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

NCT07217821 | Recruiting

• 2 other identifiers: 1903704-22-C-2266974
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory - Pain Interference

  Assesses how pain interferes with 7 activities of daily living

  baseline, 1, 3, and 6 months

Secondary Outcomes (8)

• 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

Study Arms (2)

Stepped-care

EXPERIMENTAL

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.

Behavioral: Stepped-care

Waitlist control

NO INTERVENTION

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 BEHAVIORAL

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

Also known as: Stepped-care music therapy

Stepped-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Indiana Institute for Medical Research: collaborator

Study Sites (1)

Veterans Health Indiana

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Central Study Contacts

Sara M Kass, MD

CONTACT

240-463-2600; skass@hjf.org

Marianne Spevak, BSHS

CONTACT

240-694-2067; mspevak@hjf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to study arm allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The SCIMITAR Trial is a 2-arm, parallel-group, randomized controlled trial. Participants will be randomized in a 1:1 allocation ratio to a stepped-care music intervention or a waitlist control.

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 16, 2025
• Study Start: August 30, 2023
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-09

Locations

US (1)