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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Up to 30 participants will be randomized to receive 8 weekly Music Imagery sessions over 8-12 weeks.
Up to 15 participants will be randomized to independent music listening.
Roudebush VA Medical Center
Indianapolis, Indiana, United States
RECRUITINGPercentage 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
Time frame: 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
Time frame: at 3 months
Numeric Rating Scale for Pain intensity
assessment of severity of pain, scored 0 to 10 with higher scores representing more intense pain
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Baseline and 3 months