Music and Imagery for Veterans With Migraine Headache (IMAGINE)

Interactive Music And Guided Imagery for Nonpharma Headache Ease

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine
• Intervention / Treatment: Behavioral: Music and Imagery

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristin M Story, PhD; Phone Number: 317-554-0000; Email: kristin.story@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Music and Imagery; MI sessions will be delivered by board-certified music therapists with specialized training in MI and the study treatment protocol. The 8-session protocol has two stages. Stage 1 (sessions 1-4) is focused on learning to use music and imagery for self-regulation. Once the Veteran has demonstrated skill in using music for self-regulation, Stage 2 (sessions 5-8) shifts to identify and deepen their inner resources and how they can use those resources for self-care.

Behavioral: Music and Imagery; See music and imagery arm description.; Other Names: MI; Supportive MI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility metrics	Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments	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.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Diary	Log of headache frequency and characteristics	Baseline and 3 months
Music Diary	Log of music listening frequency	During active music intervention (months 1-2)
Patient Health Questionnaire (PHQ-9)	Depression, self-reported assessment	3 month
Migraine Disability Assessment	5 item self reported assessment for headache-related disability	baseline and 3 month
Veterans RAND 12-item (VR-12)	12-item, self-report measure of health-related quality life	baseline and 3 month
Generalized Anxiety Disorder Screener (GAD-7)	7-item, self-report measure of anxiety	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	baseline and 3 month
Headache Pain Catastrophizing Scale (HPCS)	The HPCS is a 13-item self-report measure of catastrophic thinking related to headache	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	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	3 month

Collaborators and Investigators

• Sponsor: Richard L. Roudebush VA Medical Center
• Collaborators: VA Connecticut Healthcare System

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Estimated): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: 19092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No