- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07755540
Group Music Therapy for Chronic Pain Management in Active Duty Service Members
Group Music Therapy for Chronic Pain Management in Active Duty Service Members With Chronic Pain: A Randomized Controlled Trial
Study Overview
Detailed Description
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
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Joke Bradt, PhD
- Phone Number: 2673595508
- Email: jbradt@drexel.edu
Study Locations
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Alaska
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Anchorage, Alaska, United States, 99505
- Recruiting
- Joint Base Elmendorf-Richardson (JBER)
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Contact:
- Earl J Banning, PsyD
- Phone Number: 9075800014
- Email: earl.j.banning.mil@health.mil
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Principal Investigator:
- Earl J Banning, PsyD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- Able to read and understand English
Exclusion Criteria:
- Pregnancy
- Mental health conditions that would prevent compliance with or productive participation in group sessions
- Cognitive impairment preventing completion of study measures
- Malignant disease
- Progressive neurological disorder
- Moderate to profound hearing impairment not corrected with hearing aids
- Previous participation in music therapy services at Joint Base Elmendorf-Richardson (JBER)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group Music Therapy + Standard Care
Participants will receive eight weekly 75-minute group music therapy sessions in addition to standard pain management care.
Sessions include music-guided breathing, relaxation exercises, group improvisation, music listening, discussion, and music-based pain self-management training.
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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:
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No Intervention: Standard Care
Participants will receive standard pain management services available at Joint Base Elmendorf-Richardson.
These may include medication management, physical therapy, acupuncture, cognitive behavioral therapy, and interventional pain procedures.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Baseline, Week 8, and 1-Month Follow-Up as well as pre and post- session
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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.
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Baseline, Week 8, and 1-Month Follow-Up as well as pre and post- session
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Pain Interference
Time Frame: Baseline, Week 8, and 1-Month Follow-Up
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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.
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Baseline, Week 8, and 1-Month Follow-Up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Medication Use
Time Frame: Baseline, Week 8, 1-Month Follow-Up
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Medication use from participant daily reports for 7 days
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Baseline, Week 8, 1-Month Follow-Up
|
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Pain-related self-efficacy
Time Frame: Baseline, Week 8, 1-Month Follow-Up
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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.
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Baseline, Week 8, 1-Month Follow-Up
|
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Depression
Time Frame: Baseline, Week 8, 1-Month Follow-Up
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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.
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Baseline, Week 8, 1-Month Follow-Up
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Anxiety
Time Frame: Baseline, Week 8, 1-Month Follow-Up
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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.
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Baseline, Week 8, 1-Month Follow-Up
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Positive Well-Being
Time Frame: Baseline, Week 8, 1-Month Follow-Up
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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.
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Baseline, Week 8, 1-Month Follow-Up
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Sleep Disturbance
Time Frame: Baseline, Week 8, 1-Month Follow-Up
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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.
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Baseline, Week 8, 1-Month Follow-Up
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Disability
Time Frame: Baseline, Week 8, 1-Month Follow-Up
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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.
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Baseline, Week 8, 1-Month Follow-Up
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Patient Perception of Change
Time Frame: Week 8, 1-Month Follow-Up
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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.
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Week 8, 1-Month Follow-Up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post-Traumatic Stress Symptoms (Moderator)
Time Frame: Baseline
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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.
|
Baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Paul Pasquina, MD, Uniformed Services University of the Health Sciences
- Principal Investigator: Joke Bradt, PhD, Drexel University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HU00012420072
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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