Feasibility and Acceptability of Music Therapy for Chronic Pain

Study Overview
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Brief Summary
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The purpose of the study is to examine the feasibility and acceptability of two music interventions delivered through telehealth for chronic musculoskeletal pain. This pilot study evaluates outcomes (feasibility, acceptability, pain and associated outcomes) in a single-component, minimally interactive music listening (ML) intervention and a multi-component, more interactive music imagery (MI) intervention.

Detailed Description
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FAMILIA is a 3-arm, parallel group, pilot trial. Sixty Veterans will be randomized to one of three conditions: MI, ML, or usual care. Aim 1 is to test the feasibility and acceptability of a multi-component, interactive MI intervention (8-weekly, individual sessions) and a single-component, minimally interactive ML intervention (independent music listening). Feasibility metrics related to recruitment, retention, engagement, and completion of treatment protocol and questionnaires will be assessed. Up to 20 qualitative interviews will be conducted to assess Veteran experiences with both interventions, including perceived benefits, acceptability, barriers, and facilitators. Interview transcripts will be coded and analyzed for emergent themes. Aim 2 is to explore the effects of MI and ML versus usual care on pain and associated patient-centered outcomes. These outcomes and potential mediators will be explored through changes from baseline to follow-up assessments at 1, 3, and 4 months. Descriptive statistics will be used to describe outcomes; this pilot study is not powered to detect differences in outcomes.

Official Title
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Feasibility and Acceptability of Music Imagery, and Listening Interventions for Analgesia (FAMILIA)

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Music Imagery
* Behavioral: Music Listening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic (> 6 months) musculoskeletal pain of at least moderate severity (≥5 on 0-10 numeric scale) Access to a personal computer, tablet computer, and/or smartphone, Ability to pass technology assessment screen, and Not currently receiving music therapy services Exclusion Criteria: Serious or unstable medical (e.g., Congestive Heart Failure, Chronic Obstructive Pulmonary Disease) or psychiatric illness (e.g., psychosis, mania) or housing insecurity that could compromise study participation, Suicidal ideation with current intent/plan, Hearing or cognitive impairment that may interfere with music listening or abstract thinking needed for imagery work, Lack access to a personal computer, tablet computer, and/or smartphone, Unable to pass technology assessment screen, or Currently receiving music therapy services.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Imagery<br>MI sessions will be delivered by board-certified music therapists with specialized training in MI and the study treatment protocol.The 8-session protocol has two stages. Stage 1 (sessions 1-4) is focused on learning to use music and imagery for self-regulation. Once the Veteran has demonstrated skill in using music for self-regulation, Stage 2 (sessions 5-8) shifts to identify and deepen their inner resources and how they can use those resources for self-care. | Behavioral: Music Imagery<br>* Up to 30 participants will be randomized to receive 8 weekly Music Imagery sessions over 8-12 weeks.<br>* Other names: music therapy;|
| Experimental: Music Listening<br>Following a one-time meeting with a music therapist, an electronic playlist will be compiled for the Veteran to listen to during the 12-week treatment period. | Behavioral: Music Listening<br>* Up to 15 participants will be randomized to independent music listening.<br>* Other names: music therapy;|
| No Intervention: Usual care<br>Participants in the usual care arm (as is the case for MI and ML groups) may receive analgesics and non-pharmacological treatments (e.g., physical therapy) for their chronic musculoskeletal pain. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments? | Determine the feasibility of the music therapy interventions | at 3 months | 
| Aspects of the interventions do Veterans perceive to be most/least helpful or most/least liked? | Assess participant acceptability of the music therapy interventions | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale for Pain intensity | assessment of severity of pain, scored 0 to 10 with higher scores representing more intense pain | Baseline, 1, 3, and 4 months | 
| Brief Pain Inventory - Pain interference subscale | how does pain interfere with 7 activities, scored 0 to 10 with higher scores representing more interference of pain with activities | Baseline, 1, 3, and 4 months | 
| Brief Pain Catastrophizing Scale | assessment of pain belief, scored 0 to 12 with higher scores representing more pain catastrophizing (worse outcome) | Baseline, 1, 3, and 4 months | 
| Centrality of Pain Scale | assessment of pain coping, scored 10 to 50 with higher scores representing the belief that pain is central to individual's life (worse outcome) | Baseline, 1, 3, and 4 months | 
| Patient Global Impression of Change Scale | assessment of treatment response, scored 1 to 7 with higher scores representing greater improvement from starting the intervention | 1,3 and 4 months | 
| PROMIS Sleep Scale | assessment of sleep quality, scored 1 to 5 with higher scores representing worse sleep quality (worse outcome) | Baseline, 1, 3, and 4 months | 
| PHQ-9 Depression Measure | assessment of depression severity, scored 0 to 27 with higher scores representing more severe depression (worse outcome) | Baseline, 1, 3, and 4 months | 
| GAD-7 Anxiety Measure | assessment of anxiety severity, scored 0 to 21 with higher scores representing more severe anxiety (worse outcome) | Baseline, 1, 3, and 4 months | 
| Perceived Stress Scale | assessment of stress severity, scored 0 to 14 with higher scores representing more severe stress (worse outcome) | Baseline and 3 months | 
| EQ 5D Scale for Health-Related Quality of Life | assessment of generic health-related quality of life, higher scores represent improved quality of life | Baseline and 3 months | 
| EQ 5D Scale for Health-Related Quality of Life | assessment of generic health-related quality of life, scored 0 to 100 with higher scores represent improved quality of life (better outcome) | Baseline and 3 months |