADHD), or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Distinct Mechanisms of Cognitive Behavioral Therapy Effects in Youth With Migraine & Dissecting Neural Mechanisms Supporting Mind and Body Approaches to Pain Reduction in Youth With Migraine
The overarching objective of this protocol is to identify and understand the neural and pain processing mechanisms by which youth with migraine improve in response to preventive treatment. The study design of this mechanistic investigation includes functional magnetic resonance imaging (fMRI), daily headache diaries, assessment of conditioned pain modulation via quantitative sensory testing, and validated psychometric assessments before and after the delivery of one of five treatments over an 8 week period [cognitive behavioral therapy (CBT), biofeedback-assisted relaxation training (BART) and cognitive reappraisal (CR) training, amitriptyline, and placebo]. We are examining both distinct and common pathways that may help explain the response to various preventive treatments, as well as potential predictors of outcome.
Read the detailed description
Pediatric migraine is a prevalent disorder that results in significant pain and disability for children and adolescents. Despite the prevalence and cost, commonly used pharmacologic treatments to treat pediatric migraine have limited evidence of efficacy over placebo in preventing migraine in youth. In our prior research, published in NEJM (Trial of Amitriptyline, Topiramate, and Placebo for Pediatric Migraine. N Engl J Med. 2017;376(2):115-124),we have shown in a large, national, multicenter trial that the most widely used conventional preventive medications, amitriptyline (AMI) and topiramate, are no more effective than placebo. Psychological therapies for pediatric headache (in particular, cognitive behavioral therapy [CBT]) result in better outcomes than control conditions by effectively reducing headache days and disability in children and adolescents with migraine. Our own work indicates that youth receiving combined CBT plus amitriptyline (AMI, the most widely used migraine prophylactic in youth) had greater reductions in headache days and disability than a group receiving education control plus AMI. Specifically, we found that CBT combined with AMI improved outcomes for about 2 out of 3 pediatric chronic migraineurs (ages 10-17). Reduction in headache days by ≥ 50% was seen within the first 8 weeks of this 5-month trial (Powers SW, Kashikar-Zuck SM, Allen JR, et al. Cognitive behavioral therapy plus amitriptyline for chronic migraine in children and adolescents: a randomized clinical trial. JAMA. 2013;310(24):2622-2630).
Despite this evidence of efficacy, the mechanisms supporting CBT for migraine remain poorly understood. This lack of mechanistic understanding leaves patients, providers, and payers reluctant to promote CBT as a primary treatment modality. Moreover, opportunities to optimize and individualize CBT remain unrealized because of limited basic understanding by which different components of CBT exert their effects. Little remains known about the specific brain mechanisms by which CBT reduces pain. Therefore, it is critical that we understand how and why CBT may improve headache outcomes in contrast to pill-taking treatments, specifically placebo. Brain imaging and quantitative sensory testing are novel tools to investigate possible mechanisms of CBT, placebo, and medication. In addition understanding the components of CBT and how they may work at the brain and pain processing levels is important. As such, two broad components of CBT represent clear targets for investigation: relaxation and cognitive reappraisal.
Evolving consensus in the pain community and at a national level suggests that examining biological mechanisms of how mind and body approaches lead to benefits for patients will advance care, improve outcomes, and legitimize non-pharmacological treatment for pediatric chronic pain. As such, this mechanistic/basic science study seeks to identify the neural mechanisms by which youth with migraine improve in response to preventive treatment. Pediatric medical and behavioral clinicians can use mechanistic insights from this study to provide patients and families with a stronger rationale for treatment, thereby decreasing stigma and increasing confidence in and commitment to the care plan.
- Conditions
- Headache, Migraine, Migraine, Migraine Disorders, Headache
- Being tested
- Cognitive Behavioral Therapy (CBT), Placebo, Amitriptyline, Biofeedback-Assisted Relaxation Training (BART), Cognitive Reappraisal Training (CR)
- Keywords
- headache, migraine, cognitive behavioral therapy, amitriptyline, functional magnetic resonance imaging, conditioned pain modulation, brain connectivity, pediatrics
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
Also called CBT, coping skills, mind body relaxation
This intervention will consist of 8 weekly sessions. The duration of each session is about 45 minutes and will be led by a psychologist/therapist using a manualized protocol. About half of the sessions will be conducted in person and the remaining sessions will be offered via telehealth (Skype or phone).
