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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
25
See music and imagery arm description.
Feasibility metrics
Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments
Time frame: 2 months
Acceptability interviews
Veterans will be interviewed after completing study sessions to assess experiences of telehealth MI; aspects of the intervention, especially virtually delivery, that Veterans perceive to be most/least helpful or most/least liked; barriers and facilitators to study participation; how the music interventions compare to other migraine treatments already tried.
Time frame: 6 month
Headache Diary
Log of headache frequency and characteristics
Time frame: Baseline and 3 months
Music Diary
Log of music listening frequency
Time frame: During active music intervention (months 1-2)
Patient Health Questionnaire (PHQ-9)
Depression, self-reported assessment
Time frame: 3 month
Migraine Disability Assessment
5 item self reported assessment for headache-related disability
Time frame: baseline and 3 month
Veterans RAND 12-item (VR-12)
12-item, self-report measure of health-related quality life
Time frame: baseline and 3 month
Generalized Anxiety Disorder Screener (GAD-7)
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7-item, self-report measure of anxiety
Time frame: baseline and 3 month
Post-Traumatic Stress Disorder Checklist (PCL-5)
a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD
Time frame: baseline and 3 month
Headache Pain Catastrophizing Scale (HPCS)
The HPCS is a 13-item self-report measure of catastrophic thinking related to headache
Time frame: baseline and 3 month
Headache Management Self-Efficacy Scale (HMSE)
a 25-item self-report questionnaire related to a person's confidence in their ability to manage their headache symptoms
Time frame: baseline and 3 month
Patient Global Perception of Change (PGPC)
single item scale measures the participant's perception of improvement since the start of the study
Time frame: 3 month