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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Musculoskeletal Pain; Aging; Chronic Back Pain
• Intervention / Treatment: Behavioral: Behavioral Intervention Group (MOTIVATE)

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 Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florine Pore-Brown, BS; Phone Number: (214) 857-3291; Email: florine.pore-brown@va.gov
• Study Contact Backup: Name: Una E Makris, MD MSc; Phone Number: (214) 857-0409; Email: Una.Makris2@va.gov

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75216-7167
      • Recruiting
      • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
      • Principal Investigator: Una E. Makris, MD MSc
      • Contact: Florine Pore-Brown, BS; Phone Number: 214-857-3291; Email: florine.pore-brown@va.gov
    • Houston, Texas, United States, 77030-4211
      • Recruiting
      • Michael E. DeBakey VA Medical Center, Houston, TX
      • Contact: Thach Tran; Phone Number: 832-272-4982; Email: thach.tran@va.gov
      • Contact: Natalie E Hundt, PhD; Phone Number: (713) 440-4450; Email: Natalie.Hundt@va.gov
      • Sub-Investigator: Natalie E Hundt, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist Control Group; The waitlist control group will continue with usual care management of musculoskeletal pain and depression. 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. Subjects randomized to the waitlist control group will be offered the intervention once they have completed the end outcomes assessment.
Experimental: Behavior 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.	Behavioral: Behavioral 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).; Other Names: MOTIVATE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome: Pain interference	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.	3 months post baseline or completion of MOTIVATE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms, PHQ-9	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	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Arthritis self-efficacy	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	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Pain Catastrophizing	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Psychological resilience	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Pain Behavior	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Quality of Life using PROMIS Global Health Scale	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Social Functioning	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Sleep Disturbance	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Insomnia Severity Index	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Patient Global Impression of change scale	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"	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
FRAIL scale	FRAIL measures frailty among older adults. scoring consist of 5 questions: 1-2+ pre-frail; 3+ frail	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Anxiety	PROMIS Anxiety short forms will assess anxiety symptoms. scale range 1-5: 1 (never) to 5 (always)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Therapeutic Alliance	therapeutic alliance assessed using the Working Alliance Inventory Short-Form	Mid (~5 weeks), End (~3 months)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Michael E. DeBakey VA Medical Center; Dallas VA Medical Center
• Investigators: Principal Investigator: Una E. Makris, MD MSc, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Veterans; Aging; Musculoskeletal Pain; Chronic Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Mental Disorders; Behavioral Symptoms; Mood Disorders; Back Pain; Musculoskeletal Pain; Depression; Depressive Disorder
• Other Study ID Numbers: IIR 20-256; IRB # 1672072 (Other Identifier: Dallas VA Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No