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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06440876
Other study ID # 19092
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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