Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorUniversity of Colorado, Denver
About 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
BREATHE with Headache (BREATHE-HA)
BehavioralBREATHE-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 Education
BehavioralEnhanced 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: BREATHE with Headache (BREATHE-HA)Experimental treatment 1 intervention
Group B: Enhanced Standard-of-Care: Headache EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Feasibility (Primary)
≥ 80% of adolescents screened eligible will agree to participate
Time frame
24 monthsSecondary outcomes
1
Recruitment Feasibility (Secondary)
Recruit N=72; mean n=6 enrolled per month
Time frame
24 months2
Retention (Secondary)
≥ 80% retained at post-intervention follow-up and 12-week follow-up
Time frame
Post-intervention (1 week after final intervention session); 12-week follow-up3
Intervention Adherence (Secondary)
\>80% of adolescents will attend 5 out of 6 (80% dose) of the intervention sessions
Time frame
6 weeks4
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
Time frame
Post-intervention (1 week after final intervention session)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: