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Completed
NCT06440876
Music and Imagery for Veterans With Migraine Headache
Conditions: Migraine
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 19
Sponsor: Richard L. Roudebush VA Medical Center
Location: West Haven VAMC West Haven Connecticut
Summary
The purpose of this study is to determine feasibility and acceptability of telehealth music imagery for migraine (Aim 1) and to explore whether there are clinically meaningful changes in headache frequency and associated patient-centered outcomes (Aim 2).
Eligibility Criteria
Inclusion Criteria:
* A migraine headache ICD-10 diagnosis, and confirmed by the American Migraine Prevalence and Prevention (AMPP) assessment.
* Completion of at least 28 headache diary days
* A confirmed frequency of ≥4 headache days per month
* Confirmed access to a smartphone, computer/tablet
* A primary pain complaint of headache. Patients must be stabilized on their headache medications. Patients must be on their current headache medications for the last 3 months and have no known future changes to those medications for the next 3 months from the start of enrollment.
Exclusion Criteria:
* Non-Veterans
* Veterans without a migraine headache ICD-10 diagnosis
* Veterans without a migraine headache confirmation from AMPP
* Veterans whose primary pain complaint is not headache
* Veterans who do not speak English
* Veterans with a significant cognitive impairment based on EHR ICD10 diagnosis \[Mild Cognitive Impairment G31.84; Dementia F03.90; Alzheimer's Dementia G30.9\] and confirmed by the Short Portable Mental Status Questionnaire (SPMSQ)19 cognitive screener during the initial baseline assessment. Veterans with a hearing deficit that would impair participation in the MI intervention
* Veterans who have a diagnosis of Traumatic Brain Injury ≤ 1 year before diagnosis of migraine or worsening of migraine as indicated by post-traumatic headache screening tool
* Veterans currently suffering from a disabling psychiatric illness (as noted by clinician); or psychiatric hospitalization in the last 6 months
* Veterans who have active psychotic symptoms, suicidality, or severe depressive symptoms (PHQ score \>20) per patient report and/or EHR notes
* Veterans who have had suicidal and/or homicidal ideation in the past 6 months.
* Veterans who decline to or cannot pass the tech screening4b
* Veterans receiving hospice or palliative care
* Veterans who do not have access to smartphone, computer/tablet
Source: ClinicalTrials.gov (NCT06440876). StuddyBuddy aggregates publicly available trial information.