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NCT Number: NCT05220202

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

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.

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Key information

Conditions

Chronic Back Pain Aging Behavior Behavioral Symptoms Depression Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Behavioral Intervention Group (MOTIVATE)

Behavioral

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).

Other names: MOTIVATE

Primary outcomes

  1. 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

  1. Depressive symptoms, PHQ-9

    Time frame: 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

  2. Arthritis self-efficacy

    Time frame: 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

  3. Pain Catastrophizing

    Time frame: 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)

  4. Psychological resilience

    Time frame: 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)

  5. Pain Behavior

    Time frame: 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)

  6. Quality of Life using PROMIS Global Health Scale

    Time frame: 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)

  7. Social Functioning

    Time frame: 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)

  8. Sleep Disturbance

    Time frame: 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)

  9. Insomnia Severity Index

    Time frame: 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)

  10. Patient Global Impression of change scale

    Time frame: 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"

  11. FRAIL scale

    Time frame: 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

  12. Anxiety

    Time frame: 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)

  13. Therapeutic Alliance

    Time frame: Mid (~5 weeks), End (~3 months)

    therapeutic alliance assessed using the Working Alliance Inventory Short-Form

Study contacts

Contact information is provided by the study sponsor or research team.

Florine Pore-Brown, BS

CONTACT

[email protected]

(214) 857-3291

Una E Makris, MD MSc

CONTACT

[email protected]

(214) 857-0409

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Dallas VA Medical Center
  • Michael E. DeBakey VA Medical Center

Registry information

Acronym: MOTIVATE_IIR

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2022
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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