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

NCT05220202 | Recruiting DMC

• 2 other identifiers: IIR 20-256IRB # 1672072
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Back Pain; Depression; Aging; Musculoskeletal Pain

Keywords

Chronic Back Pain; Depression; Veterans; Aging; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Depressive symptoms, PHQ-9

  Baseline, Mid (~5 weeks), End (~3 months) and 6 months

• Arthritis self-efficacy

  Baseline, Mid (~5 weeks), End (~3 months) and 6 months

• Pain Catastrophizing

  Baseline, Mid (~5 weeks), End (~3 months) and 6 months

• Psychological resilience

  Baseline, Mid (~5 weeks), End (~3 months) and 6 months

• Pain Behavior

  Baseline, Mid (~5 weeks), End (~3 months) and 6 months

Study Arms (2)

Waitlist Control Group

NO INTERVENTION

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.

Behavior Intervention Group (MOTIVATE)

EXPERIMENTAL

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)

Interventions

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).

Also known as: MOTIVATE

Behavior Intervention Group (MOTIVATE)

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Dallas VA Medical Center: collaborator
• Michael E. DeBakey VA Medical Center: collaborator

Study Sites (2)

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

Dallas, Texas, 75216-7167, United States

RECRUITING

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

RECRUITING

MeSH Terms

Conditions

Depression; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Una E. Makris, MD MSc

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florine Pore-Brown, BS

CONTACT

(214) 857-3291; florine.pore-brown@va.gov

Una E Makris, MD MSc

CONTACT

(214) 857-0409; Una.Makris2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research staff conducting outcome assessments will be blinded to whether the subject is in active or waitlist group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This Randomized Clinical Trial will randomize to either MOTIVATE or a waitlist control

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: September 20, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)