Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414109
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-10
Brief Title:
Mindfulness-Based Intervention for Adolescents With Chronic Migraine
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Mindfulness-Based Intervention for Adolescents With Chronic Migraine
Status:
RECRUITING
Status Verified Date:
2024-07
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 goal of this study is to assess feasibility and acceptability of a mindfulness-based intervention adapted for adolescents with migraine to inform a future randomized trial assessing effects of the intervention on headache-related outcomes
Detailed Description:
Mindfulness-based intervention MBI shows promise in adults with migraine but research is limited in adolescents The current study aims to advance behavioral treatments for adolescents with frequent migraine by adapting an existing empirically-supported MBI for adolescents Learning to BREATHE to meet the unique needs of adolescents with chronic migraine In Phase I of the study we will use feedback solicited from interviews with teens with chronic migraine their parents and healthcare providers documenting the experience of living with chronic migraine and on the content and delivery of the MBI to create an adapted telehealth group intervention specifically tailored for adolescents with frequent migraine In Phase II of the study the adapted MBI will be piloted in a single-arm trial with adolescents with frequent migraine to assess feasibility acceptability and preliminary clinical signals
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