MigraineNCT06414109
Mindfulness-Based Intervention for Adolescents With Chronic Migraine
A study testing BREATHE-Migraine 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 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Migraine, Migraine in Adolescence
- What is being tested?
- BREATHE-Migraine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2024to 23 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Major comorbid medical condition (e.g., cancer, epilepsy)
- Active psychosis or suicidal ideation
- Inability to provide consent/assent
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
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.
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 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.
- Conditions
- Migraine, Migraine in Adolescence
- Being tested
- BREATHE-Migraine
- Keywords
- Adolescent, Mindfulness, Mindfulness Intervention, Migraine, Headache
- 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-MigraineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BREATHE-Migraine | Experimental | Participants will receive 6 weekly 1-hour sessions of a remotely-delivered mindfulness-based intervention in a group setting. Receives: Behavioral: BREATHE-Migraine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention feasibility
Percent of sessions attended; Qualitative data generated via focus group interviews (questions will include barriers and facilitators to completing the intervention)
Measured: Up to 6 weeks
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)
Measured: 7 weeks
Secondary outcomes (2)
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.
Measured: Baseline, 6 weeks
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.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start4 Jun 2024
- Primary completion23 May 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Michelle A Clementi, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414109
- Sponsor's protocol ID
- 22-2359
- Status last verified
- Jul 2025
- First submitted
- 10 May 2024
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Intervention for Adolescents With Chronic Migraine
- ClinicalTrials.gov ID
- NCT06414109
- Acronym / sponsor ID
- 22-2359
- Conditions
- Migraine, Migraine in Adolescence
- Keywords
- Adolescent, Mindfulness, Mindfulness Intervention, Migraine, Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 16 May 2024 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BREATHE-Migraine | Experimental | Behavioral: BREATHE-MigraineParticipants will receive 6 weekly 1-hour sessions of a remotely-delivered mindfulness-based intervention in a group setting. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Major comorbid medical condition (e.g., cancer, epilepsy)
- Active psychosis or suicidal ideation
- 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-MigraineThe 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. | Behavioural | BREATHE-Migraine |
Primary outcome
Intervention feasibility
Time frame: Up to 6 weeks
Percent of sessions attended; Qualitative data generated via focus group interviews (questions will include barriers and facilitators to completing the intervention)
Intervention acceptability
Time frame: 7 weeks
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)
2 secondary outcomes
Change in headache-related disability
Time frame: Baseline, 6 weeks
Change in emotion regulation
Time frame: Baseline, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
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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. This study is not recruiting at the moment.
Michelle A Clementi, PhD 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-Migraine 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 4 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention feasibility (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jul 2025.