Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03472092
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2018-03-14
Brief Title:
Mind and Body Approaches to Pain Reduction in Youth With Migraine
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
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:
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 20173762115-124we 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 2013310242622-2630
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 mechanisticbasic 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
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 mechanisticbasic 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS101321 | NIH | None | None |
| R01AT010171 | NIH | None | httpsreporternihgovquickSearchR01AT010171 |