MigraineHEADS-UPNCT07513662
Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
A study testing BREATHE with Headache (BREATHE-HA) and Enhanced Standard-of-Care: Headache Education in people with Migraine and Migraine in Adolescence, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Migraine, Migraine in Adolescence
- What is being tested?
- BREATHE with Headache (BREATHE-HA) and Enhanced Standard-of-Care: Headache Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 12 to 17 years old
- Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition
- Patient report of at least 6 headache days per month
- At least mild headache-related disability, as assessed by PedMIDAS score > 10
- Stable dose (≥4 weeks) of prophylactic migraine medication or no current prophylactic medication at enrollment
- Adolescent participant fluent in English for the intervention content
Who cannot join
- Currently engaged in, or previously received 4 or more sessions of behavioral interventions for pain management (e.g., mindfulness or cognitive-behavioral therapy) in the past 6 months
- Current psychiatric crisis (e.g., active suicidal ideation)
- Cognitive impairments or developmental delays that interfere with their ability to participate in the study
- Inability to provide consent/assent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arlet Campuzano, B.S. contact
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Michelle A Clementi, Ph.D., 720-777-7487, michelle.clementi@childrenscolorado.org
Arlet Campuzano, B.S., 720-777-4904, arlet.campuzano@childrenscolorado.org
About this study
Official title: Feasibility Trial of a Remotely-Delivered Mindfulness-Based Intervention for Adolescents With Migraine
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:
- Telehealth group mindfulness-based intervention
- Telehealth group headache education
Read the 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 examining an MBI that was adapted specifically for adolescents with migraine. This a pilot randomized controlled trial is designed to test feasibility and acceptability in preparation for a future efficacy trial. Adolescents with migraine will be randomized to one of two 6-week telehealth group programs: a mindfulness-based intervention (BREATHE-Headache) or Enhanced Standard-of-Care (a headache education program). Participants (and their parent/guardian) will complete assessments at baseline, immediately post-intervention, and 12-week follow up.
- Conditions
- Migraine, Migraine in Adolescence
- Being tested
- BREATHE with Headache (BREATHE-HA), Enhanced Standard-of-Care: Headache Education
- Keywords
- Adolescent, Mindfulness, Mindfulness Intervention, Migraine, Headache, Headache Education, Randomized controlled trial
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREATHE with Headache (BREATHE-HA)Behavioural
BREATHE-HA is a 6-session group mindfulness-based intervention delivered via telehealth for adolescents with migraine. The intervention was adapted from an empirically-supported mindfulness-based intervention for adolescents (Learning to BREATHE; Broderick, 2021). Example activities include breath awareness, body scanning, mindful eating, loving-kindness practice, and mindful movement, as well as activities and discussion focused on improving distress tolerance and enhancing self-care, with examples related to living with migraine.
Enhanced Standard-of-Care: Headache EducationBehavioural
Enhanced Standard-of-Care is a 6-session group headache education program delivered via telehealth. It will be derived from a manual with fidelity as an attention-matched control in a behavioral trial for pediatric migraine. Headache education will include didactics and discussion on headache symptoms, medication, lifestyle factors for pain management, communication with providers, education on mood/stress, and impact of headaches on school and family.
| Study group | Role | What they receive |
|---|---|---|
| BREATHE with Headache (BREATHE-HA) | Experimental | Mindfulness-based intervention adapted for adolescents with migraine, delivered as a telehealth group program Receives: Behavioral: BREATHE with Headache (BREATHE-HA) |
| Enhanced Standard-of-Care: Headache Education | Active comparator | Headache education, delivered as a telehealth group program Receives: Behavioral: Enhanced Standard-of-Care: Headache Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility (Primary)
≥ 80% of adolescents screened eligible will agree to participate
Measured: 24 months
Secondary outcomes (6)
Recruitment Feasibility (Secondary)
Recruit N=72; mean n=6 enrolled per month
Measured: 24 months
Retention (Secondary)
≥ 80% retained at post-intervention follow-up and 12-week follow-up
Measured: Post-intervention (1 week after final intervention session); 12-week follow-up
Intervention Adherence (Secondary)
>80% of adolescents will attend 5 out of 6 (80% dose) of the intervention sessions
Measured: 6 weeks
Acceptability (Secondary)
≥80% adolescent liking/credibility ratings ≥4 (1=not at all to 5=extremely) on the adapted Program Acceptability Questionnaire; qualitative themes indicative of liking/credibility, as derived from grounded theory/qualitative analysis of adolescent focus groups at post-intervention
Measured: Post-intervention (1 week after final intervention session)
Protocol Feasibility (Secondary)
≤10% missing daily log data and 0% missing entire questionnaires at all time points
Measured: Baseline, post-intervention (1 week after final intervention session), 12-week follow-up
Intervention Fidelity (Secondary)
>95% interventionist adherence to content delivery based on fidelity checklists
