Feasibility and Acceptability of Music Imagery, and Listening Interventions for Analgesia (FAMILIA)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments?
研究概览
简要总结
The purpose of the study is to examine the feasibility and acceptability of two music interventions delivered through telehealth for chronic musculoskeletal pain. This pilot study evaluates outcomes (feasibility, acceptability, pain and associated outcomes) in a single-component, minimally interactive music listening (ML) intervention and a multi-component, more interactive music imagery (MI) intervention.
详细描述
FAMILIA is a 3-arm, parallel group, pilot trial. Sixty Veterans will be randomized to one of three conditions: MI, ML, or usual care. Aim 1 is to test the feasibility and acceptability of a multi-component, interactive MI intervention (8-weekly, individual sessions) and a single-component, minimally interactive ML intervention (independent music listening). Feasibility metrics related to recruitment, retention, engagement, and completion of treatment protocol and questionnaires will be assessed. Up to 20 qualitative interviews will be conducted to assess Veteran experiences with both interventions, including perceived benefits, acceptability, barriers, and facilitators. Interview transcripts will be coded and analyzed for emergent themes. Aim 2 is to explore the effects of MI and ML versus usual care on pain and associated patient-centered outcomes. These outcomes and potential mediators will be explored through changes from baseline to follow-up assessments at 1, 3, and 4 months. Descriptive statistics will be used to describe outcomes; this pilot study is not powered to detect differences in outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chronic (> 6 months) musculoskeletal pain of at least moderate severity (≥5 on 0-10 numeric scale)
- •Access to a personal computer, tablet computer, and/or smartphone,
- •Ability to pass technology assessment screen, and
- •Not currently receiving music therapy services
排除标准
- •Serious or unstable medical (e.g., Congestive Heart Failure, Chronic Obstructive Pulmonary Disease) or psychiatric illness (e.g., psychosis, mania) or housing insecurity that could compromise study participation,
- •Suicidal ideation with current intent/plan,
- •Hearing or cognitive impairment that may interfere with music listening or abstract thinking needed for imagery work,
- •Lack access to a personal computer, tablet computer, and/or smartphone,
- •Unable to pass technology assessment screen, or
- •Currently receiving music therapy services.
结局指标
主要结局
Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments?
时间窗: at 3 months
Determine the feasibility of the music therapy interventions
Aspects of the interventions do Veterans perceive to be most/least helpful or most/least liked?
时间窗: at 3 months
Assess participant acceptability of the music therapy interventions
次要结局
- Numeric Rating Scale for Pain intensity(Baseline, 1, 3, and 4 months)
- Patient Global Impression of Change Scale(1,3 and 4 months)
- PROMIS Sleep Scale(Baseline, 1, 3, and 4 months)
- PHQ-9 Depression Measure(Baseline, 1, 3, and 4 months)
- GAD-7 Anxiety Measure(Baseline, 1, 3, and 4 months)
- Perceived Stress Scale(Baseline and 3 months)
- Brief Pain Inventory - Pain interference subscale(Baseline, 1, 3, and 4 months)
- Brief Pain Catastrophizing Scale(Baseline, 1, 3, and 4 months)
- Centrality of Pain Scale(Baseline, 1, 3, and 4 months)
- EQ 5D Scale for Health-Related Quality of Life(Baseline and 3 months)