Group Music Therapy for Chronic Pain Management in Active Duty Service Members

ConditionChronic Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Music intervention

    Behavioral

    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.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Group Music Therapy + Standard CareExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Week 8, and 1-Month Follow-Up as well as pre and post- session
2

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.

Time frame
Baseline, Week 8, and 1-Month Follow-Up

Secondary outcomes

1

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.

Time frame
Baseline, Week 8, 1-Month Follow-Up
2

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.

Time frame
Baseline, Week 8, 1-Month Follow-Up
3

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.

Time frame
Baseline, Week 8, 1-Month Follow-Up
4

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.

Time frame
Baseline, Week 8, 1-Month Follow-Up

Other outcomes

1

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.

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead sponsor

Drexel University

Collaborator

Joint Base Elmendorf-Richardson

Collaborator