Veterans Health Indiana
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
Location contact
Barry Barker, MS
CONTACT
Matthew J Bair, MD
CONTACT
NCT Number: NCT07217821
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
Barry Barker, MS
CONTACT
Matthew J Bair, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Music listening in Step 1 and Music and imagery in step 2
Other names: Stepped-care music therapy
Time frame: baseline, 1, 3, and 6 months
Assesses how pain interferes with 7 activities of daily living
Time frame: baseline, 1, 3, and 6 months
Assess pain severity
Time frame: 1, 3, and 6 months
Assess treatment response
Time frame: baseline, 1, 3, and 6 months
Assesses quality of sleep
Time frame: baseline, 1, 3, and 6 months
Assesses anxiety symptoms
Time frame: baseline, 1, 3, and 6 months
Assesses depression symptoms
Time frame: baseline, 1, 3, and 6 months
Screens for PTSD
Time frame: baseline, 1, 3, and 6 months
Assesses stress
Time frame: baseline, 1, 3, and 6 months
Assesses ability to regulate mood
Contact information is provided by the study sponsor or research team.
Marianne Spevak, BSHS
CONTACT
Sara M Kass, MD
CONTACT
Henry M. Jackson Foundation for the Advancement of Military Medicine
Other
Acronym: SCIMITAR
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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