PlaceboDrug
Also called Placebo Oral Capsule
The placebo pill will be administered once a day at home for 8 weeks, to be taken by mouth with or without food under the supervision of the participant's parent or guardian. To maintain blinding, all participants will receive 1 matching capsule as a daily dose to be taken each evening during the study.
AmitriptylineDrug
Also called Elavil
Amitriptyline will be administered once a day at home for 8 weeks, to be taken by mouth with or without food under the supervision of the participant's parent or guardian. To maintain blinding, all participants will receive 1 matching capsule as a daily dose to be taken each evening during the study. For this study, a dose of 0.25 mg/kg/day will be provided for the 1st 2 weeks, followed by a dose of 0.5 mg/kg/day for 2 weeks, 0.75 mg/kg/day for 2 weeks and a maximum dose of 1.0 mg/kg/day for 2 weeks based on tolerability. Participants experiencing tolerability issues, may be held a current dose rather than titrated to the next dosage if deemed appropriate by the study doctor.
Biofeedback-Assisted Relaxation Training (BART)Behavioural
This intervention will consist of 8 weekly sessions. The duration of each session is about 45 minutes and will be led by a psychologist/therapist using a manualized protocol. About half of the sessions will be conducted in person and the remaining sessions will be offered via telehealth (Skype or phone).
Cognitive Reappraisal Training (CR)Behavioural
This intervention will consist of 8 weekly sessions. The duration of each session is about 45 minutes and will be led by a psychologist/therapist using a manualized protocol. About half of the sessions will be conducted in person and the remaining sessions will be offered via telehealth (Skype or phone).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Cognitive Behavioral Therapy (CBT) is a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| Placebo | Placebo comparator | The placebo pill will be administered once a day at home, to be taken by mouth. Receives: Drug: Placebo |
| Amitriptyline | Active comparator | Amitriptyline will be administered once a day at home, to be taken by mouth. Dosage will be weight-based. Receives: Drug: Amitriptyline |
| Biofeedback-Assisted Relaxation Training (BART) | Active comparator | Biofeedback-Assisted Relaxation Training (BART) is a mind and body based intervention that focuses specifically on mind and body techniques such as deep breathing, muscle relaxation, and guided imagery skills to manage pain. Receives: Behavioral: Biofeedback-Assisted Relaxation Training (BART) |
| Cognitive Retraining (CR) | Active comparator | Cognitive Retraining (CR) is a mind and body based intervention that focuses on the use of tests of evidence and other cognitive strategies such as positive coping statements and pleasant activities and mindfulness to manage pain. Receives: Behavioral: Cognitive Reappraisal Training (CR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional resonance imaging (fMRI)
For each study group, changes in distinct neural mechanisms of the brain will be compared to between baseline and post treatment (8 weeks). For each study group, the primary endpoint will be examine changes in brain connectivity and activation.
Measured: baseline and post treatment (8 weeks post randomization)
Conditioned pain modulation as measured in a standard protocol using quantitative sensory testing. Employed as a predictor of headache day change in the study analytic plan
Conditioned pain modulation as measured by quantitative sensory testing will be established for each participant. This measure involves testing pain tolerance of pressure and cold pain stimuli in a controlled manner using a standard protocol. Baseline levels of CPM for each study group will be used to predict headache day reduction for each study group. The hypothesis to be tested is that low efficiency of CPM will be differentially predictive of headache reductions following CBT in relation to other study groups.
Measured: baseline and post treatment (8 weeks post randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start2 Oct 2018
- Primary completion24 Feb 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mechanistic/basic science project seeking to identify the neural mechanisms by which youth with migraine improve in response to preventive treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Scott Powers, PhD, Principal investigator, Children's Hospital Medical Center, CincinnatiRobert Coghill, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472092
- Sponsor's protocol ID
- CAP Imaging Study I-II
- Other IDs
- R01NS101321, R01AT010171
- Status last verified
- Aug 2025
- First submitted
- 14 Mar 2018
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distinct Mechanisms of Cognitive Behavioral Therapy Effects in Youth With Migraine & Dissecting Neural Mechanisms Supporting Mind and Body Approaches to Pain Reduction in Youth With Migraine
- ClinicalTrials.gov ID
- NCT03472092
- Acronym / sponsor ID
- CAP Imaging Study I-II
- Conditions
- Headache, Migraine, Migraine, Migraine Disorders, Headache
- Keywords
- headache, migraine, cognitive behavioral therapy, amitriptyline, functional magnetic resonance imaging, conditioned pain modulation, brain connectivity, pediatrics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 21 Mar 2018 (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 overarching objective of this protocol is to identify and understand the neural and pain processing mechanisms by which youth with migraine improve in response to preventive treatment. The study design of this mechanistic investigation includes functional magnetic resonance imaging (fMRI), daily headache diaries, assessment of conditioned pain modulation via quantitative sensory testing, and validated psychometric assessments before and after the delivery of one of five treatments over an 8 week period [cognitive behavioral therapy (CBT), biofeedback-assisted relaxation training (BART) and cognitive reappraisal (CR) training, amitriptyline, and placebo]. We are examining both distinct and common pathways that may help explain the response to various preventive treatments, as well as potential predictors of outcome.
