Feasibility and Acceptability of Music Therapy for Chronic Pain

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

Sponsors

Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborator: VA Office of Research and Development
Indiana Institute for Medical Research

Source Henry M. Jackson Foundation for the Advancement of Military Medicine
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.

Overall Status Recruiting
Start Date 2021-09-01
Completion Date 2023-09-30
Primary Completion Date 2023-08-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments? at 3 months
Aspects of the interventions do Veterans perceive to be most/least helpful or most/least liked? at 3 months
Secondary Outcome
Measure Time Frame
Numeric Rating Scale for Pain intensity Baseline, 1, 3, and 4 months
Brief Pain Inventory - Pain interference subscale Baseline, 1, 3, and 4 months
Brief Pain Catastrophizing Scale Baseline, 1, 3, and 4 months
Centrality of Pain Scale Baseline, 1, 3, and 4 months
Patient Global Impression of Change Scale 1,3 and 4 months
PROMIS Sleep Scale Baseline, 1, 3, and 4 months
PHQ-9 Depression Measure Baseline, 1, 3, and 4 months
GAD-7 Anxiety Measure Baseline, 1, 3, and 4 months
Perceived Stress Scale Baseline and 3 months
EQ 5D Scale for Health-Related Quality of Life Baseline and 3 months
EQ 5D Scale for Health-Related Quality of Life Baseline and 3 months
Enrollment 60
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Music Imagery

Description: Up to 30 participants will be randomized to receive 8 weekly Music Imagery sessions over 8-12 weeks.

Arm Group Label: Music Imagery

Other Name: music therapy

Intervention Type: Behavioral

Intervention Name: Music Listening

Description: Up to 15 participants will be randomized to independent music listening.

Arm Group Label: Music Listening

Other Name: music therapy

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Overall Contact

Last Name: Barry Barker

Phone: 317-988-4312

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Roudebush VA Medical Center Barry Barker 317-988-4312 [email protected]
Location Countries

United States

Verification Date

2022-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Music Imagery

Type: Experimental

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.

Label: Music Listening

Type: Experimental

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.

Label: Usual care

Type: No Intervention

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.

Acronym FAMILIA
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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