MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression
- Conditions
- AgingChronic Back PainDepressionMusculoskeletal Pain
- Interventions
- Behavioral: Behavioral Intervention Group (MOTIVATE)
- Registration Number
- NCT05220202
- Lead Sponsor
- VA Office of Research and Development
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 264
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Behavior Intervention Group (MOTIVATE) Behavioral Intervention Group (MOTIVATE) For participants assigned to the intervention arm, trained health coaches will deliver the 8 session intervention via telephone. MOTIVATE users motivational interviewing techniques, values elicitation and physical activity based goal setting. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, midpoint, final assessments) conducted by a blinded research assistant.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pain Catastrophizing Baseline, Mid (~5 weeks), End (~3 months) and 6 months Pain catastrophizing, a prominent pain behavior construct, can influence response to treatment for chronic musculoskeletal pain. Scale range 0-4: 0 (not at all) to 4 (all the time)
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)
Patient Global Impression of change scale Baseline, Mid (~5 weeks), End (~3 months) and 6 months Patient Global Impression of Change Scale, recommended as a core outcome measure in pain trials, will be assessed. scoring range is 1-7: 1) "no change" to 7) "a great deal better"
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)
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
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)
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
Therapeutic Alliance Mid (~5 weeks), End (~3 months) therapeutic alliance assessed using the Working Alliance Inventory Short-Form
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)
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)
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
Trial Locations
- Locations (2)
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
🇺🇸Dallas, Texas, United States
Michael E. DeBakey VA Medical Center, Houston, TX
🇺🇸Houston, Texas, United States