Chronic Pain
Conditions
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.
Interventions
BEHAVIORALMusic Imagery
Up to 30 participants will be randomized to receive 8 weekly Music Imagery sessions over 8-12 weeks.
BEHAVIORALMusic Listening
Up to 15 participants will be randomized to independent music listening.
Sponsors
VA Office of Research and Development
Indiana Institute for Medical Research
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Determine the feasibility of the music therapy interventions |
| Aspects of the interventions do Veterans perceive to be most/least helpful or most/least liked? | at 3 months | Assess participant acceptability of the music therapy interventions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Catastrophizing Scale | Baseline, 1, 3, and 4 months | assessment of pain belief, scored 0 to 12 with higher scores representing more pain catastrophizing (worse outcome) |
| Centrality of Pain Scale | Baseline, 1, 3, and 4 months | 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 | 1,3 and 4 months | assessment of treatment response, scored 1 to 7 with higher scores representing greater improvement from starting the intervention |
| PROMIS Sleep Scale | Baseline, 1, 3, and 4 months | assessment of sleep quality, scored 1 to 5 with higher scores representing worse sleep quality (worse outcome) |
| Numeric Rating Scale for Pain intensity | Baseline, 1, 3, and 4 months | assessment of severity of pain, scored 0 to 10 with higher scores representing more intense pain |
| GAD-7 Anxiety Measure | Baseline, 1, 3, and 4 months | assessment of anxiety severity, scored 0 to 21 with higher scores representing more severe anxiety (worse outcome) |
| Perceived Stress Scale | Baseline and 3 months | 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 | Baseline and 3 months | assessment of generic health-related quality of life, higher scores represent improved quality of life |
| PHQ-9 Depression Measure | Baseline, 1, 3, and 4 months | assessment of depression severity, scored 0 to 27 with higher scores representing more severe depression (worse outcome) |
| Brief Pain Inventory - Pain interference subscale | Baseline, 1, 3, and 4 months | how does pain interfere with 7 activities, scored 0 to 10 with higher scores representing more interference of pain with activities |
Countries
United States
Contacts
Primary ContactBarry Barker
Backup ContactMatthew Bair
Outcome results
None listed