MigraineIMAGINENCT06440876
Music and Imagery for Veterans With Migraine Headache
A study testing Music and Imagery in people with Migraine, run by Richard L. Roudebush VA Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Music and Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Migraine
- Being tested
- Music and Imagery
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music and ImageryBehavioural
Also called MI; Supportive MI
See music and imagery arm description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Music and Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility metrics
Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments
Measured: 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.
Measured: 6 month
Secondary outcomes (10)
Headache Diary
Log of headache frequency and characteristics
Measured: Baseline and 3 months
Music Diary
Log of music listening frequency
Measured: During active music intervention (months 1-2)
Patient Health Questionnaire (PHQ-9)
Depression, self-reported assessment
Measured: 3 month
Migraine Disability Assessment
5 item self reported assessment for headache-related disability
Measured: baseline and 3 month
Veterans RAND 12-item (VR-12)
12-item, self-report measure of health-related quality life
Measured: baseline and 3 month
Generalized Anxiety Disorder Screener (GAD-7)
7-item, self-report measure of anxiety
Measured: 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
Measured: baseline and 3 month
Headache Pain Catastrophizing Scale (HPCS)
The HPCS is a 13-item self-report measure of catastrophic thinking related to headache
Measured: 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
Measured: 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
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start15 Jun 2024
- Primary completion30 Nov 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard L. Roudebush VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- VA Connecticut Healthcare System
- Responsible party
- Principal investigator, Kristin Story, Richard L. Roudebush VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440876
- Sponsor's protocol ID
- 19092
- Acronym
- IMAGINE
- Status last verified
- Aug 2026
- First submitted
- 28 May 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Music And Guided Imagery for Nonpharma Headache Ease
- ClinicalTrials.gov ID
- NCT06440876
- Acronym / sponsor ID
- IMAGINE / 19092
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Richard L. Roudebush VA Medical CenterUS federal agency
- Collaborators
- VA Connecticut Healthcare System
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music and Imagery | Experimental | Behavioral: Music and ImageryMI 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music and ImageryAlso: MI; Supportive MISee music and imagery arm description. | Behavioural | Music and Imagery |
Primary outcome
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
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.
10 secondary outcomes
Headache Diary
Time frame: Baseline and 3 months
Music Diary
Time frame: During active music intervention (months 1-2)
Patient Health Questionnaire (PHQ-9)
Time frame: 3 month
Migraine Disability Assessment
Time frame: baseline and 3 month
Veterans RAND 12-item (VR-12)
Time frame: baseline and 3 month
Generalized Anxiety Disorder Screener (GAD-7)
Time frame: baseline and 3 month
Post-Traumatic Stress Disorder Checklist (PCL-5)
Time frame: baseline and 3 month
Headache Pain Catastrophizing Scale (HPCS)
Time frame: baseline and 3 month
Headache Management Self-Efficacy Scale (HMSE)
Time frame: baseline and 3 month
Patient Global Perception of Change (PGPC)
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and Imagery in people with Migraine, run by Richard L. Roudebush VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility metrics (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.