Clinical trial NCT05426941: Feasibility and Acceptability of Music Therapy for Chronic Pain
Official title: Feasibility and Acceptability of Music Imagery, and Listening Interventions for Analgesia (FAMILIA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: VA Office of Research and Development
name: Indiana Institute for Medical Research
First posted: 2022-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments?
timeFrame: at 3 months
measure: Aspects of the interventions do Veterans perceive to be most/least helpful or most/least liked?
timeFrame: at 3 months
Secondary outcomes:
measure: Numeric Rating Scale for Pain intensity
timeFrame: Baseline, 1, 3, and 4 months
measure: Brief Pain Inventory - Pain interference subscale
timeFrame: Baseline, 1, 3, and 4 months
measure: Brief Pain Catastrophizing Scale
timeFrame: Baseline, 1, 3, and 4 months
measure: Centrality of Pain Scale
timeFrame: Baseline, 1, 3, and 4 months
measure: Patient Global Impression of Change Scale
timeFrame: 1,3 and 4 months
measure: PROMIS Sleep Scale
timeFrame: Baseline, 1, 3, and 4 months
measure: PHQ-9 Depression Measure
timeFrame: Baseline, 1, 3, and 4 months
measure: GAD-7 Anxiety Measure
timeFrame: Baseline, 1, 3, and 4 months
measure: Perceived Stress Scale
timeFrame: Baseline and 3 months
measure: EQ 5D Scale for Health-Related Quality of Life
timeFrame: Baseline and 3 months
measure: EQ 5D Scale for Health-Related Quality of Life
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Roudebush VA Medical Center
state: Indiana
Study officials:
affiliation: Roudebush VA Medical Center
name: Matthew Bair
role: PRINCIPAL_INVESTIGATOR
affiliation: Roudebush VA Medical Center
name: Maya Story
role: PRINCIPAL_INVESTIGATOR
References:
citation: Story KM, Bravata DM, Robb SL, Wasmuth S, Slaven JE, Whitmire L, Barker B, Menen T, Bair MJ. Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Sep 22;11(9):e38788. doi: 10.2196/38788.