Feasibility and Acceptability of Music Therapy for Chronic Pain

Chronic Pain Clinical Trial

— FAMILIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05426941
• Other study ID #: 1863501-22-C-20
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2022
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: Barry Barker
• Phone: 317-988-4312
• Email: Barry.Barker[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (ML) intervention and a multi-component, more interactive music imagery (MI) intervention.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Music Imagery
Up to 30 participants will be randomized to receive 8 weekly Music Imagery sessions over 8-12 weeks.
• Music Listening
Up to 15 participants will be randomized to independent music listening.

Locations

Country	Name	City	State
United States	Roudebush VA Medical Center	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	Indiana Institute for Medical Research, VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Perceived Stress Scale	assessment of stress severity, scored 0 to 14 with higher scores representing more severe stress (worse outcome)	Baseline and 3 months
Secondary	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
Secondary	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