Chronic PainFAMILIANCT05426941

Feasibility and Acceptability of Music Therapy for Chronic Pain

A study testing Music Imagery and Music Listening in people with Chronic Pain, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Chronic Pain
What is being tested?: Music Imagery and Music Listening
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2021to 30 Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Barry Barker contact

Matthew Bair contact

United States1 site, 1 recruiting

Roudebush VA Medical Center
Indianapolis, Indiana, 46202
Barry Barker, 317-988-4312, Barry.Barker@va.gov
Matthew Bair, 317-988-2058, Matthew.Bair@va.gov
Recruiting

Other trials in United States

About this study

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

Read the 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.

Conditions: Chronic Pain
Being tested: Music Imagery, Music Listening
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Music ImageryBehavioural
Also called music therapy
Up to 30 participants will be randomized to receive 8 weekly Music Imagery sessions over 8-12 weeks.
Music ListeningBehavioural
Also called music therapy
Up to 15 participants will be randomized to independent music listening.

Study groups in NCT05426941
Study group	Role	What they receive
Music Imagery	Experimental	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. Receives: Behavioral: Music Imagery
Music Listening	Experimental	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. Receives: Behavioral: Music Listening
Usual care	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: at 3 months

Secondary outcomes (11)

Numeric Rating Scale for Pain intensity
assessment of severity of pain, scored 0 to 10 with higher scores representing more intense pain
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202130 Sep 2023

First posted22 Jun 2022
Study start1 Sep 2021
Primary completion30 Aug 2023 (estimated)
Study completion30 Sep 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05426941
Sponsor's protocol ID: 1863501-22-C-20
Acronym: FAMILIA
Status last verified: Jun 2022
First submitted: 25 May 2022
Last updated: 1 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Story KM, Wasmuth S, Belkiewitz JM, Whalen C, Robb SL, Bravata DM, Bair MJ. Military veterans' perspectives on using music to manage chronic pain: themes from the feasibility and acceptability of music imagery and listening interventions for analgesia study. Front Neurol. 2025 Aug 6;16:1613220. doi: 10.3389/fneur.2025.1613220. eCollection 2025.
PubMed 40843263
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.
PubMed 36136377

Want to know more?

Barry Barker

317-988-4312

Barry.Barker@va.gov

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility and Acceptability of Music Imagery, and Listening Interventions for Analgesia (FAMILIA)
ClinicalTrials.gov ID: NCT05426941
Acronym / sponsor ID: FAMILIA / 1863501-22-C-20
Conditions: Chronic Pain
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
Collaborators: VA Office of Research and Development, Indiana Institute for Medical Research
Study start: 1 Sep 2021 (actual)
Primary completion: 30 Aug 2023 (estimated)
Study completion: 30 Sep 2023 (estimated)
First posted: 22 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Music Imagery	Experimental	Behavioral: Music ImageryMI 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.
Music Listening	Experimental	Behavioral: Music ListeningFollowing 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.
Usual care	No intervention	–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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Music ImageryAlso: music therapyUp to 30 participants will be randomized to receive 8 weekly Music Imagery sessions over 8-12 weeks.	Behavioural	Music Imagery
Music ListeningAlso: music therapyUp to 15 participants will be randomized to independent music listening.	Behavioural	Music Listening

Primary outcome

Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments?
Time frame: at 3 months
Determine the feasibility of the music therapy interventions
Aspects of the interventions do Veterans perceive to be most/least helpful or most/least liked?
Time frame: at 3 months
Assess participant acceptability of the music therapy interventions

11 secondary outcomes

Numeric Rating Scale for Pain intensity
Time frame: Baseline, 1, 3, and 4 months
Brief Pain Inventory - Pain interference subscale
Time frame: Baseline, 1, 3, and 4 months
Brief Pain Catastrophizing Scale
Time frame: Baseline, 1, 3, and 4 months
Centrality of Pain Scale
Time frame: Baseline, 1, 3, and 4 months
Patient Global Impression of Change Scale
Time frame: 1,3 and 4 months
PROMIS Sleep Scale
Time frame: Baseline, 1, 3, and 4 months
PHQ-9 Depression Measure
Time frame: Baseline, 1, 3, and 4 months
GAD-7 Anxiety Measure
Time frame: Baseline, 1, 3, and 4 months
Perceived Stress Scale
Time frame: Baseline and 3 months
EQ 5D Scale for Health-Related Quality of Life
Time frame: Baseline and 3 months
EQ 5D Scale for Health-Related Quality of Life
Time frame: Baseline and 3 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
Derived from this study: PubMed 40843263Story KM, Wasmuth S, Belkiewitz JM, Whalen C, Robb SL, Bravata DM, Bair MJ. Military veterans' perspectives on using music to manage chronic pain: themes from the feasibility and acceptability of music imagery and listening interventions for analgesia study. Front Neurol. 2025 Aug 6;16:1613220. doi: 10.3389/fneur.2025.1613220. eCollection 2025.
Derived from this study: PubMed 36136377Story 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.
Individual participant dataSharing planned: No

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RecruitingObservational study
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Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Barry Barker contact

Matthew Bair contact

Matthew Bair principal investigator

Roudebush VA Medical Center

Maya Story principal investigator

Roudebush VA Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Music Imagery and Music Listening in people with Chronic Pain, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Barry Barker (317-988-4312, Barry.Barker@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments? (time frame: at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05426941, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.