Mind and Body Approaches to Pain Reduction in Youth With Migraine
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
3 other identifiers
interventional
132
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2018
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2018
CompletedFirst Posted
Study publicly available on registry
March 21, 2018
CompletedStudy Start
First participant enrolled
October 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedAugust 26, 2025
August 1, 2025
6.4 years
March 14, 2018
August 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
baseline and post treatment (8 weeks post randomization)
Study Arms (5)
Cognitive Behavioral Therapy (CBT)
EXPERIMENTALCognitive 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 COMPARATORThe placebo pill will be administered once a day at home, to be taken by mouth.
Amitriptyline
ACTIVE COMPARATORAmitriptyline will be administered once a day at home, to be taken by mouth. Dosage will be weight-based.
Biofeedback-Assisted Relaxation Training (BART)
ACTIVE COMPARATORBiofeedback-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 COMPARATORCognitive 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.
Interventions
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).
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.
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.
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).
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Powers, PhD
Children's Hospital Medical Center, Cincinnati
- PRINCIPAL INVESTIGATOR
Robert Coghill, PhD
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Behavioral therapy assignment is known to the treating therapist/care provider. Placebo and amitriptyline are double blinded. Participant will be aware they are either assigned to behavioral or pill therapy.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2018
First Posted
March 21, 2018
Study Start
October 2, 2018
Primary Completion
February 24, 2025
Study Completion
June 30, 2025
Last Updated
August 26, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share