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

Part of paid clinical trials in Dallas, Texas.

Sponsor
VA Office of Research and Development
Study ID
NCT05220202
Status
Recruiting

Conditions

  • Aging
  • Chronic Back Pain
  • Depression
  • Musculoskeletal Pain

Eligibility Criteria

Sex
ALL
Age
60 Years - 99 Years
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

Start date
Sep 20, 2023
Status verified
Aug 2025
Primary completion
Oct 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
264 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.

Primary Outcome Measure

Primary Outcome: Pain interference [ Time Frame: 3 months post baseline or completion of MOTIVATE ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXDallasTexas75216-7167
Florine Pore-Brown, BS
214-857-3291
Una E. Makris, MD MSc (PRINCIPAL_INVESTIGATOR)
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-4211
Thach Tran
832-272-4982
Natalie E Hundt, PhD
(713) 440-4450
Natalie E Hundt, PhD (SUB_INVESTIGATOR)

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