Stepped-Care Intervention of Music and Imagery to Assess Relief (SCIMITAR) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory - Pain Interference
研究概览
简要总结
Th Stepped-Care Intervention of Music and Imagery to Assess Relief (SCIMITAR) Trial. SCIMITAR builds on our pilot study, the Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia (FAMILIA), which demonstrated that telehealth delivery of music listening (ML) and music imagery (MI) interventions is feasible and acceptable to Veterans with chronic musculoskeletal pain. SCIMITAR leverages what we learned from FAMILIA into a fully powered trial, harnessing the benefits of sequential ML and MI into a stepped-care, music therapy intervention via telehealth for Veterans needing relief from pain.
详细描述
More than 100 million Americans have chronic pain. Chronic pain affects 40%-70% of Veterans and is a leading cause of disability, with a substantial negative impact on millions of veterans' lives. Chronic pain is frequently accompanied by psychological comorbidity that adds to patient suffering and complicates treatment. Veterans with pain and PTSD demonstrate greater pain, depression, and healthcare utilization, and patients with comorbid pain and depression have worse outcomes than patients with pain or depression alone. Musculoskeletal (MSK) pain conditions are widespread, accounting for two-thirds of all clinical visits for pain. There is a pressing need to provide effective, non-pharmacological treatment to Veterans with chronic MSK pain. To improve pain-related outcomes, the VA recommends an integrative and stepped-care approach to pain management, including non-pharmacological treatments.
The SCIMITAR Trial is a 2-arm, parallel group, randomized controlled trial. After providing informed consent and completing their baseline assessment, participants will be randomized in a 1:1 allocation ratio to a stepped-care music intervention or waitlist control. The study population will include 180 Veterans with chronic MSK pain.
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)
盲法说明
Outcome assessors are blinded to study arm allocation
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
- •musculoskeletal pain in the low back, cervical spine, or extremities (hips, knees, or shoulders) for ≥ 3 months
- •at least moderate pain severity, defined as a PEG score ≥ 4 on a 0 (no pain) to 10 (worst pain)
- •access to computer, tablet, or smartphone
- •ability to pass a technology assessment
排除标准
- •Past month hospitalization for medical or psychiatric illness
- •housing insecurity
- •suicidal ideation with current intent/plan
- •hearing or cognitive impairment that may interfere with music listening or abstract thinking needed for imagery work
- •currently receiving music therapy services
研究组 & 干预措施
Stepped-care
Step 1, Music Listening (ML): a music therapist will meet with the Veteran once to identify: musical tastes, preferences and activities. From this meeting a playlist will be compiled for the Veteran to listen to during the 4-week treatment period (step 1). Participants will be asked to listen to music for a minimum of 15 minutes per day at least 4 days per week.
Step 2, Music Imagery (MI): Participants who move to step 2 will receive 8 weekly MI sessions over 8-10 weeks. The 8-session protocol has two stages. Stage 1 (sessions 1-4) is focused on learning to use music and imagery for self-regulation. Stage 2 (sessions 5-8) focuses on identifying and deepening inner resources and learning how to utilize them for self-care. Imagery is used during both stages, but becomes a central focus during Stage 2.
干预措施: Stepped-care (Behavioral)
Waitlist control
Wait-list Control: Following the 6-month outcome assessment, participants in the wait-list control arm will be offered abbreviated treatment of 3 sessions with a music therapist (one session to introduce ML with the option to receive 2 additional MI sessions). Participants will also be offered a referral to music therapy services. Participants in the wait-list control arm (and stepped-care group) may receive other pain treatments such as analgesics and non-pharmacological options (e.g., physical therapy) for their chronic MSK pain. The wait-list control arm will provide an untreated comparison to stepped-care and music therapy to assess outcomes during the same trial period, while still offering participants music therapy at study end if desired.
结局指标
主要结局
Brief Pain Inventory - Pain Interference
时间窗: baseline, 1, 3, and 6 months
Assesses how pain interferes with 7 activities of daily living
次要结局
- Numeric rating scale(baseline, 1, 3, and 6 months)
- Patient Global Impression of Change(1, 3, and 6 months)
- PROMIS Sleep Scale(baseline, 1, 3, and 6 months)
- GAD-7 Anxiety(baseline, 1, 3, and 6 months)
- PHQ-9 Depression(baseline, 1, 3, and 6 months)
- PC PTSD Screen(baseline, 1, 3, and 6 months)
- Perceived Stress Scale(baseline, 1, 3, and 6 months)
- Mood regulation (B-MMR)(baseline, 1, 3, and 6 months)