An interventional study of CBT and Amitriptyline in Headache, Headache Disorders and Headache, Migraine, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 15 sites in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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.
762 studies on the registry are indexed under Headache; 134 are open to participants now.
This study's planned enrollment of 400 is above the median of 65 across 560 interventional studies indexed under Headache.
Browse Headache studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: CBT · Drug: Amitriptyline
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.
Behavioral: CBT
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.
Also known as: Cognitive Behavioral Therapy
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).
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.
Time frame: 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.
Time frame: baseline to weeks 20-24 (post treatment)
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.
Time frame: baseline to weeks 20-24 (post treatment)
Change in absolute headache days
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.
Time frame: 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.
Time frame: 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).
Time frame: randomization to weeks 20-24 (post treatment)
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).
Time frame: 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).
Time frame: 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.
Time frame: baseline
Started Aug 2023 (actual). Primary completion is estimated for Jul 2027, 47 months after the start.
Of 175 non-industry interventional studies with no phase under Headache, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 37. This study's planned 47 months is above that.
Counting every sponsor, half of 193 studies reached it within 14 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Amitriptyline
Children's Hospital Medical Center, Cincinnati →