Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05889624
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2023-05-10
Brief Title:
Responding With Evidence and Access for Childhood Headaches
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Cognitive Behavioral Therapy Via Telehealth Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth Pediatric Migraine Prevention Responding With Evidence and Access for Childhood Headaches
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MP-2021C3-24936 | OTHER_GRANT | PCORI | None |