About this trial
This randomized controlled trial will evaluate the effectiveness of an 8-week group music therapy intervention for active duty service members with chronic pain. Participants will be randomized to either a group music therapy intervention plus standard care or standard care alone. Outcomes will be assessed at baseline, post- treatment (8 weeks), and 1-month follow-up. Primary outcomes include pain interference and pain intensity. Secondary outcomes include pain-related self-efficacy, depression, anxiety, positive affect, sleep disturbance, patient perception of change, and pain medication use. Qualitative interviews will be conducted with a subset of participants who receive music therapy to explore subjective experiences and perceived treatment benefits.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Active duty service member
Age 18 -64 years of age
Diagnosis of chronic benign pain for at least 3 months
Average pain severity greater than 4/10 on the Defense and Veterans Pain Rating Scale
Disqualifiers
Pregnancy
Mental health conditions that would prevent compliance with or productive participation in group sessions
Cognitive impairment preventing completion of study measures
Malignant disease
Trial design
Parallel
Treatments tested in this trial
Music intervention
BehavioralAn 8-week standardized music therapy protocol delivered in weekly 75-minute group sessions. The intervention is guided by a biopsychosocial framework and includes music-guided breathing, relaxation exercises, group improvisation, processing of music experiences, meaningful music listening, and home practice of music-based pain management skills.
Treatment groups
Trial outcomes
Primary outcomes
Pain Intensity
As measured by the Defense and Veterans Pain Rating Scale (DVPRS), where each item is scored 0-10 and a higher total score indicates a worse outcome.
Pain Interference
As measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 8-item Scale, where each item is scored 1-5 and a higher total score indicates a worse outcome.
Secondary outcomes
Pain-related self-efficacy
As measured by the 6-item University of Washington Pain Related Self-Efficacy Scale (UWPRSE), where each item is scored 1-5 and a higher total score indicates a better outcome.
Depression
As measured by the 9-item Patient Health Questionnaire scale (PHQ-9), where each item is scored 0-3 and a higher total score indicates a worse outcome.
Anxiety
As measured by the 7-item Generalized Anxiety Disorder Scale (GAD-7), where each item is scored 0-3 and a higher total score indicates a worse outcome.
Positive Well-Being
As measured by the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS), where each item is scored 1-5 and a higher total score indicates a better outcome.
Other outcomes
Post-Traumatic Stress Symptoms (Moderator)
As measured by the PTSD Checklist for DSM-5 (PCL-5), where each item is scored 0-4 and a higher total score indicates a worse outcome.
Sponsors and contacts
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Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead sponsor
Drexel University
Collaborator
Joint Base Elmendorf-Richardson
Collaborator