Educação e Consciencialização sobre Cefaleias vs. Estratégias Diárias de Mindfulness - Compreensão da Dor (HEADS-UP)
Estudo de Viabilidade de uma Intervenção Baseada em Mindfulness Remotamente Administrada para Adolescentes com Enxaqueca
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
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Michelle A Clementi, Ph.D.
- Número de telefone: 720-777-7487
- E-mail: michelle.clementi@childrenscolorado.org
Estude backup de contato
- Nome: Arlet Campuzano, B.S.
- E-mail: arlet.campuzano@childrenscolorado.org
Locais de estudo
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Recrutamento
- Children's Hospital Colorado
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Contato:
- Michelle A Clementi, Ph.D.
- Número de telefone: 720-777-7487
- E-mail: michelle.clementi@childrenscolorado.org
-
Contato:
- Arlet Campuzano, B.S.
- Número de telefone: 720-777-4904
- E-mail: arlet.campuzano@childrenscolorado.org
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: BREATHE with Headache (BREATHE-HA)
Mindfulness-based intervention adapted for adolescents with migraine, delivered as a telehealth group program |
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. |
|
Comparador Ativo: Enhanced Standard-of-Care: Headache Education
Headache education, delivered as a telehealth group program |
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment Feasibility (Primary)
Prazo: 24 months
|
≥ 80% of adolescents screened eligible will agree to participate |
24 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment Feasibility (Secondary)
Prazo: 24 months
|
Recruit N=72; mean n=6 enrolled per month |
24 months
|
|
Retention (Secondary)
Prazo: Post-intervention (1 week after final intervention session); 12-week follow-up
|
≥ 80% retained at post-intervention follow-up and 12-week follow-up |
Post-intervention (1 week after final intervention session); 12-week follow-up
|
|
Intervention Adherence (Secondary)
Prazo: 6 weeks
|
>80% of adolescents will attend 5 out of 6 (80% dose) of the intervention sessions |
6 weeks
|
|
Acceptability (Secondary)
Prazo: Post-intervention (1 week after final intervention session)
|
≥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)
Prazo: Baseline, post-intervention (1 week after final intervention session), 12-week follow-up
|
≤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)
Prazo: 6 weeks
|
>95% interventionist adherence to content delivery based on fidelity checklists |
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michelle A Clementi, Ph.D., University of Colorado, Denver
Publicações e links úteis
Publicações Gerais
- Broderick, P. C. (2021). Learning to breathe: A mindfulness curriculum for adolescents to cultivate emotion regulation, attention, and performance. New Harbinger Publications.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 25-1999
- 1K23AT013838 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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