Music and Imagery for Veterans With Migraine Headache

Migraine Clinical Trial

— IMAGINE  

Official title:

Interactive Music And Guided Imagery for Nonpharma Headache Ease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06440876
• Other study ID #: 19092
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: August 15, 2025

Study information

• Verified date: May 2024
• Source: Richard L. Roudebush VA Medical Center
• Contact: Kristin M Story, PhD
• Phone: 317-554-0000
• Email: kristin.story[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: August 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Music and Imagery
See music and imagery arm description.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Richard L. Roudebush VA Medical Center	VA Connecticut Healthcare System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Headache Diary	Log of headache frequency and characteristics	Baseline and 3 months
Secondary	Music Diary	Log of music listening frequency	During active music intervention (months 1-2)
Secondary	Patient Health Questionnaire (PHQ-9)	Depression, self-reported assessment	3 month
Secondary	Migraine Disability Assessment	5 item self reported assessment for headache-related disability	baseline and 3 month
Secondary	Veterans RAND 12-item (VR-12)	12-item, self-report measure of health-related quality life	baseline and 3 month
Secondary	Generalized Anxiety Disorder Screener (GAD-7)	7-item, self-report measure of anxiety	baseline and 3 month
Secondary	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
Secondary	Headache Pain Catastrophizing Scale (HPCS)	The HPCS is a 13-item self-report measure of catastrophic thinking related to headache	baseline and 3 month
Secondary	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
Secondary	Patient Global Perception of Change (PGPC)	single item scale measures the participant's perception of improvement since the start of the study	3 month