Status:
RECRUITING
MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Dallas VA Medical Center
Michael E. DeBakey VA Medical Center
Conditions:
Chronic Back Pain
Depression
Eligibility:
All Genders
60-99 years
Phase:
NA
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.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT05220202
Start Date
September 20 2023
End Date
December 1 2026
Last Update
August 20 2025
Active Locations (2)
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1
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216-7167
2
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211