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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study ID
NCT07217821
Status
Recruiting
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Conditions

  • Chronic Musculoskeletal Pain
  • Music Therapy
  • Veterans

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stepped-care — BEHAVIORAL
    Music listening in Step 1 and Music and imagery in step 2

Study Details

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.

Key Dates

Start date
Aug 30, 2023
Status verified
Sep 2025
Primary completion
Jan 31, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

Brief Pain Inventory - Pain Interference [ Time Frame: baseline, 1, 3, and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Veterans Health IndianaIndianapolisIndiana46202
Matthew J Bair, MD
[email protected]
317-988-2058
Barry Barker, MS
[email protected]
765-238-0855

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By research site
Veterans Health Indiana· Indianapolis, IN

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