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NCT Number: NCT07217821

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stepped-care

Behavioral

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

Other names: Stepped-care music therapy

Primary outcomes

  1. Brief Pain Inventory - Pain Interference

    Time frame: baseline, 1, 3, and 6 months

    Assesses how pain interferes with 7 activities of daily living

Secondary outcomes

  1. Numeric rating scale

    Time frame: baseline, 1, 3, and 6 months

    Assess pain severity

  2. Patient Global Impression of Change

    Time frame: 1, 3, and 6 months

    Assess treatment response

  3. PROMIS Sleep Scale

    Time frame: baseline, 1, 3, and 6 months

    Assesses quality of sleep

  4. GAD-7 Anxiety

    Time frame: baseline, 1, 3, and 6 months

    Assesses anxiety symptoms

  5. PHQ-9 Depression

    Time frame: baseline, 1, 3, and 6 months

    Assesses depression symptoms

  6. PC PTSD Screen

    Time frame: baseline, 1, 3, and 6 months

    Screens for PTSD

  7. Perceived Stress Scale

    Time frame: baseline, 1, 3, and 6 months

    Assesses stress

  8. Mood regulation (B-MMR)

    Time frame: baseline, 1, 3, and 6 months

    Assesses ability to regulate mood

Study contacts

Contact information is provided by the study sponsor or research team.

Marianne Spevak, BSHS

CONTACT

[email protected]

240-694-2067

Sara M Kass, MD

CONTACT

[email protected]

240-463-2600

Sponsors and collaborators

Lead sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Other

Collaborators

  • Indiana Institute for Medical Research

Registry information

Acronym: SCIMITAR

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2025
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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