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start10 Nov 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Michelle A Clementi, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513662
- Sponsor's protocol ID
- 25-1999
- Other IDs
- 1K23AT013838
- Acronym
- HEADS-UP
- Status last verified
- Nov 2026
- First submitted
- 19 Mar 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Broderick, P. C. (2021). Learning to breathe: A mindfulness curriculum for adolescents to cultivate emotion regulation, attention, and performance. New Harbinger Publications.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of a Remotely-Delivered Mindfulness-Based Intervention for Adolescents With Migraine
- ClinicalTrials.gov ID
- NCT07513662
- Acronym / sponsor ID
- HEADS-UP / 25-1999
- Conditions
- Migraine, Migraine in Adolescence
- Keywords
- Adolescent, Mindfulness, Mindfulness Intervention, Migraine, Headache, Headache Education, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Telehealth group mindfulness-based intervention
- Telehealth group headache education
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 examining an MBI that was adapted specifically for adolescents with migraine. This a pilot randomized controlled trial is designed to test feasibility and acceptability in preparation for a future efficacy trial. Adolescents with migraine will be randomized to one of two 6-week telehealth group programs: a mindfulness-based intervention (BREATHE-Headache) or Enhanced Standard-of-Care (a headache education program). Participants (and their parent/guardian) will complete assessments at baseline, immediately post-intervention, and 12-week follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BREATHE with Headache (BREATHE-HA) | Experimental | Behavioral: BREATHE with Headache (BREATHE-HA)Mindfulness-based intervention adapted for adolescents with migraine, delivered as a telehealth group program |
| Enhanced Standard-of-Care: Headache Education | Active comparator | Behavioral: Enhanced Standard-of-Care: Headache EducationHeadache education, delivered as a telehealth group program |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 12 to 17 years old
- Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition
- Patient report of at least 6 headache days per month
- At least mild headache-related disability, as assessed by PedMIDAS score > 10
- Stable dose (≥4 weeks) of prophylactic migraine medication or no current prophylactic medication at enrollment
Key exclusion criteria (4 listed)
- Currently engaged in, or previously received 4 or more sessions of behavioral interventions for pain management (e.g., mindfulness or cognitive-behavioral therapy) in the past 6 months
- Current psychiatric crisis (e.g., active suicidal ideation)
- Cognitive impairments or developmental delays that interfere with their ability to participate in the study
- Inability to provide consent/assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BREATHE with Headache (BREATHE-HA)BREATHE-HA is a 6-session group mindfulness-based intervention delivered via telehealth for adolescents with migraine. The intervention was adapted from an empirically-supported mindfulness-based intervention for adolescents (Learning to BREATHE; Broderick, 2021). Example activities include breath awareness, body scanning, mindful eating, loving-kindness practice, and mindful movement, as well as activities and discussion focused on improving distress tolerance and enhancing self-care, with examples related to living with migraine. | Behavioural | BREATHE with Headache (BREATHE-HA) |
| Enhanced Standard-of-Care: Headache EducationEnhanced Standard-of-Care is a 6-session group headache education program delivered via telehealth. It will be derived from a manual with fidelity as an attention-matched control in a behavioral trial for pediatric migraine. Headache education will include didactics and discussion on headache symptoms, medication, lifestyle factors for pain management, communication with providers, education on mood/stress, and impact of headaches on school and family. | Behavioural | Enhanced Standard-of-Care: Headache Education |
Primary outcome
Recruitment Feasibility (Primary)
Time frame: 24 months
≥ 80% of adolescents screened eligible will agree to participate
6 secondary outcomes
Recruitment Feasibility (Secondary)
Time frame: 24 months
Retention (Secondary)
Time frame: Post-intervention (1 week after final intervention session); 12-week follow-up
Intervention Adherence (Secondary)
Time frame: 6 weeks
Acceptability (Secondary)
Time frame: Post-intervention (1 week after final intervention session)
Protocol Feasibility (Secondary)
Time frame: Baseline, post-intervention (1 week after final intervention session), 12-week follow-up
Intervention Fidelity (Secondary)
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- BackgroundBroderick, P. C. (2021). Learning to breathe: A mindfulness curriculum for adolescents to cultivate emotion regulation, attention, and performance. New Harbinger Publications.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arlet Campuzano, B.S. contact
Michelle A Clementi, Ph.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BREATHE with Headache (BREATHE-HA) and Enhanced Standard-of-Care: Headache Education in people with Migraine and Migraine in Adolescence, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle A Clementi, Ph.D. (720-777-7487, michelle.clementi@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (Primary) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07513662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.