Music and Imagery for Veterans With Migraine Headache

NCT06440876 | Not Yet Recruiting DMC

• 1 other identifier: 19092
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Headache Diary

  Baseline and 3 months

• Music Diary

  During active music intervention (months 1-2)

• Patient Health Questionnaire (PHQ-9)

  3 month

• Migraine Disability Assessment

  baseline and 3 month

• Veterans RAND 12-item (VR-12)

  baseline and 3 month

Study Arms (1)

Music and Imagery

EXPERIMENTAL

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

Interventions

Music and Imagery BEHAVIORAL

See music and imagery arm description.

Also known as: MI; Supportive MI

Music and Imagery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Richard L. Roudebush VA Medical Center: lead
• VA Connecticut Healthcare System: collaborator

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Kristin M Story, PhD

CONTACT

317-554-0000; kristin.story@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kristin Maya Story

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 4, 2024
• Study Start: June 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: August 15, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share