Stepped-Care Intervention of Music and Imagery to Assess Relief (SCIMITAR) Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stepped-care.
- Who it may be relevant to
- Registry conditions: Chronic Musculoskeletal Pain, Veterans, Music Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Behavioral Stepped-care
Music listening in Step 1 and Music and imagery in step 2
Primary outcome measures
- Brief Pain Inventory - Pain Interference [Time frame: baseline, 1, 3, and 6 months]
Secondary outcome measures (8)
- Numeric rating scale [Time frame: baseline, 1, 3, and 6 months]
- Patient Global Impression of Change [Time frame: 1, 3, and 6 months]
- PROMIS Sleep Scale [Time frame: baseline, 1, 3, and 6 months]
- GAD-7 Anxiety [Time frame: baseline, 1, 3, and 6 months]
- PHQ-9 Depression [Time frame: baseline, 1, 3, and 6 months]
- PC PTSD Screen [Time frame: baseline, 1, 3, and 6 months]
- Perceived Stress Scale [Time frame: baseline, 1, 3, and 6 months]
- Mood regulation (B-MMR) [Time frame: baseline, 1, 3, and 6 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Veterans Health Indiana — Indianapolis
Identifiers
NCT: NCT07217821 · 1903704-22-C-22 · 66974