Detailed description
Pediatric migraine is a prevalent disorder that results in significant pain and disability for children and adolescents. Despite the prevalence and cost, commonly used pharmacologic treatments to treat pediatric migraine have limited evidence of efficacy over placebo in preventing migraine in youth. In our prior research, published in NEJM (Trial of Amitriptyline, Topiramate, and Placebo for Pediatric Migraine. N Engl J Med. 2017;376(2):115-124),we have shown in a large, national, multicenter trial that the most widely used conventional preventive medications, amitriptyline (AMI) and topiramate, are no more effective than placebo. Psychological therapies for pediatric headache (in particular, cognitive behavioral therapy [CBT]) result in better outcomes than control conditions by effectively reducing headache days and disability in children and adolescents with migraine. Our own work indicates that youth receiving combined CBT plus amitriptyline (AMI, the most widely used migraine prophylactic in youth) had greater reductions in headache days and disability than a group receiving education control plus AMI. Specifically, we found that CBT combined with AMI improved outcomes for about 2 out of 3 pediatric chronic migraineurs (ages 10-17). Reduction in headache days by ≥ 50% was seen within the first 8 weeks of this 5-month trial (Powers SW, Kashikar-Zuck SM, Allen JR, et al. Cognitive behavioral therapy plus amitriptyline for chronic migraine in children and adolescents: a randomized clinical trial. JAMA. 2013;310(24):2622-2630).
Despite this evidence of efficacy, the mechanisms supporting CBT for migraine remain poorly understood. This lack of mechanistic understanding leaves patients, providers, and payers reluctant to promote CBT as a primary treatment modality. Moreover, opportunities to optimize and individualize CBT remain unrealized because of limited basic understanding by which different components of CBT exert their effects. Little remains known about the specific brain mechanisms by which CBT reduces pain. Therefore, it is critical that we understand how and why CBT may improve headache outcomes in contrast to pill-taking treatments, specifically placebo. Brain imaging and quantitative sensory testing are novel tools to investigate possible mechanisms of CBT, placebo, and medication. In addition understanding the components of CBT and how they may work at the brain and pain processing levels is important. As such, two broad components of CBT represent clear targets for investigation: relaxation and cognitive reappraisal.
Evolving consensus in the pain community and at a national level suggests that examining biological mechanisms of how mind and body approaches lead to benefits for patients will advance care, improve outcomes, and legitimize non-pharmacological treatment for pediatric chronic pain. As such, this mechanistic/basic science study seeks to identify the neural mechanisms by which youth with migraine improve in response to preventive treatment. Pediatric medical and behavioral clinicians can use mechanistic insights from this study to provide patients and families with a stronger rationale for treatment, thereby decreasing stigma and increasing confidence in and commitment to the care plan.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Mechanistic/basic science project seeking to identify the neural mechanisms by which youth with migraine improve in response to preventive treatment.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT)Cognitive Behavioral Therapy (CBT) is a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements. |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo pill will be administered once a day at home, to be taken by mouth. |
| Amitriptyline | Active comparator | Drug: AmitriptylineAmitriptyline will be administered once a day at home, to be taken by mouth. Dosage will be weight-based. |
| Biofeedback-Assisted Relaxation Training (BART) | Active comparator | Behavioral: Biofeedback-Assisted Relaxation Training (BART)Biofeedback-Assisted Relaxation Training (BART) is a mind and body based intervention that focuses specifically on mind and body techniques such as deep breathing, muscle relaxation, and guided imagery skills to manage pain. |
| Cognitive Retraining (CR) | Active comparator | Behavioral: Cognitive Reappraisal Training (CR)Cognitive Retraining (CR) is a mind and body based intervention that focuses on the use of tests of evidence and other cognitive strategies such as positive coping statements and pleasant activities and mindfulness to manage pain. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders, 3rd Edition (beta) (ICHD-3b) criteria
- Frequency: Headache frequency based upon prospective headache diary of 28 days must be ≥ 8 and ≤ 28
- PedMIDAS: PedMIDAS Disability Score > 10, indicating at least mild disruption in daily activities and < 140, indicating extreme disability that may require more comprehensive, multi-component therapy
