Aging, Chronic Back Pain, Depression, Musculoskeletal Pain
Conditions
Keywords
Chronic Back Pain, Depression, Veterans, Aging, Musculoskeletal Pain
Brief summary
The proposed study seeks to evaluate effectiveness, implementation processes, and cost of MOTIVATE among older Veterans with chronic musculoskeletal (MSK) pain and comorbid depressive symptoms.
Detailed description
Investigators will conduct a randomized controlled trial (RCT) at two large VA facilities, to establish the effectiveness and scalability of MOTIVATE, a remotely delivered behavioral intervention for older Veterans with comorbid musculoskeletal (MSK) pain and depressive symptoms. The central hypothesis is that MOTIVATE will improve important patient-centered outcomes among older Veterans with co-occurring MSK pain and depressive symptoms.
Interventions
BEHAVIORALBehavioral Intervention Group (MOTIVATE)
Behavioral: Behavioral Intervention Group (MOTIVATE) The behavioral intervention is designed for older Veterans with musculoskeletal pain and depression and will include 8 individual telephone sessions delivered by health coaches (for up to 5 months total), accounting for additional time between sessions (if needed).
Sponsors
VA Office of Research and Development
Dallas VA Medical Center
Michael E. DeBakey VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The research staff conducting outcome assessments will be blinded to whether the subject is in active or waitlist group.
Intervention model description
This Randomized Clinical Trial will randomize to either MOTIVATE or a waitlist control
Eligibility
Sex/Gender
ALL
Age
60 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* English- speaking * Self-reported musculoskeletal (MSK) pain (include Chronic low back pain (cLBP) +/- radiating symptoms, osteoarthritis (OA), fibromyalgia) on most days for the past 3 months that interferes with daily activities * Pain intensity that is 4+/10 on the numerical pain rating scale * Pain interference threshold 5+ on 3-item Pain, Enjoyment of Life, and General Activity scale (PEG-3) * Depressive symptoms, 10+ on the Patient Health Questionnaire-9 (PHQ-9) * Capable of participating in home-based activity * Interested in participating in a non-pharmacologic program
Exclusion criteria
* No telephone * Not English speaking * Unwilling to be randomized to either study arm * Not interested in participating in a non-pharmacologic program * Self-reported uncorrected hearing and visual impairments precluding ability to participate in telephone sessions or read pedometer screen * Significant (moderate or severe) cognitive impairment (3+ errors) on six-item screening exam * Self-reported dependence on wheelchair, bed-bound, or severe balance impairment or severe osteoarthritis (OA)\* (resulting in inability to participate in physical activity intervention) * Illness requiring hospitalization within the last 3 months that interferes with a home-based physical activity intervention (e.g., fall, gout attack, stroke, heart attack, heart failure, surgery for blocked arteries) * Suicidal intent (see suicide screening protocol), uncontrolled psychotic disorder or psychiatric hospitalization within 1 year, or enrolled in active substance use program (confirmed with scripted protocol over telephone)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome: Pain interference | 3 months post baseline or completion of MOTIVATE | Pain interference will be assessed using the interference subscale of the Brief Pain Inventory (BPI) score at 3 months post-baseline or completion of MOTIVATE. Patient-reported pain-related interference (0-10 scale, with higher values indicating more pain) has been shown to be sensitive to change and to have good reliability. A mean between-group difference of 1-point in the primary outcome (change of BPI interference score from baseline to 3 months) is considered a clinically meaningful difference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms, PHQ-9 | Baseline, Mid (~5 weeks), End (~3 months) and 6 months | Depressive symptom severity will be assessed using the PHQ-9, a validated 9 question instrument used for monitoring and measuring the severity of depression symptoms. A cutoff score of \>10 signifies clinically meaningful symptom burden |
| Arthritis self-efficacy | Baseline, Mid (~5 weeks), End (~3 months) and 6 months | Arthritis self-efficacy scale is a 10 point Likert scale that measures the belief or confidence the subject has to perform 8 specific activities or tasks, based on arthritis Scale range 1-10: 1) very uncertain to 10) very certain |
| Psychological resilience | Baseline, Mid (~5 weeks), End (~3 months) and 6 months | Psychological resilience will be measured by Connor-Davidson Resilience Scale (CD-RISC). scale range 0-4: 0 (not at all) to 4 (all the time) |
| Pain Behavior | Baseline, Mid (~5 weeks), End (~3 months) and 6 months | NIH PROMIS short forms, for pain behavior have shown to have excellent psychometric properties in chronic pain. Scale range 1-6: 1 (No pain) to 6 (Always) |
| Quality of Life using PROMIS Global Health Scale | Baseline, Mid (~5 weeks), End (~3 months) and 6 months | NIH PROMIS short forms, for quality of life (PROMIS Global Health scale (physical and mental health) have shown to have excellent psychometric properties in chronic pain. Scale range 5-1: 5 (Excellent) to 1 (Poor) |
| Social Functioning | Baseline, Mid (~5 weeks), End (~3 months) and 6 months | NIH PROMIS short forms, for social functioning have shown to have excellent psychometric properties in chronic pain. Scale range 1-5: 1 (Never) to 5 (Always) |
| Sleep Disturbance | Baseline, Mid (~5 weeks), End (~3 months) and 6 months | 8-item PROMIS Sleep disturbance short form is well validated using objective sleep assessment tools (e.g., actigraphy) and used routinely in chronic pain patients and older adults. Scale range 5-1: 5 (very poor) to 1 (very good) |
| Insomnia Severity Index | Baseline, Mid (~5 weeks), End (~3 months) and 6 months | The 7-item Insomnia severity index (ISI) will assess severity of both nighttime and daytime components of insomnia scale ranges: 0 - 7 No clinically significant insomnia; 8 - 14 Subthreshold insomnia; 15 - 21 Clinical insomnia (moderate severity); 22 - 28 Clinical insomnia (severe) |
| FRAIL scale | Baseline, Mid (~5 weeks), End (~3 months) and 6 months | FRAIL measures frailty among older adults. scoring consist of 5 questions: 1-2+ pre-frail; 3+ frail |
| Anxiety | Baseline, Mid (~5 weeks), End (~3 months) and 6 months | PROMIS Anxiety short forms will assess anxiety symptoms. scale range 1-5: 1 (never) to 5 (always) |
| Therapeutic Alliance | Mid (~5 weeks), End (~3 months) | therapeutic alliance assessed using the Working Alliance Inventory Short-Form |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORUna E. Makris, MD MSc
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Outcome results
None listed