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NCT07217821NARecruiting

Stepped-Care Intervention of Music and Imagery to Assess Relief (SCIMITAR) Trial

Henry M. Jackson Foundation for the Advancement of Military Medicine

Start Date

8/30/2023

Completion Date

4/30/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

Stepped-care

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Conditions

Chronic Musculoskeletal PainVeteransMusic Therapy

Locations

Veterans Health Indiana

Indianapolis, Indiana 46202

United States