Skip to main content
OpenTrials
Completed

NCT Number: NCT06440876

Music and Imagery for Veterans With Migraine Headache

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Haven VAMC

West Haven, Connecticut, 06516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music and Imagery

Behavioral

See music and imagery arm description.

Other names: MI; Supportive MI

Primary outcomes

  1. Feasibility metrics

    Time frame: 2 months

    Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments

  2. Acceptability interviews

    Time frame: 6 month

    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.

Secondary outcomes

  1. Headache Diary

    Time frame: Baseline and 3 months

    Log of headache frequency and characteristics

  2. Music Diary

    Time frame: During active music intervention (months 1-2)

    Log of music listening frequency

  3. Patient Health Questionnaire (PHQ-9)

    Time frame: 3 month

    Depression, self-reported assessment

  4. Migraine Disability Assessment

    Time frame: baseline and 3 month

    5 item self reported assessment for headache-related disability

  5. Veterans RAND 12-item (VR-12)

    Time frame: baseline and 3 month

    12-item, self-report measure of health-related quality life

  6. Generalized Anxiety Disorder Screener (GAD-7)

    Time frame: baseline and 3 month

    7-item, self-report measure of anxiety

  7. Post-Traumatic Stress Disorder Checklist (PCL-5)

    Time frame: baseline and 3 month

    a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD

  8. Headache Pain Catastrophizing Scale (HPCS)

    Time frame: baseline and 3 month

    The HPCS is a 13-item self-report measure of catastrophic thinking related to headache

  9. Headache Management Self-Efficacy Scale (HMSE)

    Time frame: baseline and 3 month

    a 25-item self-report questionnaire related to a person's confidence in their ability to manage their headache symptoms

  10. Patient Global Perception of Change (PGPC)

    Time frame: 3 month

    single item scale measures the participant's perception of improvement since the start of the study

Sponsors and collaborators

Lead sponsor

Richard L. Roudebush VA Medical Center

Fed

Collaborators

  • VA Connecticut Healthcare System

Registry information

Official study title

Interactive Music And Guided Imagery for Nonpharma Headache Ease

Acronym: IMAGINE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 4, 2024
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.