- English speaking: able to complete interviews and questionnaires in English
Key exclusion criteria (13 listed)
- Continuous migraine defined as an unrelenting headache for a 28 day period
- Weight less than 30 kg or greater than 120 kg, or weight/size incompatible with magnetic resonance imaging (MRI) scanner
- Must agree not to take non-specific acute medication, such as nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications, such as triptans, more than 6 times per month
- No current prophylactic anti-migraine medication within a period equivalent to < 5 half-lives of that medication before entering the screening phase, and agree to not begin a migraine prevention medication during the study period
- Current use of the following medications/products: opioids, antipsychotics, antimanics, barbiturates, benzodiazepines, muscle relaxants, sedatives, tramadol, nutraceuticals
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 Therapy (CBT)Also: CBT, coping skills, mind body relaxationThis intervention will consist of 8 weekly sessions. The duration of each session is about 45 minutes and will be led by a psychologist/therapist using a manualized protocol. About half of the sessions will be conducted in person and the remaining sessions will be offered via telehealth (Skype or phone). | Behavioural | Cognitive Behavioral Therapy (CBT) |
| PlaceboAlso: Placebo Oral CapsuleThe placebo pill will be administered once a day at home for 8 weeks, to be taken by mouth with or without food under the supervision of the participant's parent or guardian. To maintain blinding, all participants will receive 1 matching capsule as a daily dose to be taken each evening during the study. | Drug | Placebo |
| AmitriptylineAlso: ElavilAmitriptyline will be administered once a day at home for 8 weeks, to be taken by mouth with or without food under the supervision of the participant's parent or guardian. To maintain blinding, all participants will receive 1 matching capsule as a daily dose to be taken each evening during the study. For this study, a dose of 0.25 mg/kg/day will be provided for the 1st 2 weeks, followed by a dose of 0.5 mg/kg/day for 2 weeks, 0.75 mg/kg/day for 2 weeks and a maximum dose of 1.0 mg/kg/day for 2 weeks based on tolerability. Participants experiencing tolerability issues, may be held a current dose rather than titrated to the next dosage if deemed appropriate by the study doctor. | Drug | Amitriptyline |
| Biofeedback-Assisted Relaxation Training (BART)This intervention will consist of 8 weekly sessions. The duration of each session is about 45 minutes and will be led by a psychologist/therapist using a manualized protocol. About half of the sessions will be conducted in person and the remaining sessions will be offered via telehealth (Skype or phone). | Behavioural | Biofeedback-Assisted Relaxation Training (BART) |
| Cognitive Reappraisal Training (CR)This intervention will consist of 8 weekly sessions. The duration of each session is about 45 minutes and will be led by a psychologist/therapist using a manualized protocol. About half of the sessions will be conducted in person and the remaining sessions will be offered via telehealth (Skype or phone). | Behavioural | Cognitive Retraining (CR) |
Primary outcome
Change in functional resonance imaging (fMRI)
Time frame: baseline and post treatment (8 weeks post randomization)
For each study group, changes in distinct neural mechanisms of the brain will be compared to between baseline and post treatment (8 weeks). For each study group, the primary endpoint will be examine changes in brain connectivity and activation.
Conditioned pain modulation as measured in a standard protocol using quantitative sensory testing. Employed as a predictor of headache day change in the study analytic plan
Time frame: baseline and post treatment (8 weeks post randomization)
Conditioned pain modulation as measured by quantitative sensory testing will be established for each participant. This measure involves testing pain tolerance of pressure and cold pain stimuli in a controlled manner using a standard protocol. Baseline levels of CPM for each study group will be used to predict headache day reduction for each study group. The hypothesis to be tested is that low efficiency of CPM will be differentially predictive of headache reductions following CBT in relation to other study groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- 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.
Scott Powers, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
Robert Coghill, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive Behavioral Therapy (CBT), Amitriptyline and Biofeedback-Assisted Relaxation Training (BART) in people with Headache, Migraine and Migraine, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 26 Aug 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in functional resonance imaging (fMRI) (time frame: baseline and post treatment (8 weeks post randomization)). 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 26 Aug 2025.