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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stepped-care

    Behavioral

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

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Stepped-careExperimental treatment 1 intervention
Group B: Waitlist controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Brief Pain Inventory - Pain Interference

Assesses how pain interferes with 7 activities of daily living

Time frame
baseline, 1, 3, and 6 months

Secondary outcomes

1

Numeric rating scale

Assess pain severity

Time frame
baseline, 1, 3, and 6 months
2

Patient Global Impression of Change

Assess treatment response

Time frame
1, 3, and 6 months
3

PROMIS Sleep Scale

Assesses quality of sleep

Time frame
baseline, 1, 3, and 6 months
4

GAD-7 Anxiety

Assesses anxiety symptoms

Time frame
baseline, 1, 3, and 6 months

Other outcomes

Sponsors and contacts

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