Interactive Music And Guided Imagery for Nonpharma Headache Ease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 主要终点
- Feasibility metrics
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Feasibility metrics
时间窗: 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
时间窗: 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.
次要结局
- Patient Health Questionnaire (PHQ-9)(3 month)
- Migraine Disability Assessment(baseline and 3 month)
- Generalized Anxiety Disorder Screener (GAD-7)(baseline and 3 month)
- Post-Traumatic Stress Disorder Checklist (PCL-5)(baseline and 3 month)
- Headache Diary(Baseline and 3 months)
- Music Diary(During active music intervention (months 1-2))
- Patient Global Perception of Change (PGPC)(3 month)
- Veterans RAND 12-item (VR-12)(baseline and 3 month)
- Headache Pain Catastrophizing Scale (HPCS)(baseline and 3 month)
- Headache Management Self-Efficacy Scale (HMSE)(baseline and 3 month)
研究者
Kristin Story
Principal Investigator
Richard L. Roudebush VA Medical Center