MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Back Pain
- Sponsor
- VA Office of Research and Development
- Enrollment
- 264
- Locations
- 4
- Primary Endpoint
- Primary Outcome: Pain interference
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 60 and older
- •English- speaking
- •Self-reported MSK pain (include cLBP +/- radiating symptoms, 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 PEG-3
- •Depressive symptoms, 10+ on PHQ-9
- •Capable of participating in home-based activity
- •Interested in participating in a non-pharmacologic program
Exclusion Criteria
- •Aged 59 or less
- •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 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)
Outcomes
Primary Outcomes
Primary Outcome: Pain interference
Time Frame: 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 Outcomes
- Pain Catastrophizing(Baseline, Mid (~5 weeks), End (~3 months) and 6 months)
- Quality of Life using PROMIS Global Health Scale(Baseline, Mid (~5 weeks), End (~3 months) and 6 months)
- Patient Global Impression of change scale(Baseline, Mid (~5 weeks), End (~3 months) and 6 months)
- Anxiety(Baseline, Mid (~5 weeks), End (~3 months) and 6 months)
- Depressive symptoms, PHQ-9(Baseline, Mid (~5 weeks), End (~3 months) and 6 months)
- Pain Behavior(Baseline, Mid (~5 weeks), End (~3 months) and 6 months)
- Arthritis self-efficacy(Baseline, Mid (~5 weeks), End (~3 months) and 6 months)
- Therapeutic Alliance(Mid (~5 weeks), End (~3 months))
- Social Functioning(Baseline, Mid (~5 weeks), End (~3 months) and 6 months)
- Sleep Disturbance(Baseline, Mid (~5 weeks), End (~3 months) and 6 months)
- Insomnia Severity Index(Baseline, Mid (~5 weeks), End (~3 months) and 6 months)
- Psychological resilience(Baseline, Mid (~5 weeks), End (~3 months) and 6 months)
- FRAIL scale(Baseline, Mid (~5 weeks), End (~3 months) and 6 months)