MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression

Not Applicable

Recruiting

• Conditions: Aging; Chronic Back Pain; Depression; Musculoskeletal Pain

• 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.

Study Timeline

• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-02
• Study Start: 2023-09-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26
• Primary Completion: 2026-10-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 264

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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