Recruiting

Music Therapy

Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Code:

NCT07217821

Conditions

Chronic Musculoskeletal Pain

Veterans

Music Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stepped-care

Study Details

Brief 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.

Conditions

Chronic Musculoskeletal Pain

Veterans

Music Therapy

Study ID

NCT07217821

Start date

Aug 30, 2023

Status verified date

Sep, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Stepped-care

Music listening in Step 1 and Music and imagery in step 2

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sara M Kass, MD

240-463-2600skass@hjf.org

Marianne Spevak, BSHS

240-694-2067mspevak@hjf.org

Locations

Veterans Health Indiana

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Matthew J Bair, MD

317-988-2058Matthew.Bair@va.gov

Barry Barker, MS

765-238-0855Barry.Barker@va.gov

More Information

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Last update posted

Oct 16, 2025

Last verified

Sep, 2025

Keywords

  • chronic pain
  • veterans
  • musculoskeletal pain
  • music therapy
  • clinical trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine on 2025-10-16.