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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AT013838 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BREATHE with Headache (BREATHE-HA) | Experimental | Mindfulness-based intervention adapted for adolescents with migraine, delivered as a telehealth group program |
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| Enhanced Standard-of-Care: Headache Education | Active Comparator | Headache education, delivered as a telehealth group program |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BREATHE with Headache (BREATHE-HA) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility (Primary) | ≥ 80% of adolescents screened eligible will agree to participate | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility (Secondary) | Recruit N=72; mean n=6 enrolled per month | 24 months |
| Retention (Secondary) | ≥ 80% retained at post-intervention follow-up and 12-week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle A Clementi, Ph.D. | Contact | 720-777-7487 | michelle.clementi@childrenscolorado.org | |
| Michelle T Harmon, B.S. | Contact | 720-777-4904 | michelle.harmon@childrenscolorado.org |
| Name | Affiliation | Role |
|---|---|---|
| Michelle A Clementi, Ph.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Broderick, P. C. (2021). Learning to breathe: A mindfulness curriculum for adolescents to cultivate emotion regulation, attention, and performance. New Harbinger Publications. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Enhanced Standard-of-Care: Headache Education | Behavioral | 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. |
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| 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 | 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 | 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 | 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 | 6 weeks |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |