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

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Imagery
Music Listening
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Roudebush VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Music Imagery

Music Listening

Usual care

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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
Aspects of the interventions do Veterans perceive to be most/least helpful or most/least liked?
Assess participant acceptability of the music therapy interventions

Secondary Outcome Measures

Numeric Rating Scale for Pain intensity
assessment of severity of pain, scored 0 to 10 with higher scores representing more intense pain
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
Brief Pain Catastrophizing Scale
assessment of pain belief, scored 0 to 12 with higher scores representing more pain catastrophizing (worse outcome)
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)
Patient Global Impression of Change Scale
assessment of treatment response, scored 1 to 7 with higher scores representing greater improvement from starting the intervention
PROMIS Sleep Scale
assessment of sleep quality, scored 1 to 5 with higher scores representing worse sleep quality (worse outcome)
PHQ-9 Depression Measure
assessment of depression severity, scored 0 to 27 with higher scores representing more severe depression (worse outcome)
GAD-7 Anxiety Measure
assessment of anxiety severity, scored 0 to 21 with higher scores representing more severe anxiety (worse outcome)
Perceived Stress Scale
assessment of stress severity, scored 0 to 14 with higher scores representing more severe stress (worse outcome)
EQ 5D Scale for Health-Related Quality of Life
assessment of generic health-related quality of life, higher scores represent improved quality of life
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)

Full Information

First Posted
May 25, 2022
Last Updated
June 28, 2022
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
VA Office of Research and Development, Indiana Institute for Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT05426941
Brief Title
Feasibility and Acceptability of Music Therapy for Chronic Pain
Acronym
FAMILIA
Official Title
Feasibility and Acceptability of Music Imagery, and Listening Interventions for Analgesia (FAMILIA)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
VA Office of Research and Development, Indiana Institute for Medical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music Imagery
Arm Type
Experimental
Arm 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.
Arm Title
Music Listening
Arm Type
Experimental
Arm 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.
Arm Title
Usual care
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Music Imagery
Other Intervention Name(s)
music therapy
Intervention Description
Up to 30 participants will be randomized to receive 8 weekly Music Imagery sessions over 8-12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Music Listening
Other Intervention Name(s)
music therapy
Intervention Description
Up to 15 participants will be randomized to independent music listening.
Primary Outcome Measure Information:
Title
Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments?
Description
Determine the feasibility of the music therapy interventions
Time Frame
at 3 months
Title
Aspects of the interventions do Veterans perceive to be most/least helpful or most/least liked?
Description
Assess participant acceptability of the music therapy interventions
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Numeric Rating Scale for Pain intensity
Description
assessment of severity of pain, scored 0 to 10 with higher scores representing more intense pain
Time Frame
Baseline, 1, 3, and 4 months
Title
Brief Pain Inventory - Pain interference subscale
Description
how does pain interfere with 7 activities, scored 0 to 10 with higher scores representing more interference of pain with activities
Time Frame
Baseline, 1, 3, and 4 months
Title
Brief Pain Catastrophizing Scale
Description
assessment of pain belief, scored 0 to 12 with higher scores representing more pain catastrophizing (worse outcome)
Time Frame
Baseline, 1, 3, and 4 months
Title
Centrality of Pain Scale
Description
assessment of pain coping, scored 10 to 50 with higher scores representing the belief that pain is central to individual's life (worse outcome)
Time Frame
Baseline, 1, 3, and 4 months
Title
Patient Global Impression of Change Scale
Description
assessment of treatment response, scored 1 to 7 with higher scores representing greater improvement from starting the intervention
Time Frame
1,3 and 4 months
Title
PROMIS Sleep Scale
Description
assessment of sleep quality, scored 1 to 5 with higher scores representing worse sleep quality (worse outcome)
Time Frame
Baseline, 1, 3, and 4 months
Title
PHQ-9 Depression Measure
Description
assessment of depression severity, scored 0 to 27 with higher scores representing more severe depression (worse outcome)
Time Frame
Baseline, 1, 3, and 4 months
Title
GAD-7 Anxiety Measure
Description
assessment of anxiety severity, scored 0 to 21 with higher scores representing more severe anxiety (worse outcome)
Time Frame
Baseline, 1, 3, and 4 months
Title
Perceived Stress Scale
Description
assessment of stress severity, scored 0 to 14 with higher scores representing more severe stress (worse outcome)
Time Frame
Baseline and 3 months
Title
EQ 5D Scale for Health-Related Quality of Life
Description
assessment of generic health-related quality of life, higher scores represent improved quality of life
Time Frame
Baseline and 3 months
Title
EQ 5D Scale for Health-Related Quality of Life
Description
assessment of generic health-related quality of life, scored 0 to 100 with higher scores represent improved quality of life (better outcome)
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barry Barker
Phone
317-988-4312
Email
Barry.Barker@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Bair
Phone
317-988-2058
Email
Matthew.Bair@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Bair
Organizational Affiliation
Roudebush VA Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maya Story
Organizational Affiliation
Roudebush VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roudebush VA Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barry Barker
Phone
317-988-4312
Email
Barry.Barker@va.gov
First Name & Middle Initial & Last Name & Degree
Matthew Bair
Phone
317-988-2058
Email
Matthew.Bair@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36136377
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.
Results Reference
derived

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Feasibility and Acceptability of Music Therapy for Chronic Pain

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