Mindfulness-Based Intervention for Adolescents With Chronic Migraine

Migraine Clinical Trial

Official title:

Mindfulness-Based Intervention for Adolescents With Chronic Migraine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06414109
• Other study ID #: 22-2359
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Michelle A Clementi, PhD
• Phone: 720-777-7487
• Email: michelle.clementi[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age 13 to 18 years

• Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition

• Patient report of >= 8 headache days per month

• PedMIDAS Score of > 10 (at least mild headache-related disability)

Exclusion Criteria:

• Weekly or bi-weekly therapy with a licensed behavioral health provider

• Major comorbid medical condition (e.g., cancer, epilepsy)

• Active psychosis or suicidal ideation

• Inability to provide consent/assent

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Migraine in Adolescence

Intervention

Behavioral:
• BREATHE-Migraine
The BREATHE-Migraine intervention was adapted from the research-supported curriculum, "Learning to BREATHE" (Broderick, 2021), based on qualitative feedback from adolescents with migraine, their parents, and pediatric headache providers. BREATHE-Migraine includes experiential and didactic exercises designed to address emotion regulation and the stress of living with frequent migraine.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention feasibility	Percent of sessions attended; Qualitative data generated via focus group interviews (questions will include barriers and facilitators to completing the intervention)	Up to 6 weeks
Primary	Intervention acceptability	Ratings on program acceptability questionnaire (higher scores indicate higher acceptability); Qualitative data generated via focus group interviews (questions will include positive and negative perceptions of the intervention)	7 weeks
Secondary	Change in headache-related disability	The Pediatric Migraine Disability Assessment (PedMIDAS) is a 6-item self-report questionnaire measuring the extent to which headaches interfered with school attendance and functioning, home functioning, and social attendance and functioning. Adolescents will be asked to indicate the number of days in the past 3 months in which they were unable to attend or fully participate in a range of activities. Lower scores indicate less disability.	Baseline, 6 weeks
Secondary	Change in emotion regulation	The Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) is an 18-item self-report measure of various dimensions of emotion dysregulation. Items are rated on a 6-point Likert scale ranging from 1 (almost never) to 5 (almost always). The DERS-SF provides a total score and 6 subscale scores. Lower scores indicate better emotion regulation.	Baseline, 6 weeks