Joint Base Elmendorf-Richardson (JBER)
Anchorage, Alaska, 99505, United States
Location status: Recruiting
Location contact
Earl J Banning, PsyD
CONTACT
Earl J Banning, PsyD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07755540
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.
Interested in participating?
Request Info18 year–64 year
All sexes
Interventional
Phase 2
Anchorage, Alaska, 99505, United States
Location status: Recruiting
Earl J Banning, PsyD
CONTACT
Earl J Banning, PsyD
PRINCIPAL_INVESTIGATOR
Chronic pain is a significant health concern among military personnel and veterans and is associated with disability and reduced quality of life. Music therapy is a non-pharmacological intervention that may address biological, psychological, and social factors contributing to chronic pain.
This mixed-methods research study embeds qualitative inquiry within a randomized controlled trial. A total of 130 active duty service members with chronic pain will be randomized 1:1 to either an 8-week group music therapy intervention plus standard care or standard care alone. The music therapy intervention consists of eight weekly 75-minute sessions delivered in groups of 6-8 participants and includes music-guided breathing, music-based relaxation exercises, group improvisation, verbal processing, listening to meaningful music, and instruction in music-based pain self-management strategies.
Primary outcomes are pain interference and pain intensity. Secondary outcomes include pain-related self-efficacy, depression, anxiety, positive affect, sleep disturbance, patient global impression of change, disability, and pain medication use. Outcomes will be evaluated at baseline, week 8, and 1-month follow-up. Semi-structured interviews will be conducted with approximately 20 participants from the music therapy arm after follow-up assessment to explore treatment experiences and perceived benefits
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An 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.
Other names: Group Music Therapy
Time frame: Baseline, Week 8, and 1-Month Follow-Up as well as pre and post- session
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.
Time frame: Baseline, Week 8, and 1-Month Follow-Up
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.
Time frame: Baseline, Week 8, 1-Month Follow-Up
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.
Time frame: Baseline, Week 8, 1-Month Follow-Up
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.
Time frame: Baseline, Week 8, 1-Month Follow-Up
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.
Time frame: Baseline, Week 8, 1-Month Follow-Up
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.
Time frame: Baseline, Week 8, 1-Month Follow-Up
As measured by the 8-item PROMIS® Sleep Disturbance Short Form-8a, where each item is scored 1-5 and a higher total score indicates a worse outcome.
Time frame: Baseline, Week 8, 1-Month Follow-Up
As measured by the 10-item Oswestry Disability Index (ODI), where each item is scored 0-5 and a higher total score indicates a worse outcome.
Time frame: Week 8, 1-Month Follow-Up
As measured by the Patient Global Impression of Change Scale (PGIC), a single item scale that uses a 1-7 score and a higher score indicates a better outcome.
Time frame: Baseline, Week 8, 1-Month Follow-Up
Medication use from participant daily reports for 7 days
Time frame: Baseline
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.
Contact information is provided by the study sponsor or research team.
Henry M. Jackson Foundation for the Advancement of Military Medicine
Other
Group Music Therapy for Chronic Pain Management in Active Duty Service Members With Chronic Pain: A Randomized Controlled Trial
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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