Clinical trial NCT06440876: Music and Imagery for Veterans With Migraine Headache
Official title: Interactive Music And Guided Imagery for Nonpharma Headache Ease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine
Lead sponsor: Richard L. Roudebush VA Medical Center
Sponsor class: FED
Collaborators: name: VA Connecticut Healthcare System
First posted: 2024-06-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Detailed description: IMAGINE is a single arm pilot trial. At least 10 and up to 25 Veterans with migraine headache will participate in 8-weekly one-to-one telehealth MI sessions. Sessions will be conducted via a private channel in VA Microsoft Teams, which is a VA approved platform. Each 60-minute MI session is facilitated by a music therapist and consists of 1) a verbal check-in 2) music listening (Veteran patient and therapist choose music together) 3) processing imagery elicited by music, which is done through optional artwork or discussion of the imagery 4) identification of ways to continue to work with music and imagery independently between sessions. Feasibility metrics related to recruitment, retention, engagement, and completion of treatment protocols and assessments will be evaluated. Acceptability will be measured through brief feedback from participant interviews. Qualitative interviews will be conducted to attain Veteran experiences, including perceived benefits, barriers and facilitators. Interview transcripts will be coded and analyzed for emergent themes. Aim 2 outcomes will be explored through changes in headache frequency and associated symptoms from baseline to follow-up immediately following completion of MI sessions. Descriptive statistics will be used to report outcomes. This study is not powered to detect differences in outcomes.

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

Primary outcomes:
measure: Feasibility metrics
timeFrame: 2 months
measure: Acceptability interviews
timeFrame: 6 month
Secondary outcomes:
measure: Headache Diary
timeFrame: Baseline and 3 months
measure: Music Diary
timeFrame: During active music intervention (months 1-2)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 3 month
measure: Migraine Disability Assessment
timeFrame: baseline and 3 month
measure: Veterans RAND 12-item (VR-12)
timeFrame: baseline and 3 month
measure: Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: baseline and 3 month
measure: Post-Traumatic Stress Disorder Checklist (PCL-5)
timeFrame: baseline and 3 month
measure: Headache Pain Catastrophizing Scale (HPCS)
timeFrame: baseline and 3 month
measure: Headache Management Self-Efficacy Scale (HMSE)
timeFrame: baseline and 3 month
measure: Patient Global Perception of Change (PGPC)
timeFrame: 3 month
Other outcomes:
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