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) — BEHAVIORALBehavioral: 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 GroupThe 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
- Florine Pore-Brown, BS(214) 857-3291
- Una E Makris, MD MSc(214) 857-0409
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas | 75216-7167 | Una E. Makris, MD MSc (PRINCIPAL_INVESTIGATOR) |
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030-4211 | Natalie E Hundt, PhD (SUB_INVESTIGATOR) |
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