Feasibility and Acceptability of Music Therapy for Chronic Pain (FAMILIA)

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status: Enrolling

Conditions: Chronic Pain

Treatments: Behavioral: Music Imagery; Behavioral: Music Listening

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05426941

1863501-22-C-20

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Music Imagery

Experimental group

Description:

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.

Treatment:

Behavioral: Music Imagery

Music Listening

Experimental group

Description:

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.

Treatment:

Behavioral: Music Listening

Usual care

No Intervention group

Description:

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.