Mindfulness vs Education for Migraine

(HEADS-UP Trial)

MA
MT
Overseen ByMichelle T Harmon, B.S.
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study (supported by and included in the NIH HEAL Initiative: https://heal.nih.gov/) is to learn if a fully virtual study comparing two telehealth group interventions for adolescents with migraine is feasible and acceptable:

1. Telehealth group mindfulness-based intervention

2. Telehealth group headache education

Who Is on the Research Team?

MA

Michelle A Clementi, Ph.D.

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

Inclusion Criteria

I have headaches at least 6 days each month.
I am between 12 and 17 years old.
I have been diagnosed with migraine by my doctor.
See 3 more

Exclusion Criteria

I have had at least 4 sessions of pain management therapy in the past 6 months.
Current psychiatric crisis (e.g., active suicidal ideation)
I do not have cognitive or developmental issues that prevent me from joining the study.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to a 6-week telehealth group program: either a mindfulness-based intervention or headache education

6 weeks
6 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
1 virtual visit post-intervention, 1 virtual visit at 12-week follow-up

What Are the Treatments Tested in This Trial?

Interventions

  • BREATHE with Headache (BREATHE-HA)
  • Enhanced Standard-of-Care: Headache Education

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: BREATHE with Headache (BREATHE-HA)Experimental Treatment1 Intervention
Group II: Enhanced Standard-of-Care: Headache EducationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+