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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Music Imagery; Behavioral: Music Listening

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barry Barker; Phone Number: 317-988-4312; Email: Barry.Barker@va.gov
• Study Contact Backup: Name: Matthew Bair; Phone Number: 317-988-2058; Email: Matthew.Bair@va.gov

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Roudebush VA Medical Center
      • Contact: Barry Barker; Phone Number: 317-988-4312; Email: Barry.Barker@va.gov
      • Contact: Matthew Bair; Phone Number: 317-988-2058; Email: Matthew.Bair@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music Imagery; 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; Up to 30 participants will be randomized to receive 8 weekly Music Imagery sessions over 8-12 weeks.; Other Names: music therapy
Experimental: Music Listening; 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; Up to 15 participants will be randomized to independent music listening.; Other Names: music therapy
No Intervention: Usual care; 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?

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

Collaborators and Investigators

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: VA Office of Research and Development; Indiana Institute for Medical Research
• Investigators: Principal Investigator: Matthew Bair, Roudebush VA Medical Center; Principal Investigator: Maya Story, Roudebush VA Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): August 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 1863501-22-C-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No