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| ID | Type | Description | Link |
|---|---|---|---|
| MP-2021C3-24936 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.
Migraine is the second most disabling disease in the world. Research has primarily focused on treating migraine in adults; however, approximately 10% of children and adolescents have migraine, suggesting that up to 7 million youth are impacted in the United States alone. Given that the majority of youth have migraine symptoms that persist into adulthood, there is a critical need to identify and improve access to the most effective preventive migraine treatments for this population as a means of reducing the long-term healthcare burden and functional impairment of this illness.
This comparative effectiveness study will test CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) to CBT alone.
Participants will be involved in the study for approximately 28 weeks, with the first 4 weeks being a baseline period and the next 8 weeks involving six telehealth CBT sessions for both study groups (CBT while taking a clinically-prescribed pill-based prevention therapy [amitriptyline] compared to CBT alone), and dose titration of clinically-prescribed medication (amitriptyline) for the CBT + clinically-prescribed, pill-based prevention therapy (amitriptyline) group. During the remaining 16 weeks the participants will maintain the dose of medication (in the CBT + clinically-prescribed, pill-based prevention therapy (amitriptyline) group) and attend "booster" CBT sessions held three times over 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) | Experimental | This intervention consists of Cognitive Behavioral (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements. This arm will also take a daily oral dose of Amitriptyline, which will be clinically prescribed and managed by the patient's headache provider. |
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| CBT alone | Experimental | This intervention arm consists of 6 Cognitive Behavioral Therapy (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT | Behavioral | During an 8-week active treatment, participants will receive 6 telehealth CBT sessions, followed by a maintenance phase (16 weeks) when participants will receive 3 "booster" CBT sessions. The sessions will be conducted by teletherapists from the Clinical Coordinating Center at Cincinnati Children's using a standardized treatment manual. A parent/legal guardian will be included in 2 sessions teaching ways to be active coaches, encouraging use of effective coping skills and refraining from reinforcement of maladaptive coping. Each session will be about 45 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of headache days | This outcome measures whether there is a 50% reduction in the number of headaches days based on a self reported daily headache diary, per 28-day period, between the two arms. | baseline to weeks 4-8 to weeks 20-24 (post treatment) |
| Reduction to a PedMIDAS score of 20 or less | The PedMIDAS scale which evaluates the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions are answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale is administered at baseline (covering the three months prior to enrollment) and at the endpoint visit (covering last three months of enrollment). This outcome measures whether there is a reduction in migraine related disability measured by the Pediatric Migraine Disability Scale (PedMIDAS) between the two arms. A reduction to a score of 20 or less, indicating mild impact of less is a meaningful outcome for patients and families and considered clinically significant. | baseline to weeks 20-24 (post treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in absolute reduction in severe headache days | This outcome measures whether there is an absolute reduction in the number of severe headache days based on a self-reported daily headache diary, per 28-day period, between the two arms. | baseline to weeks 20-24 (post treatment) |
| Change in absolute headache days |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Change in self-reported physical and psychosocial functioning (functional impact) | The functional disability inventory (FDI) scale evaluates self-reported difficulty in physical health and psychosocial functioning due to physical health. The FDI contains 15 items related to activity limitations that are rated on a 5-point scale (0-no trouble; 4-Impossible). Scores range from 0 to 60, with higher scores indicating greater disability. The total score will be used in this study. Questions are answered by the youth in consultation with their parents and reviewed by study staff. The FDI is administered at baseline (covering the three months prior to enrollment) and at the endpoint visit (covering last three months of enrollment). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LeighAnn Chamberlin, MEd | Contact | 513-636-9739 | leighann.chamberlin@cchmc.org | |
| Megan Pfeiffer | Contact | 513-636-1846 | megan.pfeiffer@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Scott Powers, PhD | Cincinnati Childrens Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Children's of Alabama | Recruiting | Birmingham | Alabama | 35233 | United States |
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Only the principal investigator will remain blinded to the randomization assignment. All other study staff including the project manager, assistant project manager, study statistician, site investigators and study staff, participants, and their parents will be aware of the treatment assignment.
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| Amitriptyline | Drug | During an 8-week active treatment, participants will begin taking a daily pill (amitriptyline) prescribed and managed clinically by the site headache provider. Amitriptyline will be taken once a day before bedtime. The weight based dosage will gradually be increased based on tolerability and a standardized titration protocol during the 8 week active treatment. The participant will remain on a maximum tolerated dose for the final 16 weeks (maintenance). |
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This outcome measures whether there is an absolute reduction in the number of headache days based on a self-reported daily headache diary, per 28-day period, between the two arms. |
| baseline to weeks 4-8 to weeks 20-24 (post treatment) |
| Change in absolute headache disability score on PedMIDAS | The PedMIDAS scale which evaluates the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions are answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale is administered at baseline (covering the three months prior to enrollment) and at the post treatment visit (covering last three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this study. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities. | baseline to weeks 20-24 (post treatment) |
| Safety and tolerability of treatments (CBT and Amitriptyline) | This outcome measures the safety and participant satisfaction of both treatment arms by examining the number of participants who complete the CBT sessions (both arms) and the number of participants who continue to take the Amitriptyline (CBT+pill group). | randomization to weeks 20-24 (post treatment) |
| baseline to weeks 20-24 (post treatment) |
| Exploratory: Change in self-reported quality of life | The Pediatric Quality of Life Inventory (PedsQL) is a measure that is commonly used for comprehensive assessment of the impact of chronic illness. The 23-item pediatric self- and parent-report scales are validated for ages 5-18 and include items covering the domains of Physical, Social, Emotional and School Functioning. A total score is calculated by transforming 0-4 scaled items to a 0-100 scale and computing an average. The total score will be used in this study. The PedsQL is administered at baseline (covering the three months prior to enrollment) and at the endpoint visit (covering last three months of enrollment). | baseline to weeks 20-24 (post treatment) |
| Exploratory: Impact of social determinants of health | This exploratory outcome examines the impact of participant demographics (e.g. sex, gender, race, ethnicity, household income, housing, food, and transportation security, zip code) on primary outcomes. | baseline |
| Phoenix Children's Hospital - Barrow Neurological Institute | Recruiting | Phoenix | Arizona | 85016-7710 | United States |
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| University of California San Francisco | Recruiting | San Francisco | California | 94115 | United States |
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| University of Colorado/Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
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| Nemours Children's Health System | Recruiting | Wilmington | Delaware | 19810 | United States |
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| Clinical Integrative Research Center of Atlanta, Inc | Recruiting | Atlanta | Georgia | 30328 | United States |
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| University of Louisville Health/Norton | Recruiting | Louisville | Kentucky | 40292 | United States |
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| Louisiana State Univ/Children's Hospital of New Orleans | Recruiting | New Orleans | Louisiana | 70118-5720 | United States |
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| Dent Neurological Institute | Recruiting | Amherst | New York | 14226 | United States |
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| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| Nationwide Childrens | Recruiting | Columbus | Ohio | 43205 | United States |
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| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| University of Tennessee Health Science Center/ LeBonheur Children's Hospital | Recruiting | Memphis | Tennessee | 38103 | United States |
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| Dell Children's Hospital-UT Health | Recruiting | Austin | Texas | 78712 | United States |
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| Marshall Health | Recruiting | Huntington | West Virginia | 25701 | United States |
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| ID | Term |
|---|---|
| D006261 | Headache |
| D020773 | Headache Disorders |
| D008881 | Migraine Disorders |
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D051270 | Headache Disorders, Primary |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000639 | Amitriptyline |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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