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

NCT ID: NCT07217821

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2026-04-30

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.

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.

Conditions

Chronic Musculoskeletal Pain; Veterans; Music Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Stepped-care

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stepped-care

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Stepped-care music therapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana Institute for Medical Research

OTHER

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Veterans Health Indiana

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sara M Kass, MD

Role: CONTACT

skass@hjf.org

240-463-2600

Marianne Spevak, BSHS

Role: CONTACT

mspevak@hjf.org

240-694-2067

Facility Contacts

Matthew J Bair, MD

Role: primary

Matthew.Bair@va.gov

317-988-2058

Barry Barker, MS

Role: backup

Barry.Barker@va.gov

765-238-0855

Other Identifiers

66974

Identifier Type: OTHER

Identifier Source: secondary_id

1903704-22-C-22

Identifier Type: -

Identifier Source: org_study_id